Author: "Leleu, A" / Topic: hematology - Searchworks@Jio Institute Digital Library Search Results

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596 results on '"Leleu, A"'

1. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma

Author: Costello, Caitlin, Davies, Faith E, Cook, Gordon, Vela-Ojeda, Jorge, Omel, Jim, Rifkin, Robert M, Berdeja, Jesus, Puig, Noemi, Usmani, Saad Z, Weisel, Katja, Zonder, Jeffrey A, Terpos, Evangelos, Spencer, Andrew, Leleu, Xavier, Boccadoro, Mario, Thompson, Michael A, Romanus, Dorothy, Stull, Dawn M, and Hungria, Vania
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Comparative Effectiveness Research, Hematology, Orphan Drug, Rare Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Disease Progression, Follow-Up Studies, Humans, International Agencies, Middle Aged, Multiple Myeloma, Neoplasm Recurrence, Local, Prospective Studies, Quality of Life, Treatment Outcome, Young Adult, multiple myeloma, observational study, treatment, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract: With the introduction of new drugs with different mechanisms of action, multiple myeloma (MM) patients' outcomes have improved. However, the efficacy seen in clinical trials is often not seen in real-world settings and data on the effectiveness of MM therapies are needed. INSIGHT MM is a prospective, global, non-interventional, observational study that is enrolling approximately 4200 patients with newly diagnosed or relapsed/refractory MM, making it the largest study of its kind to date. The study aims to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapies chosen, clinical outcomes (response, treatment duration, time-to-next-therapy, progression-free and overall survival), safety, healthcare resource utilization and quality of life. One interim analysis has been conducted to date; current accrual is approximately 3094 patients. Trial registration number: NCT02761187.
Published: 2019

2. Biallelic deletion of 1p32 defines ultra-high-risk myeloma, but monoallelic del(1p32) remains a strong prognostic factor

Author: Anaïs Schavgoulidze, Alexis Talbot, Aurore Perrot, Titouan Cazaubiel, Xavier Leleu, Salomon Manier, Laure Buisson, Sabrina Mahéo, Laura Do Souto Ferreira, Luka Pavageau, Cyrille Hulin, Jean-Pierre Marolleau, Laurent Voillat, Karim Belhadj, Marion Divoux, Borhane Slama, Sabine Brechignac, Margaret Macro, Anne-Marie Stoppa, Laurence Sanhes, Frédérique Orsini-Piocelle, Jean Fontan, Marie-Lorraine Chretien, Hélène Demarquette, Mohamad Mohty, Hervé Avet-Loiseau, and Jill Corre
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Abstract: Cytogenetic abnormalities (CAs) are known to be the preponderant prognostic factor in multiple myeloma. Our team has recently developed a prognostic score based on 6 CAs, with which del(1p32) appears to be the second worst abnormality after del(17p). This study aimed to confirm the adverse effect of 1p32 deletion in patients with newly diagnosed multiple myeloma (NDMM). Among 2551 patients with newly diagnosed multiple myeloma, 11% were harboring del(1p32). Their overall survival (OS) was significantly inferior compared with patients without del(1p32) (median OS: 49 months vs 124 months). Likewise, progression-free survival was significantly shorter. More importantly, biallelic del(1p32) conferred a dramatically poorer prognosis than a monoallelic del(1p32) (median OS: 25 months vs 60 months). As expected, the OS of patients with del(1p32) significantly decreased when this abnormality was associated with other high-risk CAs [del(17p), t(4;14), or gain(1q)]. In the multivariate analysis, del(1p32) appeared as a negative prognostic factor; after adjustment for age and treatment, the risk of progression was 1.3 times higher among patients harboring del(1p32), and the risk of death was 1.9 times higher. At the dawn of risk-adapted treatment strategies, we have confirmed the adverse effect of del(1p32) in multiple myeloma and the relevance of its assessment at diagnosis.
Published: 2023
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3. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients

Author: Michael A. Thompson, Mario Boccadoro, Xavier Leleu, Jorge Vela-Ojeda, Frits van Rhee, Katja C. Weisel, Robert M. Rifkin, Saad Z. Usmani, Roman Hájek, Gordon Cook, Rafat Abonour, Mira Armour, Kathryn E. Morgan, Su-Peng Yeh, Caitlin L. Costello, Jesus G. Berdeja, Faith E. Davies, Jeffrey A. Zonder, Hans C. Lee, Jim Omel, Andrew Spencer, Evangelos Terpos, Vania T.M. Hungria, Noemi Puig, Chengcheng Fu, Renda H. Ferrari, Kaili Ren, Dawn Marie Stull, and Ajai Chari
Subjects: Cancer Research, Oncology, Hematology
Published: 2023
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4. Impact of donor ferritin testing on iron deficiency prevention and blood availability in France: A cohort simulation study

Author: Pascale Richard, Anne‐Marie Fillet, Lucile Malard, Carole Leclerc, Claire Chanut, Geneviève Woimant, Chantal Jacquot, Henri Leleu, Pascal Morel, and Alexandre Vimont
Subjects: Hematology, General Medicine
Abstract: Implementing a ferritin testing policy for whole blood (WB) donors may prevent iron deficiency (ID, ferritin26 ng/mL) and anaemia, but may induce donation losses. As part of a national prevention plan in France, we aimed to estimate its impact on ID, anaemias and WB donations among donors at high risk of ID.A micro-simulation model was developed to evaluate different scenarios compared to the current situation without ferritin testing as a reference scenario. The following scenarios were simulated: a minimum scenario with a 6-month deferral for donors with absent iron store (AIS, ferritinemia15 ng/ml), a main scenario with additional delayed invitations for donors with ferritinemia 15-25 ng/ml and a supplementation scenario with additional iron supplementation for 50% of the donors with AIS.In the main scenario, 52,699 WB donations per year were estimated to be lost after 1 year (-8%), falling to 27,687 (-4.7%) after 5 years. IDs and anaemias were reduced by 13.6% and 29.3%, respectively, after 1 year. The supplementation scenario increased the number of prevented IDs and anaemias to 24.1% and 35.4%, respectively, after 1 year, and halved the number of anaemias at 5 years. The latter scenario also had the least impact on the number of donations (-3.2% after 5 years).A ferritin testing policy resulting in delayed donations for ID donors is effective in reducing IDs and anaemias, but significantly impacts the number of donations, thereby posing a self-sufficiency challenge.
Published: 2022
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5. Daratumumab Plus Lenalidomide and Dexamethasone in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Maia Age Subgroup Analysis

Author: Thierry Facon, Shaji K Kumar, Katja Weisel, Saad Usmani, Philippe Moreau, Torben Plesner, Robert Z. Orlowski, Nizar Jacques Bahlis, Supratik Basu, Hareth Nahi, Cyrille Hulin, Hang Quach, Michael O'Dwyer, Aurore Perrot, Christopher P. Venner, Noopur Raje, Mourad Tiab, Margaret Macro, Laurent Frenzel, Xavier Leleu, Huiling Pei, Robin Carson, Fredrik Borgsten, and Hartmut Goldschmidt
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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6. Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) Alone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of the Phase 3 Maia Study

Author: Shaji K Kumar, Philippe Moreau, Nizar Jacques Bahlis, Thierry Facon, Torben Plesner, Robert Z. Orlowski, Supratik Basu, Hareth Nahi, Cyrille Hulin, Hang Quach, Hartmut Goldschmidt, Michael O'Dwyer, Aurore Perrot, Christopher P. Venner, Katja Weisel, Noopur Raje, Mourad Tiab, Margaret Macro, Laurent Frenzel, Xavier Leleu, Huiling Pei, Maria Krevvata, Robin Carson, Fredrik Borgsten, and Saad Usmani
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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7. Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Transplant-Ineligible Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM): Clinical Assessment of Key Subgroups of the Phase 3 Maia Study

Author: Philippe Moreau, Thierry Facon, Saad Usmani, Nizar Jacques Bahlis, Noopur Raje, Torben Plesner, Robert Z. Orlowski, Supratik Basu, Hareth Nahi, Cyrille Hulin, Hang Quach, Hartmut Goldschmidt, Michael O'Dwyer, Aurore Perrot, Christopher P. Venner, Katja Weisel, Mourad Tiab, Margaret Macro, Laurent Frenzel, Xavier Leleu, Huiling Pei, Maria Krevvata, Robin Carson, Fredrik Borgsten, and Shaji K Kumar
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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8. Heterogeneity in long-term outcomes for patients with Revised International Staging System stage II, newly diagnosed multiple myeloma

Author: Anais Schavgoulidze, Valerie Lauwers-Cances, Aurore Perrot, Titouan Cazaubiel, Marie-Lorraine Chretien, Philippe Moreau, Thierry Facon, Xavier Leleu, Lionel Karlin, Anne-Marie Stoppa, Olivier Decaux, Karim Belhadj, Bertrand Arnulf, Mohamad Mohty, Clara M Ariette, Cecile Fohrer-Sonntag, Pascal Lenain, Jean-Pierre Marolleau, Mourad Tiab, Carla Araujo, Frederique Orsini-Piocelle, Arnaud Jaccard, Murielle Roussel, Lotfi Benboubker, Jean-Richard Eveillard, Mamoun Dib, Marion Divoux, Michel Attal, Herve Avet-Loiseau, Jill Corre, Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherches en Cancérologie de Toulouse (CRCT), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service Hématologie - IUCT-Oncopole [CHU Toulouse], Pôle Biologie [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle IUCT [CHU Toulouse], CHU Bordeaux [Bordeaux], Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Lille, Service d'Hématologie [CHU Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Service d’Hématologie [Institut Paoli Calmettes, Marseille], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), CHU Pontchaillou [Rennes], Microenvironment and B-cells: Immunopathology,Cell Differentiation, and Cancer (MOBIDIC), Université de Rennes (UR)-Etablissement français du sang [Rennes] (EFS Bretagne)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Henri Mondor, Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Grenoble, Hôpital de Hautepierre [Strasbourg], Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), CHU Amiens-Picardie, Hématologie clinique [CH La Roche-sur-Yon], Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Centre Hospitalier de la Côte Basque (CHCB), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges], CHU Limoges, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service d'Hématologie [CHRU Nancy], and Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)
Subjects: Hematology, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: In the era of personalized treatment in multiple myeloma, high-risk patients must be accurately identified. The International Myeloma Working Group recommends using the Revised International Staging System (R-ISS) to pick out high-risk patients. The main purpose of our work was to explore the heterogeneity of outcome among R-ISS stage II patients assessing the impact of International Staging System (ISS) stage, chromosomal abnormalities and lactate dehydrogenase level in this subgroup. Data were collected from 1,343 patients up to 65 years old with newly diagnosed myeloma, enrolled in three clinical trials implemented by the Intergroupe Francophone du Myélome. All patients were eligible for intensive treatment. Patients in R-ISS stage II but ISS stage I had 1.6 times higher risk of death than patients in R-ISS stage I (adjusted hazard ratio=1.6; 95% confidence interval: 1.1-2.2; P=0.01) and patients in R-ISS stage II but with ISS stage III had a better overall survival than patients in R-ISS stage III (adjusted hazard ratio=0.7; 95% confidence interval: 0.4-0.9, P=0.02). However, among patients classified in R-ISS II, ISS stage and chromosomal abnormalities (del[17p] and t[4;14]) were still relevant prognostic factors for death. Dividing R-ISS stage II into three subgroups: ISS I with standard-risk chromosomal abnormalities, ISS II or III with standard-risk chromosomal abnormalities and patients with high-risk chromosomal abnormalities, median overall survival times were, respectively, not reached, 112 months and 71 months (P
Published: 2022
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9. Survival outcomes for patients with multiple myeloma in France: A retrospective cohort study using the Système National des Données de Santé national healthcare database

Author: Xavier Leleu, Boris Gorsh, Antoine Bessou, Prani Paka, Julie De Nascimento, Xavier Colin, Suzanne Landi, and Peter Feng Wang
Subjects: Hematology, General Medicine
Published: 2023
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10. Final Analysis of Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone in the CANDOR Study

