9 results on '"Galli, Monica"'
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2. Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics
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Richardson, Paul G. Schjesvold, Fredrik Weisel, Katja and Moreau, Philippe Anderson, Jr., Larry D. White, Darrell and Rodriguez-Otero, Paula Sonneveld, Pieter Engelhardt, Monika and Jenner, Matthew Corso, Alessandro Duerig, Jan Pavic, Michel and Salomo, Morten Beksac, Meral Oriol, Albert Lindsay, Jindriska Liberati, Anna Marina Galli, Monica Robak, Pawel and Larocca, Alessandra Yagci, Munci Vural, Filiz Kanate, Abraham S. Jiang, Ruiyun Grote, Lara Peluso, Teresa and Dimopoulos, Meletios
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Objective We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse. Methods OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS). Results Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged 65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance
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- 2022
3. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial
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Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesus, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thomas, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, Dimopoulos, Meletios, OPTIMISMM trial investigators, Abildgaard N, Adler H, Altuntas F, Akay OM, Amin B, Anagnostopoulos A, Anderson L, Anttila P, Araujo C, Arce-Lara C, Aydin Y, Basu S, Battini R, Beeker T, Benboubker L, Ben-Yehuda D, Bladé J, Blau IW, Boccia R, Burke L, Byeff P, Cascavilla N, Cavo M, Chantry A, Charles Y, Chaudhry A, Corso A, Coyne M, De Arriba F, Delimpasi S, Desjardins P, Dhakal B, Di Bartolomeo P, Di Raimondo F, Dürig J, Engelhardt M, Escoffre-Barbe M, Esteves G, Flogegard M, Gabrail N, Gamberi B, Garrison M, Gay J, Gisslinger H, Goldschmidt H, Goncalves C, Gressot L, Grosicki S, Hanna W, Hayden P, Henriques Bernardo MM, Hermann R, Holden V, Honkalehto K, Huben M, Huffman J, Hunter H, Hus M, Jagasia M, Jagganath S, Janakiram M, Jaiyesimi I, Jenner M, João C, Johnson P, Jurcyszyn A, Kalayoğlu Beşişik S, Kambhampati S, Kanate A, Karadoğan I, Khojasteh A, Kirkel D, Komarnicki M, Krauth MT, Kuriakose P, Larocca A, Lauri B, Leleu X, Lucio P, Luppi M, Mangiacavalli S, Mariette C, Matsue K, Mellqvist UH, Mendeleeva L, Meshad M, Miller C, Mohrbacher A, Moreau P, Morelli AM, Müldür E, Naassan A, Nahi H, Nair R, O'Dwyer M, Öngören Aydin S, Openshaw T, O'Rourke T, Osswald M, Overton L, Pati A, Pavic M, Pegourie B, Pehlivan M, Pierola AA, Plesner T, Pluta A, Rabin N, Ramasamy K, Rambaldi A, Rodriguez P, Röllig C, Rosenblatt J, Rosenbluth J, Salomo M, Samoylova O, Sastre Moral J, Sati H, Selleri C, Shafeek S, Shinagawa A, Sleckman B, Smith C, Sonmez M, Stone C, Streetly M, Suzuki K, Taetle R, Tafuri A, Takezako N, Teke HÜ, Vapaatalo M, Vassilopoulos G, Verma A, Vidito S, Viterbo L, Vural F, Wang XS, Yağci M, Yee A., Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesu, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thoma, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, Dimopoulos, Meletio, OPTIMISMM trial investigator, Abildgaard N, Adler H, Altuntas F, Akay OM, Amin B, Anagnostopoulos A, Anderson L, Anttila P, Araujo C, Arce-Lara C, Aydin Y, Basu S, Battini R, Beeker T, Benboubker L, Ben-Yehuda D, Bladé J, Blau IW, Boccia R, Burke L, Byeff P, Cascavilla N, Cavo M, Chantry A, Charles Y, Chaudhry A, Corso A, Coyne M, De Arriba F, Delimpasi S, Desjardins