Author: Saad Z. Usmani, Hang Quach, Maria-Victoria Mateos, Ola Landgren, Xavier Leleu, David S. Siegel, Katja C. Weisel, Xiaomei Shu, Chuang Li, and Meletios A. Dimopoulos
Subjects: Hematology
Abstract: CANDOR (NCT03158688) is a phase 3, randomized, open-label trial comparing carfilzomib, daratumumab, and dexamethasone (KdD) versus carfilzomib and dexamethasone (Kd) in adults with relapsed/refectory multiple myeloma (RRMM) with 1-3 prior therapies. The CANDOR study met its primary endpoint of progression-free survival (PFS) in the primary analysis. Here we report the final analysis of the study, including secondary endpoints and subgroup analyses thereof. Median follow-up was 50 months. Patients treated with KdD had higher minimal residual disease-negative (MRD-) achievement rates (28% vs 9%; odds ratio [OR], 4.22 [95% CI, 2.28-7.83]) and MRD- complete response rates (22% vs 8%; OR, 3.55 [1.83-6.88]) than those treated with Kd. Median PFS was 28.4 months for KdD versus 15.2 months for Kd (hazard ratio [HR], 0.64 [95% CI, 0.49-0.83]). Median overall survival (OS) was 50.8 months versus 43.6 months, respectively (HR, 0.78 [0.60-1.03]; P=0.042). Trends toward improved OS occurred in predefined subgroups, including patients refractory to lenalidomide (KdD, not reached; Kd, 38.2 months; HR, 0.69 [0.43-1.11]) and refractory to proteasome inhibitor (KdD, 43.2 months; Kd, 30.0 months; HR, 0.70 [0.45-1.09]), and there was significant improvement in patients with high-risk cytogenetics (KdD, 34.3 months; Kd: 17.1 months; HR, 0.52 [0.29-0.94]). No new safety signals were identified. In summary, the final analysis of CANDOR confirmed the PFS benefit and showed a trend in OS benefit with KdD versus Kd. These findings reinforce KdD as a standard of care for RRMM, especially in clinically relevant patient subgroups.
Published: 2023
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11. Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study

Author: Thomas Martin, Meletios-Athanasios Dimopoulos, Joseph Mikhael, Kwee Yong, Marcelo Capra, Thierry Facon, Roman Hajek, Ivan Špička, Ross Baker, Kihyun Kim, Gracia Martinez, Chang-Ki Min, Ludek Pour, Xavier Leleu, Albert Oriol, Youngil Koh, Kenshi Suzuki, France Casca, Sandrine Macé, Marie-Laure Risse, and Philippe Moreau
Subjects: Oncology, Hematology
Abstract: Longer-term outcomes with the anti-CD38 antibody isatuximab in combination with carfilzomib-dexamethasone (Isa-Kd) were evaluated in the randomized Phase 3 trial IKEMA (NCT03275285), in a prespecified, follow-up analysis of progression-free survival (PFS, primary study endpoint), final complete response (CR) using Hydrashift Isa immunofixation assay, minimal residual disease (MRD) negativity, and safety. Enrolled patients had relapsed/refractory multiple myeloma (1–3 prior treatment lines). Isa 10 mg/kg was administered intravenously weekly in cycle 1 then biweekly. Efficacy analyses were performed in the intent-to-treat population (Isa-Kd: n = 179, Kd: n = 123) and safety evaluated in treated patients (Isa-Kd: n = 177, Kd: n = 122). Consistent with the primary interim analysis, the addition of Isa to Kd prolonged PFS (HR 0.58, 95.4% CI: 0.42–0.79; median PFS 35.7 [95% CI: 25.8–44.0] vs 19.2 [95% CI: 15.8–25.0] months). PFS benefit was observed with Isa-Kd across subgroups, including patients with poor prognosis. The stringent CR/CR rate was 44.1% vs 28.5% (odds-ratio: 2.09, 95% CI: 1.26–3.48), the MRD negativity rate 33.5% vs 15.4% (odds-ratio: 2.78, 95% CI: 1.55–4.99) and the MRD negativity CR rate 26.3% vs 12.2%, with Isa-Kd vs Kd. The safety profile of Isa-Kd was similar to that reported in the prior interim analysis. These findings further support Isa-Kd as a standard-of-care treatment for relapsed multiple myeloma patients.Clinical trial information: ClinicalTrials.gov, NCT03275285.
Published: 2023
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12. Real-world study of the efficacy and safety of belantamab mafodotin (GSK2857916) in relapsed or refractory multiple myeloma based on data from the nominative ATU in France: IFM 2020-04 study

Author: Alexis Talbot, Arthur Bobin, Léa Tabone, Jérôme Lambert, Catherine Boccaccio, Cécile Deal, Marie-Odile Petillon, Olivier Allangba, Philippe Agape, Pierre Arnautou, Rakiba Belkhir, Sylvie Cailleres, Driss Chaoui, Marie-Lorraine Chrétien, Olivier Decaux, Samantha Schulmann, Laurent Frenzel, Lauris Gastaud, Antoine Huart, Cyrille Hulin, Lionel Karlin, Kamel Laribi, Ronan Le Calloch, Pascal Lenain, Margaret Macro, Salomon Manier, Lydia Montes, Stéphane Moreau, Philippe Moreau, Véronique Morel, James Norwood, Frédérique Orsini Piocelle, Aurore Perrot, Gian Matteo Pica, Philippe Rey, Anna Schmitt, Anne-Marie Stoppa, Mourad Tiab, Cyrille Touzeau, Valérie Vidal, Marguerite Vignon, Laure Vincent, Zoé Van De Wyngaert, Charles Zarnitsky, Naima Kerbouche, Prani Paka, Xavier Leleu, Bertrand Arnulf, Hervé Avet-Loiseau, and IFM: Intergroupe Francophone Du Myélome
Subjects: Hematology
Abstract: Belantamab mafodotin (BM) is an anti-BCMA antibody-drug conjugate (GSK2857916) that represents an alternative option in multiple myeloma. We sought to assess the efficacy and safety in real-world of BM in patients who benefited from an early access program. We conducted an observational, retrospective, multicenter study. Eligibility criteria were treatment of relapsed or refractory multiple myeloma (RRMM) in monotherapy in adult patients who have received at least 3 lines of therapy previously, including at least one immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody, and whose disease progressed during the last treatment period. The primary endpoint of the study is to assess the overall survival (OS). The trial was sponsored by the French group IFM and supported by GSK. Between November 2019 and December 2020, 106 patients were treated with BM; 97 were eligible for the efficacy evaluation and 104 for safety. The median age was 66 (range: 37–82) years. High risk cytogenetics were identified in 40.9% of patients. Fifty-five (56.7%) patients were triple-class refractory and 11 (11.3%) were penta-class refractory. The median number of prior lines of treatment was 5 (range: 3–12). The median number of BM cycles administered was 3 (range: 1–22). The overall response rate at best response was 38.1% (37/97). The median OS was 9.3 months (95%CI: 5.9; 15.3), and median progression-free survival was 3.5 months (95%CI: 1.9; 4.7). The median duration of response was 9 months (range 4.65-10.4). Treatment was delayed for 55 (52.9%) patients including 36.5% for treatment-related toxicity. Ophthalmic adverse events, mainly grade ≤2, were the most common toxicity (48%). The occurrence of keratopathy was 37.5%. Overall, our data are concordant with the results from DREAMM-2 in terms of efficacy and safety on a non-biased population.
Published: 2023
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13. KarMMa-2 Cohort 2c: Efficacy and Safety of Idecabtagene Vicleucel in Patients with Clinical High-Risk Multiple Myeloma Due to Inadequate Response to Frontline Autologous Stem Cell Transplantation

Author: Madhav Dhodapkar, Melissa Alsina, Jesus Berdeja, Krina Patel, Ravi Vij, Xavier Leleu, Anna Truppel-Hartmann, Debashree Basudhar, Ethan Thompson, Xirong Zheng, Revathi Ananthakrishnan, Linda Favre-Kontula, Chiara Greggio, Lars Sternas, and David Siegel
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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14. Isatuximab Plus Carfilzomib and Dexamethasone in Patients with Early Versus Late Relapsed Multiple Myeloma: Ikema Subgroup Analysis

Author: Thierry Facon, Philippe Moreau, Ross Baker, Ludek Pour, Chang-Ki Min, Xavier Leleu, Mohamad Mohty, Lionel Karlin, Andreea Rawlings, Christina Tekle, Sandrine Schwab, Marie-Laure Risse, and Thomas Martin
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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15. Effectiveness and Safety of Belantamab Mafodotin in Patients with Relapsed or Refractory Multiple Myeloma in Real-Life Setting: The ALFA Study

Author: Murielle Roussel, Nathalie Texier, Raphaël Germain, Sandhya Sapra, Prani Paka, Naima Kerbouche, Xavier Colin, and Xavier Leleu
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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16. Isatuximab Plus Pomalidomide/Low-Dose Dexamethasone Versus Pomalidomide/Low-Dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (ICARIA-MM): Characterization of Subsequent Antimyeloma Therapies

Author: Paul G. Richardson, Aurore Perrot, Jesús San-Miguel, Meral Beksac, Ivan Spicka, Xavier Leleu, Fredrik Schjesvold, Philippe Moreau, Meletios A. Dimopoulos, Jeffrey SY Huang, Jiri Minarik, Michele Cavo, H. Miles Prince, Sandrine Macé, Laure Malinge, Franck Dubin, Mony Morisse, and Kenneth C. Anderson
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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17. French Early Nationwide Idecabtagene Vicleucel (Ide-Cel) Chimeric Antigen Receptor (CAR) T-Cell Therapy Experience in Patients with Relapsed/Refractory Multiple Myeloma (FENIX): An IFM Study from the Descar-T Registry

Author: Benoit Ferment, Jérôme Lambert, Denis Caillot, Ingrid Lafon, Lionel Karlin, Anne Lazareth, Cyrille Touzeau, Xavier Leleu, Niels Moya, Stephanie Harel, Aurore Perrot, Pierre Bories, Laure Vincent, Sylvain Lamure, Mohamad Mohty, Florent Malard, Salomon Manier, Ibrahim Yakoub-Agha, Anne-Marie Stoppa, Gabriel Brisou, Olivier Decaux, Roch Houot, Steven Le Gouill, Thierry Facon, Hervé Avet-Loiseau, Philippe Moreau, and Bertrand Arnulf
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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18. Trial in Progress: REGN5458, a BCMAxCD3 Bispecific Antibody, in a Phase Ib Multi-Cohort Study of Combination Regimens for Patients with Relapsed/Refractory Multiple Myeloma

Author: Paula Rodríguez Otero, Nisha S. Joseph, Shaji K Kumar, Hans C. Lee, Xavier Leleu, Salomon Manier, Meletios A. Dimopoulos, María Victoria Mateos, Albert Oriol, Naresh Bumma, Weiying Gong, Pourab Roy, Karen Rodriguez Lorenc, Glenn S. Kroog, and Shawn M. Sarkaria
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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19. Effectiveness and Safety of Ixazomib in Combination with Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma in a Real-Life Population in France: The Remix Study

Author: Laure Vincent, Anne Charvet-Rumpler, Lotfi Benboubker, Claire Calmettes, Anne-Marie Stoppa, Kamel Laribi, Lauriane Clement Filliatre, Fressia Honeyman, Richez Valentine, Cyrille Hulin, Frédéric Maloisel, Margaret Macro, Lionel Karlin, Vanessa Barué, Christos Chouaid, Hacène Zerazhi, and Xavier Leleu
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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20. KarMMa-2 Cohort 2a: Efficacy and Safety of Idecabtagene Vicleucel in Clinical High-Risk Multiple Myeloma Patients with Early Relapse after Frontline Autologous Stem Cell Transplantation

Author: Saad Usmani, Krina Patel, Parameswaran Hari, Jesus Berdeja, Melissa Alsina, Ravi Vij, Noopur Raje, Xavier Leleu, Madhav Dhodapkar, Ran Reshef, Anna Truppel-Hartmann, Debashree Basudhar, Ethan Thompson, Xirong Zheng, Revathi Ananthakrishnan, Chiara Greggio, Linda Favre-Kontula, Lars Sternas, and Jesús San-Miguel
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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21. Causes and Risk Factors of Early and Late Non-Relapse Mortality after CD19 CAR T-Cell Therapy for Diffuse Large B-Cell Lymphoma (DLBCL): A Lysa Study from the Descar-T Registry

Author: Jean Lemoine, Emmanuel Bachy, Guillaume Cartron, David Beauvais, Thomas Gastinne, Marie Thérèse Rubio, Xavier Leleu, Mohamad Mohty, René-Olivier Casasnovas, Magalie Joris, Cristina Castilla-LLorente, Corinne Haioun, Olivier Hermine, Michael Loschi, Sylvain Carras, Pierre Bories, Tom Fradon, Charles Herbaux, Pierre Sesques, Steven Le Gouill, Franck Morschhauser, Catherine Thieblemont, and Roch Houot
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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22. Nouvelles AMMs : Ciltacabtagene autoleucel – patients atteints d’un myélome multiple en rechute ou réfractaire après au moins trois lignes de traitements

Author: Aurélia Chacon, Arthur Bobin, and Xavier Leleu
Subjects: Cancer Research, Oncology, Radiology, Nuclear Medicine and imaging, Hematology, General Medicine
Published: 2022
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23. Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study

Author: Murielle Roussel, Valérie Lauwers-Cances, Margaret Macro, Xavier Leleu, Bruno Royer, Cyrille Hulin, Lionel Karlin, Aurore Perrot, Cyrille Touzeau, Marie-Lorraine Chrétien, Sophie Rigaudeau, Mamoun Dib, Emmanuelle Nicolas-Virelizier, Martine Escoffre-Barbe, Karim Belhadj, Clara Mariette, Anne-Marie Stoppa, Carla Araujo, Chantal Doyen, Jean Fontan, Brigitte Kolb, Laurent Garderet, Sabine Brechignac, Jean-Valère Malfuson, Arnaud Jaccard, Pascal Lenain, Cécile Borel, Benjamin Hebraud, Omar Benbrahim, Véronique Dorvaux, Salomon Manier, Karine Augeul-Meunier, Marie-Christiane Vekemans, Edouard Randriamalala, Driss Chaoui, Jo Caers, Carine Chaleteix, Lofti Benboubker, Laure Vincent, Sylvie Glaisner, Patricia Zunic, Borhane Slama, Jean-Richard Eveillard, Catherine Humbrecht-Kraut, Véronique Morel, Philippe Mineur, Jean-Claude Eisenmann, Hélène Demarquette, Valentine Richez, Marguerite Vignon, Denis Caillot, Thierry Facon, Philippe Moreau, Anne-Laurène Colin, Pascale Olivier, Soraya Wuilleme, Hervé Avet-Loiseau, Jill Corre, Michel Attal, UCL - (MGD) Service d'hématologie, and UCL - SSS/IREC/MONT - Pôle Mont Godinne
Subjects: Bortezomib, Antineoplastic Combined Chemotherapy Protocols, Immunology, Humans, Cell Biology, Hematology, Multiple Myeloma, Melphalan, Transplantation, Autologous, Biochemistry
Abstract: High-dose melphalan (HDM) and transplantation are recommended for eligible patients with multiple myeloma. No other conditioning regimen has proven to be more effective and/or safer. We previously reported in a phase 2 study that bortezomib can safely and effectively be combined with HDM (Bor-HDM), with a 32% complete response (CR) rate after transplantation. These data supported a randomized phase 3 trial. Randomization was stratified according to risk and response to induction: 300 patients were enrolled, and 154 were allocated to the experimental arm (ie, arm A) with bortezomib (1 mg/m2 intravenously [IV]) on days −6, –3, +1, and +4 and melphalan (200 mg/m2 IV) on day –2. The control arm (ie, arm B) consisted of HDM alone (200 mg/m2 IV). There were no differences in stringent CR + CR rates at day 60 posttransplant (primary end point): 22.1% in arm A vs 20.5% in arm B (P = .844). There were also no differences in undetectable minimum residual disease rates: 41.3% vs 39.4% (P = .864). Median progression-free survival was 34.0 months for arm A vs 29.6 months for arm B (adjusted HR, 0.82; 95% CI, 0.61-1.13; P = .244). The estimated 3-year overall survival was 89.5% in both arms (hazard ratio, 1.28; 95% CI, 0.62-2.64; P = .374). Sixty-nine serious adverse events occurred in 18.7% of Bor-HDM–treated patients (vs 13.1% in HDM-treated patients). The proportion of grade 3/4 AEs was similar within the 2 groups (72.0% vs 73.1%), mainly (as expected) blood and gastrointestinal disorders; 4% of patients reported grade 3/4 or painful peripheral neuropathy in arm A (vs 1.5% in arm B). In this randomized phase 3 study, a conditioning regimen with Bor-HDM did not improve efficacy end points or outcomes compared with HDM alone. The original trial was registered at www.clinicaltrials.gov as #NCT02197221.
Published: 2022
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24. Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study

Author: Fredrik H Schjesvold, Meletios-Athanasios Dimopoulos, Sosana Delimpasi, Pawel Robak, Daniel Coriu, Wojciech Legiec, Luděk Pour, Ivan Špička, Tamas Masszi, Vadim Doronin, Jiri Minarik, Galina Salogub, Yulia Alekseeva, Antonio Lazzaro, Vladimir Maisnar, Gábor Mikala, Laura Rosiñol, Anna Marina Liberati, Argiris Symeonidis, Victoria Moody, Marcus Thuresson, Catriona Byrne, Johan Harmenberg, Nicolaas A Bakker, Roman Hájek, Maria-Victoria Mateos, Paul G Richardson, Pieter Sonneveld, Fredrik Schjesvold, Anna Nikolayeva, Waldemar Tomczak, Ludek Pour, Ivan Spicka, Gabor Mikala, Laura Rosinol, Tatiana Konstantinova, Anargyros Symeonidis, Moshe Gatt, Arpad Illes, Haifaa Abdulhaq, Moez Dungarwalla, Sebastian Grosicki, Roman Hajek, Xavier Leleu, Alexander Myasnikov, Paul G. Richardson, Irit Avivi, Dries Deeren, Mercedes Gironella, Miguel Teodoro Hernandez-Garcia, Joaquin Martinez Lopez, Muriel Newinger-Porte, Paz Ribas, Olga Samoilova, Eric Voog, Mario Arnao-Herraiz, Estrella Carrillo-Cruz, Paolo Corradini, Jyothi Dodlapati, Miquel Granell Gorrochategui, Shang-Yi Huang, Matthew Jenner, Lionel Karlin, Jin Seok Kim, Agnieszka Kopacz, Nadezhda Medvedeva, Chang-Ki Min, Roberto Mina, Katrin Palk, Ho-Jin Shin, Sang Kyun Sohn, Jason Tache, Achilles Anagnostopoulos, Jose-Maria Arguiñano, Michele Cavo, Joanne Filicko, Margaret Garnes, Janusz Halka, Kathrin Herzog-Tzarfati, Natalia Ipatova, Kihyun Kim, Maria-Theresa Krauth, Irina Kryuchkova, Mihaela Cornelia Lazaroiu, Mario Luppi, Andrei Proydakov, Alessandro Rambaldi, Milda Rudzianskiene, Su-Peng Yeh, Maria Magdalena Alcalá-Peña, Adrian Alegre Amor, Hussain Alizadeh, Maurizio Bendandi, Gillian Brearton, Randall Brown, Jim Cavet, Najib Dally, Miklos Egyed, José Ángel Hernández-Rivas, Ain Kaare, Jean-Michel Karsenti, Janusz Kloczko, William Kreisle, Je-Jung Lee, Sigrid Machherndl-Spandl, Sudhir Manda, Ivan Moiseev, Jan Moreb, Zsolt Nagy, Santosh Nair, Albert Oriol-Rocafiguera, Michael Osswald, Paula Otero-Rodriguez, Valdas Peceliunas, Torben Plesner, Philippe Rey, Giuseppe Rossi, Don Stevens, Celia Suriu, Corrado Tarella, Anke Verlinden, Alain Zannetti, Hematology, and Oncopeptides
Subjects: Published Online, See Comment page e82, Malignancies, University of, Department of Hematology, Hematology
Abstract: Background Melphalan flufenamide (melflufen), an alkylating peptide-drug conjugate, plus dexamethasone showed clinical activity and manageable safety in the phase 2 HORIZON study. We aimed to determine whether melflufen plus dexamethasone would provide a progression-free survival benefit compared with pomalidomide plus dexamethasone in patients with previously treated multiple myeloma. Methods In this randomised, open-label, head-to-head, phase 3 study (OCEAN), adult patients (aged ≥18 years) were recruited from 108 university hospitals, specialist hospitals, and community-based centres in 21 countries across Europe, North America, and Asia. Eligible patients had an ECOG performance status of 0–2; must have had relapsed or refractory multiple myeloma, refractory to lenalidomide (within 18 months of randomisation) and to the last line of therapy; and have received two to four previous lines of therapy (including lenalidomide and a proteasome inhibitor). Patients were randomly assigned (1:1), stratified by age, number of previous lines of therapy, and International Staging System score, to either 28-day cycles of melflufen and dexamethasone (melflufen group) or pomalidomide and dexamethasone (pomalidomide group). All patients received dexamethasone 40 mg orally on days 1, 8, 15, and 22 of each cycle. In the melflufen group, patients received melflufen 40 mg intravenously over 30 min on day 1 of each cycle and in the pomalidomide group, patients received pomalidomide 4 mg orally daily on days 1 to 21 of each cycle. The primary endpoint was progression-free survival assessed by an independent review committee in the intention-to-treat (ITT) population. Safety was assessed in patients who received at least one dose of study medication. This study is registered with ClinicalTrials.gov, NCT03151811, and is ongoing. Findings Between June 12, 2017, and Sept 3, 2020, 246 patients were randomly assigned to the melflufen group (median age 68 years [IQR 60–72]; 107 [43%] were female) and 249 to the pomalidomide group (median age 68 years [IQR 61–72]; 109 [44%] were female). 474 patients received at least one dose of study drug (melflufen group n=228; pomalidomide group n=246; safety population). Data cutoff was Feb 3, 2021. Median progression-free survival was 6·8 months (95% CI 5·0–8·5; 165 [67%] of 246 patients had an event) in the melflufen group and 4·9 months (4·2–5·7; 190 [76%] of 249 patients had an event) in the pomalidomide group (hazard ratio [HR] 0·79, [95% CI 0·64–0·98]; p=0·032), at a median follow-up of 15·5 months (IQR 9·4–22·8) in the melflufen group and 16·3 months (10·1–23·2) in the pomalidomide group. Median overall survival was 19·8 months (95% CI 15·1–25·6) at a median follow-up of 19·8 months (IQR 12·0–25·0) in the melflufen group and 25·0 months (95% CI 18·1–31·9) in the pomalidomide group at a median follow-up of 18·6 months (IQR 11·8–23·7; HR 1·10 [95% CI 0·85–1·44]; p=0·47). The most common grade 3 or 4 treatment-emergent adverse events were thrombocytopenia (143 [63%] of 228 in the melflufen group vs 26 [11%] of 246 in the pomalidomide group), neutropenia (123 [54%] vs 102 [41%]), and anaemia (97 [43%] vs 44 [18%]). Serious treatment-emergent adverse events occurred in 95 (42%) patients in the melflufen group and 113 (46%) in the pomalidomide group, the most common of which were pneumonia (13 [6%] vs 21 [9%]), COVID-19 pneumonia (11 [5%] vs nine [4%]), and thrombocytopenia (nine [4%] vs three [1%]). 27 [12%] patients in the melflufen group and 32 [13%] in the pomalidomide group had fatal treatment-emergent adverse events. Fatal treatment-emergent adverse events were considered possibly treatment related in two patients in the melflufen group (one with acute myeloid leukaemia, one with pancytopenia and acute cardiac failure) and four patients in the pomalidomide group (two patients with pneumonia, one with myelodysplastic syndromes, one with COVID-19 pneumonia). Interpretation Melflufen plus dexamethasone showed superior progression-free survival than pomalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma., Oncopeptides AB
Published: 2022
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25. Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial

Author: Meletios A. Dimopoulos, Fredrik Schjesvold, Vadim Doronin, Olga Vinogradova, Hang Quach, Xavier Leleu, Yolanda Gonzalez Montes, Karthik Ramasamy, Alessandra Pompa, Mark-David Levin, Cindy Lee, Ulf Henrik Mellqvist, Roland Fenk, Hélène Demarquette, Hamdi Sati, Alexander Vorog, Richard Labotka, Jichang Du, Mohamed Darif, and Shaji Kumar
Subjects: Boron Compounds, Male, Disease-free survival, Glycine, Administration, Oral, Myeloma, Article, Phase II trials, Dexamethasone, Antineoplastic Combined Chemotherapy Protocols, Humans, Lenalidomide, RC254-282, Aged, Aged, 80 and over, Adverse effects, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Hematology, Middle Aged, Progression-Free Survival, Thalidomide, Combination drug therapy, Oncology, Female, Multiple Myeloma, Proteasome Inhibitors
Abstract: Multiple myeloma (MM) patients typically receive several lines of combination therapy and first-line treatment commonly includes lenalidomide. As patients age, they become less tolerant to treatment, requiring convenient/tolerable/lenalidomide-free options. Carfilzomib and/or bortezomib-exposed/intolerant, lenalidomide-refractory MM patients with ≥2 prior lines of therapy were randomized 3:2 to ixazomib-dexamethasone (ixa-dex) (n = 73) or pomalidomide-dexamethasone (pom-dex) (n = 49) until progression/toxicity. Median progression-free survival (mPFS) was 7.1 vs 4.8 months with ixa-dex vs pom-dex (HR 0.847, 95% CI 0.535–1.341, P = 0.477; median follow-up: 15.3 vs 17.3 months); there was no statistically significant difference between arms. In patients with 2 and ≥3 prior lines of therapy, respectively, mPFS was 11.0 vs 5.7 months (HR 1.083, 95% CI 0.547–2.144) and 5.7 vs 3.7 months (HR 0.686, 95% CI 0.368–1.279). Among ixa-dex vs pom-dex patients, 69% vs 81% had Grade ≥3 treatment-emergent adverse events (TEAEs), 51% vs 53% had serious TEAEs, 39% vs 36% had TEAEs leading to drug discontinuation, 44% vs 32% had TEAEs leading to dose reduction, and 13% vs 13% died on study. Quality of life was similar between arms and maintained during treatment. Ixa-dex represents an important lenalidomide-free, oral option for this heavily pretreated, lenalidomide-refractory, proteasome inhibitor-exposed population.Trial registration: ClinicalTrials.gov number, NCT03170882.
Published: 2022

26. Pomalidomide and dexamethasone until progression after first salvage therapy in multiple myeloma

Author: Laurent Garderet, Frederique Kuhnowski, Benoit Berge, Murielle Roussel, Laure Devlamynck, Marie Odile Petillon, Martine Escoffre‐Barbe, Ingrid Lafon, Thierry Facon, Xavier Leleu, Lionel Karlin, Aurore Perrot, Anne‐Marie Stoppa, Bruno Royer, Carine Chaleteix, Mourad Tiab, Carla Araujo, Pascal Lenain, Margaret Macro, Karim Belhadj, Souhila Ikhlef, Cyrille Hulin, Herve Avet Loiseau, Michel Attal, and Philippe Moreau
Subjects: Hematology
Published: 2023
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27. Clinical characteristics and outcome of 318 families with familial monoclonal gammopathy: A multicenter Intergroupe Francophone du Myélome study

Author: Charles Dumontet, Delphine Demangel, Perrine Galia, Lionel Karlin, Laurent Roche, Mathieu Fauvernier, Camille Golfier, Marie‐Charlotte Laude, Xavier Leleu, Philippe Rodon, Murielle Roussel, Isabelle Azaïs, Chantal Doyen, Borhane Slama, Salomon Manier, Olivier Decaux, Maroulio Pertesi, Marie Beaumont, Denis Caillot, Eileen M. Boyle, Manuel Cliquennois, Pascale Cony‐Makhoul, Anne‐Violaine Doncker, Véronique Dorvaux, Marie Odile Petillon, Jean Fontan, Bénédicte Hivert, Isabelle Leduc, Cécile Leyronnas, Margaret Macro, Michel Maigre, Clara Mariette, Philippe Mineur, Sophie Rigaudeau, Bruno Royer, Laure Vincent, James Mckay, Emeline Perrial, Laurent Garderet, Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hospices Civils de Lyon (HCL), Microenvironment and B-cells: Immunopathology,Cell Differentiation, and Cancer (MOBIDIC), Université de Rennes (UR)-Etablissement français du sang [Rennes] (EFS Bretagne)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Fédération Française pour la Recherche contre le Myélome et les Gammapathies (FFRMG) Institut National Du Cancer, UCL - SSS/IREC/MONT - Pôle Mont Godinne, and UCL - (MGD) Service d'hématologie
Subjects: Chromosome Aberrations, MESH: Humans, Paraproteinemias, MESH: Multiple Myeloma, [SDV.CAN]Life Sciences [q-bio]/Cancer, Hematology, Prognosis, Monoclonal Gammopathy of Undetermined Significance, MESH: Prognosis, MESH: Paraproteinemias, MESH: Child, MESH: Monoclonal Gammopathy of Undetermined Significance, Humans, MESH: Chromosome Aberrations, Child, Multiple Myeloma
Abstract: International audience; Familial forms of monoclonal gammopathy, defined as multiple myeloma (MM) or Monoclonal Gammopathy of Undetermined Significance (MGUS), are relatively infrequent and most series reported in the literature describe a limited number of families. MM rarely occurs in a familial context. MGUS is observed much more commonly, which can in some cases evolve toward full-blown MM. Although recurrent cytogenetic abnormalities have been described in tumor cells of sporadic cases of MM, the pathogenesis of familial MM remains largely unexplained. In order to identify genetic factors predisposing to familial monoclonal gammopathy, the Intergroupe Francophone du Myélome identified 318 families with at least two confirmed cases of monoclonal gammopathy. There were 169 families with parent/child pairs and 164 families with cases in at least two siblings, compatible with an autosomal transmission. These familial cases were compared with sporadic cases who were matched for age at diagnosis, sex and immunoglobulin isotype, with 10 sporadic cases for each familial case. The gender distribution, age and immunoglobulin subtypes of familial cases were unremarkable in comparison to sporadic cases. With a median follow-up of 7.4 years after diagnosis, the percentage of MGUS cases having evolved to MM was 3%. The median overall survival of the 148 familial MM cases was longer than that of matched sporadic cases, with projected values of 7.6 and 16.1 years in patients older and younger than 65 years, respectively. These data suggest that familial cases of monoclonal gammopathy are similar to sporadic cases in terms of clinical presentation and carry a better prognosis.
Published: 2023
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28. How I Treat Multiple myeloma in the geriatric patient

Author: Thierry Facon, Xavier Leleu, and Salomon Manier
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Abstract: Multiple myeloma (MM) is primarily a disease of elderly patients. Geriatric aspects in the context of MM have been poorly investigated until recently. Treatment outcomes for geriatric patients with MM are often compromised by comorbidities and an enhanced susceptibility to adverse events from therapy. Assessment of patient frailty has become more frequent and will be useful in the context of significant and continuous advances in therapy. The recent emergence of immunotherapy with CD38 monoclonal antibodies and upcoming immuno-oncology drugs, such as bispecific antibodies, will lead to additional therapeutic progress. The applicability of these new molecules to elderly and frail patients is a key clinical question. Here we present 2 patient cases derived from clinical practice. We review current frailty scores and standards of care for elderly newly diagnosed patients with MM, including frail subgroups, and discuss ways to tailor treatment as well as treatment perspectives in this population.
Published: 2023
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29. Integrating biological HLA-DPB1 mismatch models to predict survival after unrelated hematopoietic cell transplantation

Author: Ruggeri, Annalisa, de Wreede, Liesbeth C., Müller, Carlheinz R., Crivello, Pietro, Bonneville, Edouard F., Petersdorf, Effie W., Socié, Gerard, Dubois, Valérie, Niittyvuopio, Riitta, Peräsaari, Juha, Yakoub-Agha, Ibrahim, Cornelissen, Jan J., Wieten, Lotte, Gedde-Dahl, Tobias, Forcade, Edouard, Crawley, Charles R., Marsh, Steven G.E., Gandemer, Virginie, Tholouli, Eleni, Bulabois, Claude-Eric, Huynh, Anne, Choi, Goda, Deconinck, Eric, Itäla-Remes, Maija, Lenhoff, Stig, Bengtsson, Mats, Johansson, Jan-Erik, van Gorkom, Gwendolyn, Hoogenboom, Jorinde D., Vago, Luca, Rocha, Vanderson, Bonini, Chiara, Chabannon, Christian, Fleischhauer, Katharina, Clausen, Johannes, Holter, Wolfgang, Kalhs, Peter, Beguin, Yves, Bron, Dominique, Deeren, Dries, Lung, Wu Ka, Kerre, Tessa, Poiré, Xavier, Selleslag, Dominik, Schroyens, Wilfried, Jindra, Pavel, Mayer, Jiri, Vydra, Jan, Zák, Pavel, Nielsen, Bendt, Sengeloev, Henrik, Kaare, Ain, Partanen, Anu, Bay, Jacques-Olivier, Bertrand, Yves, Blaise, Didier, Bourhis, Jean Henri, Chevallier, Patrice, Cluzeau, Thomas, Damaj, Gandhi, Fegueux, Nathalie, Guyotat, Denis, Hunault-Berger, Mathilde, Labussière-Wallet, Hélène, Leleu, Xavier, Lioure, Bruno, Maury, Sebastien, Michel, Gérard, Mohty, Mohamad, Rubio, Marie Thérèse, Tilly, Herve, Turlure, Pascal, Bethge, Wolfgang, Casper, Jochen, Einsele, Hermann, Ganser, Arnold, Kröger, Nicolaus, Martin, Sonja, Platzbecker, Uwe, Reinhardt, Christian, Schäfer-Eckart, Kerstin, Thurner, Lorenz, Valerius, Thomas, Wulf, Gerald G., Karakasis, Dimitrios, Spyridonidis, Alexandros, Hauser, Peter, Reményi, Péter, Reykdal, Sigrun, Mousavi, Ashrafsadat, Angelucci, Emanuele, Arcese, William, Benedetti, Fabio, Bernasconi, Paolo, Biondi, Andrea, Bonifazi, Francesca, Carella, Angelo Michele, Carluccio, Paola, Casini, Marco, Cavanna, Luigi, Ciceri, Fabio, Cimino, Giuseppe, Corradini, Paolo, Fanin, Renato, Galieni, Piero, Grillo, Giovanni, Iori, Anna Paola, La Nasa, Giorgio, Locatelli, Franco, Marotta, Giuseppe, Martino, Massimo, Mazza, Patrizio, Mordini, Nicola, Musso, Maurizio, Olivieri, Attilio, Pavone, Vincenzo, Pane, Fabrizio, Petrini, Mario, Pioltelli, Pietro, Rambaldi, Alessandro, Ruggeri, Marco, Saccardi, Riccardo, Santarone, Stella, Scimè, Rosanna, Sica, Simona, Tarella, Corrado, Velardi, Andrea, Visani, Giuseppe, Zecca, Marco, Tanase, Alina, Kulagin, Aleksandr, Savchenko, Valery, López, Carmen Albo, Amor, Adrián Alegre, López, Jose Luis Bello, Caballero, Dolores, Duarte, Rafael, Cascon, Maria Jesús Pascual, Porras, Rocio Parody, Pérez-Simón, Jose Antonio, Rovira, Montserrat, Sanz, Jaime, Carrete, Juan Pio Torres, Cammenga, Jörg, Isaksson, Cecilia, Mielke, Stephan, Chalandon, Yves, Passweg, Jakob, Schanz, Urs, Meijer, Ellen, Kuball, Jürgen, Veelken, Joan Hendrik, Apperley, Jane, Bloor, Adrian, Byrne, Jenny, Carpenter, Ben, Clark, Andrew, Collin, Matthew, Craddock, Charles, Gibson, Brenda E., Khan, Anjum, Martin, Murray, Medd, Patrick, Nicholson, Emma, Orchard, Kim, Patel, Amit, Peniket, Andy, Potter, Victoria, Snowden, John, Wilson, Keith M.O., RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Transplant. Immunology/Tissue Typing lab, Interne Geneeskunde, MUMC+: MA Hematologie (9), Hematology, IRCCS San Raffaele Scientific Institute [Milan, Italie], EFS, CHU Lille, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], Oslo University Hospital [Oslo], CHU Bordeaux [Bordeaux], CHU Pontchaillou [Rennes], Institut de Génétique et Développement de Rennes (IGDR), Université de Rennes (UR)-Centre National de la Recherche Scientifique (CNRS)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), University of Groningen [Groningen], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), and Essen University Hospital
Subjects: Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, [SDV]Life Sciences [q-bio], HSCT, Medizin, Hematology, Hematologi
Abstract: International audience; Not available.
Published: 2023
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30. Retreatment of Patients with Anti CD38-Based Combinations in Multiple Myeloma in Real-Life: Results from the Emmy Cohort Study

Author: Cyrille Hulin, Aurore Perrot, Margaret Macro, Anne Vekhoff, Xavier Leleu, Lionel Karlin, Salomon Manier, Laure Vincent, Abderrazak El Yamani, Wajed Abarah, Régis Kaphan, Charles Zarnitsky, Daniel Re, Laure Christophe, Olivier Fitoussi, Nathalie Texier, Raphael Germain, Marion Willaime, Olivier Decaux, CHU Pessac, Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Grand Hôpital de l'Est Francilien (GHEF), Centre Hospitalier Antibes - Juan-les-Pins, CHU Pontchaillou [Rennes], Microenvironment and B-cells: Immunopathology,Cell Differentiation, and Cancer (MOBIDIC), and Université de Rennes (UR)-Etablissement français du sang [Rennes] (EFS Bretagne)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Immunology, [SDV.CAN]Life Sciences [q-bio]/Cancer, Cell Biology, Hematology, Biochemistry
Abstract: International audience
Published: 2022
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31. Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone with Carfilzomib in Relapsed or Refractory Multiple Myeloma. Iskpd - IFM2018-03

Author: Arthur Bobin, Jerome Lambert, Stéphanie Ragot, Aurore Perrot, Salomon Manier, Lionel Karlin, Denis Caillot, Cyrille Hulin, Lotfi Benboubker, Carla Araujo, Jean Fontan, Thorsten Braun, Clara Mariette, Elodie Scherman, Olivier Decaux, jean Sebastien Blade, Faida Keddar, Christophe Roul, Mamoun Dib, Jill Corre, Frederique Orsini, Laure Vincent, Mohamad Mohty, Cyrille Touzeau, Philippe Moreau, Herve Avet Loiseau, Xavier Leleu, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hospices Civils de Lyon (HCL), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre Hospitalier Universitaire [Grenoble] (CHU), Microenvironment and B-cells: Immunopathology,Cell Differentiation, and Cancer (MOBIDIC), Université de Rennes (UR)-Etablissement français du sang [Rennes] (EFS Bretagne)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre Hospitalier Universitaire d'Angers (CHU Angers), and PRES Université Nantes Angers Le Mans (UNAM)
Subjects: Immunology, [SDV.CAN]Life Sciences [q-bio]/Cancer, Cell Biology, Hematology, Biochemistry
Published: 2022
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32. Isatuximab Plus Pomalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma in Real-Life Context in France: IMAGE Subgroup Analysis Based on Prior Lines of Therapy and Refractory Status

Author: Olivier Decaux, Radhia Lafore, Daniel Iaquinta, Christina Tekle, Xavier Leleu, Microenvironment and B-cells: Immunopathology,Cell Differentiation, and Cancer (MOBIDIC), Université de Rennes (UR)-Etablissement français du sang [Rennes] (EFS Bretagne)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Sanofi Gentilly (Sanofi Gentilly), Sanofi US, CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Sanofi
Subjects: Immunology, [SDV.CAN]Life Sciences [q-bio]/Cancer, Cell Biology, Hematology, Biochemistry
Abstract: International audience
Published: 2022
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33. Hodgkin lymphoma and female fertility: a multicenter study in women treated with ABVD

Author: Antoine Machet, Caroline Poudou, Cécile Tomowiak, Thomas Gastinne, Martine Micheline Gardembas, Thomas Systchenko, Niels Moya, Céline Debiais, Anthony Levy, Cécile Gruchet, Florence Sabirou, Stéphanie Noel, Sabrina Bouyer, Xavier Leleu, Vincent Delwail, and Stéphanie Guidez
Subjects: Hematology
Abstract: Preservation of fertility has become a growing concern in young females with Hodgkin lymphoma (HL). However, the rate of pregnancy after the current most frequently prescribed ABVD chemotherapy for HL has rarely been studied. We aimed to determine the impact of ABVD on the fertility of women treated for HL. A non-interventional, multicentric study of female patients of child-bearing age with HL treated. Two healthy apparied women non exposed at chemotherapy (our controls) were assigned for each patient. Fertility was assessed by the number of pregnancies and births after HL treatment. Sixty-seven patients were included. The median age at diagnosis was 24.4 years (16-43). Hodgkin lymphoma was localized disease for 68.7%. 53.7% of all the patients started at least one pregnancy after treatment versus 54.5% of the controls (p=0.92). 81% of patients who desired children had at least one pregnancy. Patients treated with ABVD did not have a longer median time to pregnancy (4.8 years in the group of patients and 6.8 years for controls). Across patients, there has been 58 pregnancies and 48 births (ratio 1.2) and for control cohort, 136 pregnancies and 104 births (ratio 1.3). No increase in obstetric or neonatal complications has been reported in HL in our study. The number of pregnancies, births and the time to start a pregnancy in young women treated with ABVD for HL is not different to that of controls. Therefore, female with HL and treated by ABVD should be reassured in regards to fertility.
Published: 2022
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34. Role of HLA-B exon 1 in graft-versus-host disease after unrelated haemopoietic cell transplantation: a retrospective cohort study

Author: Effie W Petersdorf, Mary Carrington, Colm O'hUigin, Mats Bengtsson, Dianne De Santis, Valerie Dubois, Ted Gooley, Mary Horowitz, Katharine Hsu, J Alejandro Madrigal, Martin J Maiers, Mari Malkki, Caroline McKallor, Yasuo Morishima, Machteld Oudshoorn, Stephen R Spellman, Jean Villard, Phil Stevenson, Martin Maiers, Stephen Spellman, Jane Apperley, Peter Bardy, Ghislaine Bernard, Yves Bertrand, Adrian Bloor, Chiara Bonini, Stephane Buhler, Laura Bungener, Helen Campbell, Kristina Carlson, Ben Carpenter, Anne Cesbron, Christian Chabannon, Yves Chalandon, Jeremy Chapman, Réda Chebel, Patrice Chevallier, Gerda Choi, Matt Collin, Jan J Cornelissen, Charles Crawley, Lloyd D'Orsogna, Jean-Hugues Dalle, Eric Deconinck, Muriel DeMatteis, Mary Diviney, Anne Dormoy, Katia Gagne, Brenda Gibson, Maria Gilleece, David Gottlieb, John Gribben, Tayfun Güngör, Mike Haagenson, Cathie Hart, Rhonda Holdsworth, Ian Humphreys, Yoshihisa Kodera, Mickey Koh, Hélène Labussière-Wallet, Arjan C Lankester, Neubery Lardy, Sarah Lawson, Xavier Leleu, Stephen MacKinnon, Ram Malladi, Steven GE Marsh, Murray Martin, Neema P Mayor, I Grant McQuaker, Ellen Meijer, Satoko Morishima, Emmanouil Nikolousis, Kim Orchard, Jacob Passweg, Amit Patel, Katherine Patrick, Béatrice Pedron, Andy Peniket, Julia Perry, Eefke Petersen, Victoria Potter, Mike Potter, Rachel Protheroe, Nicole Raus, Carmen Ruiz de Elvira, Nigel Russell, Nicholaas PM Schaap, Urs Schanz, Harry Schouten, Roderick Skinner, John Snowden, Eric Spierings, Colin Steward, Eleni Tholouli, Alycia Thornton, Marcel Tilanus, Arnold van de Meer, Hendrik Veelkens, Paul Veys, Narelle Watson, Lyanne Weston, Keith Wilson, Marie Wilson, Robert Wynn, József Zsiros, University of Washington [Seattle], Harvard University [Cambridge], Frederick National Laboratory for Cancer Research (FNLCR), Uppsala Universitet [Uppsala], PathWest Murdoch / Fiona Stanley Hospital [Perth, WA, Australia] (PMFSH), Etablissement français du sang - Auvergne-Rhône-Alpes (EFS), Fred Hutchinson Cancer Research Center [Seattle] (FHCRC), Medical College of Wisconsin [Milwaukee] (MCW), Memorial Sloane Kettering Cancer Center [New York], Royal Free Hospital [London, UK], Center for International Blood and Marrow Transplant Research [Minneapolis, MN, USA] (CIBMTR), Aichi Medical University School of Medicine [Nagakute, Aichi, Japan] (AMUSM), Leiden University Medical Centre [Leyde, Pays-Bas], Leiden University, Geneva University Hospital (HUG), International Histocompatibility Working Group in Hematopoietic Cell Transplantation: Effie W Petersdorf, Mary Carrington, Colm O'hUigin, Mats Bengtsson, Dianne De Santis, Valerie Dubois, Ted Gooley, Mary Horowitz, Katharine Hsu, J Alejandro Madrigal, Martin Maiers, Mari Malkki, Caroline McKallor, Yasuo Morishima, Machteld Oudshoorn, Stephen Spellman, Jean Villard, Phil Stevenson, Jane Apperley, Peter Bardy, Ghislaine Bernard, Yves Bertrand, Adrian Bloor, Chiara Bonini, Stephane Buhler, Laura Bungener, Helen Campbell, Kristina Carlson, Ben Carpenter, Anne Cesbron, Christian Chabannon, Yves Chalandon, Jeremy Chapman, Réda Chebel, Patrice Chevallier, Gerda Choi, Matt Collin, Jan J Cornelissen, Charles Crawley, Lloyd D'Orsogna, Jean-Hugues Dalle, Eric Deconinck, Muriel DeMatteis, Mary Diviney, Anne Dormoy, Katia Gagne, Brenda Gibson, Maria Gilleece, David Gottlieb, John Gribben, Tayfun Güngör, Mike Haagenson, Cathie Hart, Rhonda Holdsworth, Ian Humphreys, Yoshihisa Kodera, Mickey Koh, Hélène Labussière-Wallet, Arjan C Lankester, Neubery Lardy, Sarah Lawson, Xavier Leleu, Stephen MacKinnon, Ram Malladi, Steven Ge Marsh, Murray Martin, Neema P Mayor, I Grant McQuaker, Ellen Meijer, Satoko Morishima, Emmanouil Nikolousis, Kim Orchard, Jacob Passweg, Amit Patel, Katherine Patrick, Béatrice Pedron, Andy Peniket, Julia Perry, Eefke Petersen, Victoria Potter, Mike Potter, Rachel Protheroe, Nicole Raus, Carmen Ruiz de Elvira, Nigel Russell, Nicholaas Pm Schaap, Urs Schanz, Harry Schouten, Roderick Skinner, John Snowden, Eric Spierings, Colin Steward, Eleni Tholouli, Alycia Thornton, Marcel Tilanus, Arnold van de Meer, Hendrik Veelkens, Paul Veys, Narelle Watson, Lyanne Weston, Keith Wilson, Marie Wilson, Robert Wynn, József Zsiros, Leiden University Medical Center (LUMC), GAGNE, Katia, CCA - Cancer Treatment and quality of life, AII - Inflammatory diseases, Hematology, CCA - Cancer biology and immunology, Petersdorf, E. W., Carrington, M., O'Huigin, C., Bengtsson, M., De Santis, D., Dubois, V., Gooley, T., Horowitz, M., Hsu, K., Madrigal, J. A., Maiers, M. J., Malkki, M., Mckallor, C., Morishima, Y., Oudshoorn, M., Spellman, S. R., Villard, J., Stevenson, P., Maiers, M., Spellman, S., Apperley, J., Bardy, P., Bernard, G., Bertrand, Y., Bloor, A., Bonini, C., Buhler, S., Bungener, L., Campbell, H., Carlson, K., Carpenter, B., Cesbron, A., Chabannon, C., Chalandon, Y., Chapman, J., Chebel, R., Chevallier, P., Choi, G., Collin, M., Cornelissen, J. J., Crawley, C., D'Orsogna, L., Dalle, J. -H., Deconinck, E., Dematteis, M., Diviney, M., Dormoy, A., Gagne, K., Gibson, B., Gilleece, M., Gottlieb, D., Gribben, J., Gungor, T., Haagenson, M., Hart, C., Holdsworth, R., Humphreys, I., Kodera, Y., Koh, M., Labussiere-Wallet, H., Lankester, A. C., Lardy, N., Lawson, S., Leleu, X., Mackinnon, S., Malladi, R., Marsh, S. G., Martin, M., Mayor, N. P., Mcquaker, I. G., Meijer, E., Morishima, S., Nikolousis, E., Orchard, K., Passweg, J., Patel, A., Patrick, K., Pedron, B., Peniket, A., Perry, J., Petersen, E., Potter, V., Potter, M., Protheroe, R., Raus, N., Ruiz de Elvira, C., Russell, N., Schaap, N. P., Schanz, U., Schouten, H., Skinner, R., Snowden, J., Spierings, E., Steward, C., Tholouli, E., Thornton, A., Tilanus, M., van de Meer, A., Veelkens, H., Veys, P., Watson, N., Weston, L., Wilson, K., Wilson, M., Wynn, R., Zsiros, J., RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: DA TI Staf (9), University of Zurich, and Petersdorf, Effie W
Subjects: Oncology, Male, Hematopoietic Stem Cell Transplantation/methods, [SDV]Life Sciences [q-bio], 2720 Hematology, Graft vs Host Disease, Histocompatibility Testing, 0302 clinical medicine, Graft vs Host Disease/genetics, immune system diseases, unrelated donor, Exons/genetics, graft-versus-host disease, Medicine, ddc:616, Hematopoietic Stem Cell Transplantation, Exons, Hematology, Middle Aged, 3. Good health, [SDV] Life Sciences [q-bio], surgical procedures, operative, 030220 oncology & carcinogenesis, Histocompatibility, HLA-B Antigens/genetics, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, EXPRESSION, Adult, medicine.medical_specialty, Adolescent, [SDV.IMM] Life Sciences [q-bio]/Immunology, 610 Medicine & health, Human leukocyte antigen, Lower risk, Risk Assessment, Article, Graft vs Host Disease/genetics/immunology, 03 medical and health sciences, Internal medicine, Journal Article, Humans, Retrospective Studies, RECEPTOR, business.industry, MORTALITY, RECOGNITION, Retrospective cohort study, Odds ratio, medicine.disease, Transplantation, Graft-versus-host disease, hematopoietic-cell transplantation, SEQUENCE-DERIVED PEPTIDES, 10036 Medical Clinic, HLA-B Antigens, 10032 Clinic for Oncology and Hematology, Multivariate Analysis, RESIDUES, HLA-B leader, business, 030215 immunology
Abstract: Background: The success of unrelated haemopoietic cell transplantation (HCT) is limited by graft-versus-host disease (GVHD), which is the main post-transplantation challenge when HLA-matched donors are unavailable. A sequence dimorphism in exon 1 of HLA-B gives rise to leader peptides containing methionine (Met; M) or threonine (Thr; T), which differentially influence natural killer and T-cell alloresponses. The main aim of the study was to evaluate the role of the leader dimorphism in GVHD after HLA-B-mismatched unrelated HCT. Methods: We did a retrospective cohort study of 33 982 patients who received an unrelated HCT done in Australia, Europe, Japan, North America, and the UK between Jan 1, 1988, and Dec 31, 2016. Data were contributed by participants of the International Histocompatibility Working Group in Hematopoietic Cell Transplantation. All cases were included and there were no exclusion criteria. Multivariate regression models were used to assess risks associated with HLA-A, HLA-B, HLA-C, HLA-DRB1, and HLA-DQB1 mismatching. Among the 33 982 transplantations, the risks of GVHD associated with HLA-B M and T leaders were established in 17 100 (50·3%) HLA-matched and 1457 (4·3%) single HLA-B-mismatched transplantations using multivariate regression models. Leader frequencies were defined in 2 004 742 BeTheMatch US registry donors. Findings: Between Jan 20, 2017, and March 11, 2019, we assessed 33 982 HCTs using multivariate regression models for the role of HLA mismatching on outcome. Median follow-up was 1841 days (IQR 909–2963). Mortality and GVHD increased with increasing numbers of HLA mismatches. A single HLA-B mismatch increased grade 3–4 acute GVHD (odds ratio [OR] 1·89, 95% CI 1·53–2·33; p
Published: 2021
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35. Health-related quality of life outcomes from the CANDOR study in patients with relapsed or refractory multiple myeloma

Author: Anita Zahlten-Kumeli, Katja Weisel, Xavier Leleu, David S. Siegel, Bifeng Ding, and Rohan Medhekar
Subjects: Oncology, Cancer Research, medicine.medical_specialty, Dexamethasone, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, In patient, Health related quality of life, Likelihood Functions, business.industry, Daratumumab, Refractory Multiple Myeloma, Hematology, Carfilzomib, chemistry, 030220 oncology & carcinogenesis, Quality of Life, Proteasome inhibitor, Multiple Myeloma, business, 030215 immunology, medicine.drug
Abstract: CANDOR (NCT03158688) compared carfilzomib, dexamethasone, and daratumumab (KdD) to carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM). A secondary objective of CANDOR was to evaluate health-related quality of life (HRQoL) scores using the Global Health Status (GHS)/Quality of Life (QoL) domain of the EORTC QLQ-C30. Scores were compared between KdD and Kd using a restricted maximum likelihood-based mixed effects model for repeated measures. GHS/QoL completion rates were81% for both arms. Higher GHS/QoL scores were observed with KdD versus Kd from Cycle 7-26. The overall least squares mean estimate (95% CI) of the difference between treatment arms was 0.06 (-2.39 to 2.50
Published: 2021
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36. Improved survival in multiple myeloma during the 2005–2009 and 2010–2014 periods

Author: Claudine Sohn, Denis Caillot, Intergroupe Francophone du Myelome, Valentine Richez, Lauriane Clement-Filliatre, Hervé Avet-Loiseau, Lionel Karlin, Karim Belhadj, Philippe Collet, Mourad Tiab, Philippe Moreau, Mamoun Dib, Sabine Brechignac, Jean Fontan, Borane Slama, Cyrille Hulin, François Lifermann, Margaret Macro, Thierry Facon, Mohamad Mohty, Philippe Rey, Hélène Demarquette, Aurore Perrot, Jill Corre, Clara Mariette, Anne-Marie Stoppa, Xavier Leleu, Frédérique Orsini-Piocelle, Laurent Voillat, and Jean-Pierre Marolleau
Subjects: Oncology, Cancer Research, medicine.medical_specialty, business.industry, MEDLINE, Improved survival, Signs and symptoms, Hematology, medicine.disease, Text mining, Internal medicine, medicine, business, Multiple myeloma
Published: 2021
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37. Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US

Author: Hans C. Lee, Saad Z. Usmani, Robert M. Rifkin, Dasha Cherepanov, Evangelos Terpos, Faith E. Davies, Dorothy Romanus, Antonio Palumbo, Aditya Raju, Jesus G. Berdeja, Dawn Marie Stull, Noemi Puig, Jorge Vela-Ojeda, Rafat Abonour, Xavier Leleu, Hui Huang, Ajai Chari, Eileen Farrelly, Mario Boccadoro, Gordon Cook, Katja Weisel, Gareth J. Morgan, Caitlin Costello, Jeffrey A. Zonder, Marlo Blazer, Michael A. Thompson, and Roman Hájek
Subjects: Boron Compounds, Male, Oncology, medicine.medical_specialty, Glycine, Proteasome inhibitor triplet therapy, Ixazomib, Bortezomib, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Daratumumab, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, 030212 general & internal medicine, Lenalidomide, Multiple myeloma, Aged, Retrospective Studies, business.industry, Carfilzomib, Antibodies, Monoclonal, Hematology, General Medicine, Middle Aged, Pomalidomide, medicine.disease, Clinical trial, Treatment Outcome, Real-world, chemistry, 030220 oncology & carcinogenesis, Original Article, Female, Neoplasm Recurrence, Local, Multiple Myeloma, business, Relapsed refractory multiple myeloma, Oligopeptides, medicine.drug
Abstract: Multiple available combinations of proteasome inhibitors, immunomodulators (IMIDs), and monoclonal antibodies are shifting the relapsed/refractory multiple myeloma (RRMM) treatment landscape. Lack of head-to-head trials of triplet regimens highlights the need for real-world (RW) evidence. We conducted an RW comparative effectiveness analysis of bortezomib (V), carfilzomib (K), ixazomib (I), and daratumumab (D) combined with either lenalidomide or pomalidomide plus dexamethasone (Rd or Pd) in RRMM. A retrospective cohort of patients initiating triplet regimens in line of therapy (LOT) ≥ 2 on/after 1/1/2014 was followed between 1/2007 and 3/2018 in Optum’s deidentified US electronic health records database. Time to next treatment (TTNT) was estimated using Kaplan-Meier methods; regimens were compared using covariate-adjusted Cox proportional hazard models. Seven hundred forty-one patients (820 patient LOTs) with an Rd backbone (VRd, n = 349; KRd, n = 218; DRd, n = 99; IRd, n = 154) and 348 patients (392 patient LOTs) with a Pd backbone (VPd, n = 52; KPd, n = 146; DPd, n = 149; IPd, n = 45) in LOTs ≥2 were identified. More patients ≥75 years received IRd (39.6%), IPd (37.8%), and VRd (36.7%) than other triplets. More patients receiving VRd/VPd were in LOT2 vs other triplets. Unadjusted median TTNT in LOT ≥ 2: VRd, 13.9; KRd, 8.7; IRd, 11.4; DRd, not estimable (NE); and VPd, 12.0; KPd, 6.7; IPd, 9.5 months; DPd, NE. In covariate-adjusted analysis, only KRd vs DRd was associated with a significantly higher risk of next LOT initiation/death (HR 1.72; P = 0.0142); no Pd triplet was significantly different vs DPd in LOT ≥ 2. Our data highlight important efficacy/effectiveness gaps between results observed in phase 3 clinical trials and those realized in the RW.
Published: 2021
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38. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab

Author: Ravi Vij, Dorothée Semiond, Aurore Perrot, Claire Brillac, Thomas G. Martin, Djordje Atanackovic, Kathryn P. Corzo, Jeffrey A. Zonder, Sandrine Macé, Cristina Gasparetto, Philippe Moreau, Ludek Pour, Joseph Mikhael, Cyrille Hulin, Qilong Weng, Karim Belhadj-Merzoug, Laure Vincent, Samira Bensfia, Nashat Gabrail, Xavier Leleu, and Ivan Spicka
Subjects: Isatuximab, Oncology, medicine.medical_specialty, business.industry, MEDLINE, Phases of clinical research, Daratumumab, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Hematology, medicine.disease, Text mining, Refractory, Internal medicine, Medicine, In patient, business, Multiple myeloma, RC254-282
Published: 2021

39. Up-front carfilzomib, lenalidomide, and dexamethasone with transplant for patients with multiple myeloma: the IFM KRd final results

Author: Michel Attal, Xavier Leleu, Salomon Manier, Lotfi Benboubker, Clara Mariette, Cécile Sonntag, Karim Belhadj, Denis Caillot, Cyrille Touzeau, Martine Escoffre-Barbe, Benjamin Hebraud, Laurent Garderet, Soraya Wuilleme, Philippe Moreau, Jill Corre, Valérie Lauwers-Cances, Thierry Facon, Jehan Dupuis, and Murielle Roussel
Subjects: Male, medicine.medical_specialty, Neoplasm, Residual, Immunology, Kaplan-Meier Estimate, Biochemistry, Gastroenterology, Dexamethasone, Disease-Free Survival, chemistry.chemical_compound, Internal medicine, medicine, Humans, Adverse effect, Lenalidomide, Multiple myeloma, business.industry, Bortezomib, Hematopoietic Stem Cell Transplantation, Cell Biology, Hematology, Middle Aged, medicine.disease, Combined Modality Therapy, Survival Analysis, Carfilzomib, Minimal residual disease, Transplantation, Treatment Outcome, chemistry, Female, Multiple Myeloma, business, Oligopeptides, medicine.drug
Abstract: Bortezomib, lenalidomide, and dexamethasone plus transplant is a standard of care for eligible patients with multiple myeloma. Because responses can deepen with time, regimens with longer and more potent induction/consolidation phases are needed. In this phase 2 study, patients received eight 28-day cycles of carfilzomib (K) 20/36 mg/m2 (days 1-2, 8-9, 15-16), lenalidomide (R) 25 mg (days 1–21), and dexamethasone (d) 20 mg (days 1-2, 8-9, 15-16, 22-23). All patients proceeded to transplant after 4 cycles and received 1 year of lenalidomide maintenance (10 mg, days 1-21). The primary objective was stringent complete response at the completion of consolidation. Overall, 48 patients were screened and 46 enrolled; 21% had adverse cytogenetics. Among 42 evaluable patients after consolidation, 26 were in stringent complete response (CR; 61.9%), 27 were at least in CR (64.3%): 92.6% had undetectable minimal residual disease according to flow cytometry (≥2.5 × 10−5) and 63.0% according to next-generation sequencing (10−6). Median time to CR was 10.6 months. According to multiparametric flow cytometry and next-generation sequencing, 69.0% and 66.7% of patients, respectively, had undetectable minimal residual disease at some point. With a median follow-up of 60.5 months, 21 patients progressed, and 10 died (7 of multiple myeloma). Median progression-free survival was 56.4 months. There were no KRd-related deaths. Four patients discontinued the program due to toxicities; 56 serious adverse events were reported in 31 patients, including 8 cardiovascular events (2 heart failures, 5 pulmonary embolisms or deep vein thrombosis). Common grade 3/4 adverse events were hematologic (74%) and infectious (22%). In summary, 8 cycles of KRd produce fast and deep responses in transplant-eligible patients with newly diagnosed multiple myeloma. The safety profile is acceptable, but cardiovascular adverse events should be closely monitored. This clinical trial is registered at www.clinicaltrials.gov as #NCT02405364.
Published: 2021
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40. COVID-19 vaccination in patients with multiple myeloma: a consensus of the European Myeloma Network

Author: Heinz Ludwig, Pieter Sonneveld, Thierry Facon, Jesus San-Miguel, Hervé Avet-Loiseau, Mohamad Mohty, Maria-Victoria Mateos, Philippe Moreau, Michele Cavo, Charlotte Pawlyn, Sonja Zweegman, Monika Engelhardt, Christoph Driessen, Gordon Cook, Melitios A Dimopoulos, Francesca Gay, Hermann Einsele, Michel Delforge, Jo Caers, Katja Weisel, Graham Jackson, Laurent Garderet, Niels van de Donk, Xavier Leleu, Hartmut Goldschmidt, Meral Beksac, Inger Nijhof, Martin Schreder, Niels Abildgaard, Roman Hajek, Niklas Zojer, Efstathios Kastritis, Annemiek Broijl, Fredrik Schjesvold, Mario Boccadoro, Evangelos Terpos, Hematology, Ludwig H., Sonneveld P., Facon T., San-Miguel J., Avet-Loiseau H., Mohty M., Mateos M.-V., Moreau P., Cavo M., Pawlyn C., Zweegman S., Engelhardt M., Driessen C., Cook G., Dimopoulos M.A., Gay F., Einsele H., Delforge M., Caers J., Weisel K., Jackson G., Garderet L., van de Donk N., Leleu X., Goldschmidt H., Beksac M., Nijhof I., Schreder M., Abildgaard N., Hajek R., Zojer N., Kastritis E., Broijl A., Schjesvold F., Boccadoro M., Terpos E., and Austrian Forum Against Cancer
Subjects: Oncology, medicine.medical_specialty, COVID-19 Vaccines, Consensus, medicine.drug_class, medicine.medical_treatment, COVID-19 Vaccine, Consensu, Review, Disease, Monoclonal antibody, Immune system, SDG 3 - Good Health and Well-being, Internal medicine, Concomitant Therapy, medicine, Humans, Multiple myeloma, business.industry, SARS-CoV-2, Vaccination, COVID-19, Immunosuppression, Hematology, medicine.disease, Discontinuation, Practice Guidelines as Topic, business, Multiple Myeloma, Human
Abstract: Patients with multiple myeloma frequently present with substantial immune impairment and an increased risk for infections and infection-related mortality. The risk for infection with SARS-CoV-2 virus and resulting mortality is also increased, emphasising the importance of protecting patients by vaccination. Available data in patients with multiple myeloma suggest a suboptimal anti-SARS-CoV-2 immune response, meaning a proportion of patients are unprotected. Factors associated with poor response are uncontrolled disease, immunosuppression, concomitant therapy, more lines of therapy, and CD38 antibody-directed and B-cell maturation antigen-directed therapy. These facts suggest that monitoring the immune response to vaccination in patients with multiple myeloma might provide guidance for clinical management, such as administration of additional doses of the same or another vaccine, or even temporary treatment discontinuation, if possible. In those who do not exhibit a good response, prophylactic treatment with neutralising monoclonal antibody cocktails might be considered. In patients deficient of a SARS-CoV-2 immune response, adherence to measures for infection risk reduction is particularly recommended. This consensus was generated by members of the European Multiple Myeloma Network and some external experts. The panel members convened in virtual meetings and conducted an extensive literature research and evaluated recently published data and work presented at meetings, as well as findings from their own studies. The outcome of the discussions on establishing consensus recommendations for COVID-19, This study has been funded by the Austrian Forum against Cancer, which covered in part expenses for interaction between authors and for secretarial support.
Published: 2021
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41. CPX-351 versus 7+3 dans la leucémie aiguë myéloïde du sujet âgé : avantage en survie globale conservée à cinq ans

Author: Arnaud Saillant, Xavier Leleu, and Niels Moya
Subjects: Hematology
Published: 2021
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42. Denosumab compared with zoledronic acid on PFS in multiple myeloma: exploratory results of an international phase 3 study

Author: Xavier Leleu, Waltraud Pasteiner, Peter I. Croucher, Yang Wang, Evangelos Terpos, Charlotte Pawlyn, Anthony Glennane, Noopur Raje, Jude Canon, and Ramón García-Sanz
Subjects: Oncology, medicine.medical_specialty, Clinical Trials and Observations, Phases of clinical research, Renal function, Transplantation, Autologous, Zoledronic Acid, Autologous stem-cell transplantation, Internal medicine, medicine, Humans, Multiple myeloma, Aged, Bortezomib, business.industry, Hazard ratio, Hematopoietic Stem Cell Transplantation, Hematology, medicine.disease, Progression-Free Survival, Denosumab, Zoledronic acid, Multiple Myeloma, business, medicine.drug
Abstract: An exploratory end point from a recent trial in patients with newly diagnosed multiple myeloma showed that median progression-free survival (PFS) was increased by 10.7 months with denosumab vs zoledronic acid. We performed additional analyses to identify factors that may have contributed to the favorable PFS with denosumab. Ad hoc analyses were performed for patients intending to undergo autologous stem cell transplantation (ASCT; ASCT intent), not intending to undergo ASCT (ASCT no intent), and intent-to-treat according to age (60 mL/min creatinine clearance [CrCl]). Of 1718 patients, 930 (54.1%) were in the ASCT-intent subgroup, and 788 (45.9%) were in the ASCT-no-intent subgroup. In the ASCT-intent subgroup, frontline triplet (median PFS, not estimable vs 35.7 months; hazard ratio [HR] [95% confidence interval (CI)], 0.65 [0.47-0.90]; descriptive P = .009) or bortezomib-only (median PFS, not estimable vs not estimable; HR [95% CI], 0.61 [0.39–0.95]; descriptive P = .029) induction regimens demonstrated the strongest PFS benefit favoring denosumab vs zoledronic acid. In the ASCT-no-intent subgroup, no benefit with denosumab vs zoledronic acid was observed. PFS favored denosumab vs zoledronic acid in patients with CrCl >60 mL/min and in patients
Published: 2021
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43. Total body irradiation + fludarabine compared to busulfan + fludarabine as 'reduced-toxicity conditioning' for patients with acute myeloid leukemia treated with allogeneic hematopoietic cell transplantation in first complete remission: a study by the Acute Leukemia Working Party of the EBMT

Author: Giebel, Sebastian, Labopin, Myriam, Sobczyk-Kruszelnicka, Malgorzata, Stelljes, Matthias, Byrne, Jenny, Fegueux, Nathalie, Beelen, Dietrich, Rovira, Montserrat, Spyridonidis, Alexandros, Blaise, Didier, Bornhäuser, Martin, Karadogan, Ihsan, Savani, Bipin, Nagler, Arnon, Mohty, Mohamad, Martin, Sonja, Chevallier, Patrice, Neubauer, Andreas, Damaj, Gandhi, Koc, Yener, Ganser, Arnold, Collin, Matthew, Yakoub-Agha, Ibrahim, Ozdogu, Hakan, Araujo, Mercedes Colorado, Itäla-Remes, Maija, Orchard, Kim, Isaksson, Cecilia, Bethge, Wolfgang, Martin, Hans, Aljurf, Mahmoud, Faber, Edgar, Caballero, Dolores, Zák, Pavel, Leleu, Xavier, Bay, Jacques-Olivier, Rohrlich, Pierre-Simon, Kröger, Nicolaus, Huynh, Anne, Schäfer-Eckart, Kerstin, Milpied, Noel, Lenhoff, Stig, Ho, Aloysius, López, Jose Luis Bello, Mordini, Nicola, Lioure, Bruno, Halaburda, Kazimierz, Olivieri, Attilio, Gedde-Dahl, Tobias, Protheroe, Rachel, Tischer, Johanna, Klammer, Matthias, Clausen, Johannes, Potter, Victoria, Ladetto, Marco, Tilly, Herve, Deconinck, Eric, Brecht, Arne, Müller, Lutz Peter, Heinicke, Thomas, Carrete, Juan Pio Torres, Bazarbachi, Ali, Reményi, Péter, Rubio, Marie Thérèse, Fanin, Renato, Pérez-Simón, Jose Antonio, Niels, Murawski, Diez-Martin, J., Arat, Mutlu, Hermine, Olivier, Socié, Gerard, Cornelissen, Jan, Santarone, Stella, Guyotat, Denis, Bulabois, Claude Eric, Bernasconi, Paolo, Johansson, Jan-Erik, Vrhovac, Radovan, Greinix, Hildegard, Lorenzo, José Luis López, Apte, Shashikant, Craddock, Charles, Kobbe, Guido, Zahrani, Mohsen Al, Dreger, Peter, Lange, Andrzej, Tbakhi, Abdelghani, Meijer, Ellen, Llamas, Carlos Vallejo, Santasusana, Josep Maria Ribera, Corradini, Paolo, Benedetti, Fabio, Rambaldi, Alessandro, Gandemer, Virginie, Malfuson, Jean-Valère, Kaare, Ain, Risitano, Antonio, Petrini, Mario, Selleri, Carmine, Wu, Depei, Hematology, CCA - Cancer Treatment and quality of life, Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: medicine.medical_specialty, Transplantation Conditioning, MESH: Busulfan, Medizin, MESH: Graft vs Host Disease, Graft vs Host Disease, [SDV.CAN]Life Sciences [q-bio]/Cancer, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Busulfan, MESH: Hematopoietic Stem Cell Transplantation, MESH: Transplantation Conditioning, Retrospective Studies, Transplantation, Acute leukemia, MESH: Humans, MESH: Middle Aged, business.industry, Hazard ratio, Hematopoietic Stem Cell Transplantation, Myeloid leukemia, MESH: Retrospective Studies, Retrospective cohort study, Hematology, Middle Aged, Total body irradiation, Fludarabine, Leukemia, Myeloid, Acute, Regimen, 030220 oncology & carcinogenesis, MESH: Vidarabine, [SDV.IMM]Life Sciences [q-bio]/Immunology, MESH: Leukemia, Myeloid, Acute, business, MESH: Whole-Body Irradiation, Vidarabine, Whole-Body Irradiation, 030215 immunology, medicine.drug
Abstract: International audience; The optimal conditioning for patients with acute myeloid leukemia in first complete remission treated with allogeneic hematopoietic cell transplantation (allo-HCT) has not been defined so far. In this retrospective study, we compared two "reduced-toxicity" regimens: intravenous busulfan at a total dose of 9.6 mg/kg (3 days) + fludarabine (Bu3/Flu) and total body irradiation at a dose of 8 Gy + fludarabine (TBI8Gy/Flu). In the entire study cohort (n = 518), the probabilities of overall survival (OS), leukemia-free survival (LFS), relapse and non-relapse mortality (NRM) at 2 years for Bu3/Flu and TBI8Gy/Flu were 62% vs. 72.5% (p = 0.051), 59.5% vs. 65% (p = 0.15), 30% vs. 20% (p = 0.01), and 10% vs. 14% (p = 0.18), respectively. In multivariate model for patients
Published: 2021
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44. Updated Interim Results from a Phase 1 Study of HPN217, a Half-Life Extended Tri-Specific T Cell Activating Construct (TriTAC®) Targeting B Cell Maturation Antigen (BCMA) for Relapsed/Refractory Multiple Myeloma (RRMM)

Author: Al-Ola Abdallah, Andrew J Cowan, Xavier Leleu, Cyrille Touzeau, Brea Lipe, Eva Medvedova, Caitlin Costello, Jens Hillengass, P. Leif Bergsagel, Raya Mawad, Henning Schade, Daniel Morillo Giles, Albert Oriol, Yifah Yaron, Patrick P Ng, and Sumit Madan
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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45. Conditioning Regimen Intensity and Donor Choice Do Not Impact Outcomes of Patients (pts) with Acute Myeloid Leukemia (AML) after Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) in First Complete Remission (CR1): An EBMT Analysis

Author: Razan Mohty, Myriam Labopin, Jean Henri Bouhris, Ibrahim Yakoub-Agha, Urpu Salmenniemi, Anne Huynh, Eolia Brissot, Didier Blaise, Régis Peffault de Latour, Claude-Eric Bulabois, Eric Deconinck, Jakob Passweg, Edouard Forcade, Hélène Labussière-Wallet, Xavier Leleu, Anne-Lise Menard, Ali Bazarbachi, Arnon Nagler, Fabio Ciceri, and Mohamad Mohty
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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46. Long-Term Outcome of Second Allogeneic Stem Cell Transplantation (HSCT2) for Primary Graft Failure in Patients with Acute Leukemia in Remission: A Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation

Author: Arnon Nagler, Myriam Labopin, Alexander D. Kulagin, Andrea Velardi, Jaime Sanz, Hélène Labussière-Wallet, Victoria Potter, Jurgen Kuball, Simona Sica, Elena N. Parovichnikova, Wolfgang Bethge, Xavier Leleu, Uwe Platzbecker, Friedrich Stölzel, Fabio Ciceri, and Mohamad Mohty
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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47. A Dexamethasone Sparing-Regimen with Daratumumab and Lenalidomide in Frail Patients with Newly-Diagnosed Multiple Myeloma: Efficacy and Safety Analysis of the Phase 3 IFM2017-03 Trial

Author: Salomon Manier, Jill Corre, Cyrille Hulin, Kamel Laribi, Carla Araujo, Gian-Matteo Pica, Cyrille Touzeau, Pascal Godmer, Bohrane Slama, Lionel Karlin, Frederique Orsini-Piocelle, Mamoun Dib, Margaret Macro, Laurence Sanhes, Aurore Perrot, Jean Yves Mary, Jerome Lambert, Herve Avet-Loiseau, Philippe Moreau, Xavier Leleu, and Thierry Facon
Subjects: Immunology, Cell Biology, Hematology, Biochemistry
Published: 2022
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48. A PHASE 2 TRIAL OF ELRANATAMAB, A B-CELL MATURATION ANTIGEN (BCMA)-CD3 BISPECIFIC ANTIBODY, IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) MULTIPLE MYELOMA (MM): INITIAL SAFETY RESULTS FOR MAGNETISMM-3

Author: AM Lesokhin, B Arnulf, R Niesvizky, M Mohty, NJ Bahlis, MH Tomasson, P Rodrguez-Otero, H Quach, NS Raje, S Iida, M Raab, A Czibere, S Sullivan, E Leip, A Viqueira, V Blunk, and X Leleu
Subjects: Immunology and Allergy, Hematology
Published: 2022
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49. Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis

Author: Richard Leblanc, Marie-Laure Risse, Xavier Leleu, Ludek Pour, Chang-Ki Min, Marta Segura, Mehmet Turgut, Sandrine Schwab, Ross I. Baker, Thomas G. Martin, Marcelo Capra, Laure Malinge, Philippe Moreau, Mohamad Mohty, Meletios A. Dimopoulos, University of California [San Francisco] (UCSF), University of California, Centre hospitalier universitaire de Nantes (CHU Nantes), Murdoch University, University Hospital Brno, Catholic University of Korea, CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire d'Hématologie et d'Immunologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Pathologies biliaires, fibrose et cancer du foie [CHU Saint-Antoine], Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hospital Universitario Virgen del Rocío [Sevilla], Ondokuz Mayis University, Hôpital Maisonneuve-Rosemont, Sanofi-Aventis R&D, SANOFI Recherche, Aixial Pharma, University of Athens Medical School [Athens], [Capra, Marcelo] Hosp Mae de Deus, Ctr Integrad Hematol & Oncol, Porto Alegre, RS, Brazil, [Martin, Thomas] Univ Calif San Francisco, Dept Med, San Francisco, CA 94143 USA, [Moreau, Philippe] Univ Nantes, Dept Hematol, Nantes, France, [Baker, Ross] Murdoch Univ, Perth Blood Inst, Perth, WA, Australia, [Pour, Ludek] Univ Hosp Brno, Dept Internal Med Hematol & Oncol, Brno, Czech Republic, [Min, Chang-Ki] Catholic Univ Korea, Catholic Hematol Hosp, Coll Med, Dept Hematol,Seoul St Marys Hosp, Seoul, South Korea, [Min, Chang-Ki] Catholic Univ Korea, Leukemia Res Inst, Coll Med, Seoul St Marys Hosp, Seoul, South Korea, [Leleu, Xavier] CHU, Serv Hematol & Therapie Cellulaire, Poitiers, France, [Leleu, Xavier] CIC INSERM 1402, Poitiers, France, [Mohty, Mohamad] Sorbonne Univ, Dept Hematol, Hop St Antoine, INSERM UMRS 938, Paris, France, [Reinoso Segura, Marta] Hosp Univ Virgen del Rocio, Seville, Spain, [Turgut, Mehmet] Ondokuz Mayis Univ, Dept Hematol, Fac Med, Samsun, Turkey, [LeBlanc, Richard] Univ Montreal, Hop Maisonneuve Rosemont, Montreal, PQ, Canada, [Risse, Marie-Laure] Sanofi Res & Dev, Vitry Sur Seine, France, [Schwab, Sandrine] Sanofi Res & Dev, Vitry Sur Seine, France, [Malinge, Laure] Aixial, Boulogne, France, [Dimopoulos, Meletios] Natl & Kapodistrian Univ Athens, Sch Med, Dept Clin Therapeut, Athens, Greece, and Sanofi
Subjects: Complications, Failure, Biochemistry, Dexamethasone, Bortezomib, chemistry.chemical_compound, 0302 clinical medicine, Reversibility, Antineoplastic Combined Chemotherapy Protocols, Open-label, Renal Insufficiency, Lenalidomide, Multiple myeloma, media_common, Isatuximab, 0303 health sciences, Hematology, 3. Good health, Safety profile, 030220 oncology & carcinogenesis, Multiple Myeloma, Oligopeptides, medicine.drug, medicine.medical_specialty, Phase-iii, Immunology, Urology, Renal function, Subgroup analysis, Antibodies, Monoclonal, Humanized, Pooled analysis, 03 medical and health sciences, Internal medicine, medicine, Humans, media_common.cataloged_instance, In patient, European union, Renal response, Staging system, 030304 developmental biology, Low-dose dexamethasone, business.industry, Cell Biology, medicine.disease, Carfilzomib, chemistry, business, Dialysis, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030215 immunology
Abstract: Introduction: Renal impairment (RI) is a common feature in multiple myeloma (MM) and an adverse predictor of survival. Anti-myeloma treatments that can also improve renal function in patients (pts) with MM are required. Isatuximab (Isa), a monoclonal CD38 antibody, is approved in combination with pomalidomide and dexamethasone (d), in the United States, the European Union, Canada, Australia, Switzerland, and Japan for the treatment of adult pts with relapsed/refractory MM who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. IKEMA (NCT03275285) was a randomized, open-label, multicenter, Phase 3 study that demonstrated the benefit of adding Isa to carfilzomib (K) plus d vs Kd in pts with relapsed MM. This subgroup analysis of IKEMA examined efficacy, renal response, and safety in pts with RI. Methods: Pts with 1-3 prior lines of therapy were randomized 3:2 and stratified by number of prior lines and revised international staging system (R-ISS) stage to receive Isa-Kd or Kd. The Isa-Kd arm received Isa 10 mg/kg intravenously weekly for 4 weeks, then every 2 weeks thereafter. Both arms received recommended doses of Kd. Treatment continued until disease progression or unacceptable adverse events. Interim efficacy analysis was planned when 65% of the total expected progression-free survival (PFS) events determined by an Independent Response Committee were observed. RI was defined as estimated glomerular filtration rate ([eGFR]; using the Modification of Diet in Renal Disease equation) Results: A total of 302 pts (179 Isa-Kd; 123 Kd) were randomized. Pts with baseline eGFR as low as 15 mL/min/1.73m² (severe RI) were allowed to enroll. more pts with RI in the Isa-Kd arm (26.1%) vs Kd (16.2%). As expected, elderly pts had more RI. The median age in years (range) was 67 (39-86) for Isa-Kd vs 69 (49-90) for Kd among RI pts, and 64 (37-81) for Isa-Kd vs 62 (33-78) for Kd among pts with no RI. In RI pts, 60.5% vs 72.2% pts had ≥2 prior lines of therapy, 11.6% vs 16.7% had R-ISS stage III, and 20.9% vs 27.8% had high risk cytogenetics, in Isa-Kd vs Kd, respectively. More RI pts were still on treatment at the cut-off date in Isa-Kd (55.8%) vs Kd (16.7%). Median PFS for RI pts was not reached for Isa-Kd vs 13.4 months for Kd (HR 0.27; 95% CI 0.11-0.66), and not reached for both study arms among pts with no RI (HR 0.63; 95% CI 0.39-1.00). The overall response rate, ≥very good partial response rate, and minimal residual disease negativity for RI pts was higher with Isa-Kd than Kd: 93.0% vs 61.1%, 79.1% vs 44.4%, and 30.2% vs 11.1%, respectively. CrR accessed in pts with eGFR Conclusions: The addition of Isa to Kd improved PFS and disease response in pts with RI, with a manageable safety profile, consistent with the benefit observed in the overall IKEMA study population. Also, more pts treated with Isa-Kd showed reversal of RI and durable renal responses compared with Kd. Finally, RI pts treated with Isa-Kd received twice the number of cycles and had a lower treatment discontinuation rate compared with Kd pts. Disclosures Martin: AMGEN: Research Funding; Sanofi: Research Funding; GSK: Consultancy; Seattle Genetics: Research Funding; Janssen: Research Funding. Moreau:Novartis: Honoraria; Sanofi: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Celgene/Bristol-Myers Squibb: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Takeda: Honoraria. Baker:Sanofi: Research Funding. Leleu:Karyopharm: Honoraria; Sanofi: Honoraria; Novartis: Honoraria; AbbVie: Honoraria; Amgen: Honoraria; Oncopeptide: Honoraria; Incyte: Honoraria; Merck: Honoraria; Carsgen: Honoraria; Janssen: Honoraria; BMS-celgene: Honoraria; GSK: Honoraria. Mohty:Sanofi: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; BMS: Consultancy, Honoraria, Research Funding, Speakers Bureau; GSK: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Stemline: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Jazz Pharmaceuticals: Consultancy, Honoraria, Research Funding, Speakers Bureau. Leblanc:Celgene: Research Funding; Celgene Canada; Janssen Inc.; Amgen Canada; Takeda Canada: Membership on an entity's Board of Directors or advisory committees. Risse:Sanofi: Current Employment. Malinge:AIXIAL: Consultancy. Schwab:Sanofi: Current Employment. Dimopoulos:BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Personal fees, Research Funding, Speakers Bureau.
Published: 2020
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50. R-CHOP appears to be the best first-line treatment for second primary diffuse large B cell lymphoma: a cancer registry study

Author: Pierre Ingrand, Vincent Delwail, A Machet, Stéphanie Guidez, C Debiais-Delpech, Mathieu Puyade, C Laurent, Xavier Leleu, Brigitte Dreyfus, Thomas Systchenko, and Gautier Defossez
Subjects: Oncology, medicine.medical_specialty, Chemotherapy, Multivariate analysis, business.industry, medicine.medical_treatment, Univariate, Hematology, General Medicine, Second primary cancer, medicine.disease, Cancer registry, First line treatment, 03 medical and health sciences, 0302 clinical medicine, immune system diseases, hemic and lymphatic diseases, 030220 oncology & carcinogenesis, Internal medicine, Toxicity, medicine, business, Diffuse large B-cell lymphoma, 030215 immunology
Abstract: Second primary diffuse large B cell lymphoma (spDLBCL) is defined as a metachronous tumor occurring after a first primary cancer. To date, while R-CHOP is the standard first-line treatment for de novo DLBCL, no available data show that R-CHOP is the optimal treatment for spDLBCL. This exploratory study aimed to investigate treatment of spDLBCL. From 2008 to 2015, the Poitou-Charentes general cancer registry recorded 68 cases of spDLBCL ≤ 80 years old, having received a first-line treatment with either R-CHOP (78%) or other regimens (22%). Patients without R-CHOP have worse overall survival in univariate (HR 2.89 [1.33–6.24], P = 0.007) and multivariate (HR 2.98 [1.34–6.67], P = 0.008) analyses. Patients without R-CHOP more frequently had PS > 1 (67% vs. 28%, P = 0.007) and prior chemotherapy (60% vs. 26%, P = 0.02), which suggests that both of these factors influence a clinician’s decision to not use R-CHOP. Prior chemotherapy had no prognostic impact in univariate and multivariate analyses; this result could call into question the risk-benefit balance of not using R-CHOP to prevent toxicity. In our study, one DLBCL out of ten occurred after a first primary cancer, and as regards de novo DLBCL, R-CHOP appeared to be the best first-line treatment. Larger series are needed to confirm these results.
Published: 2020
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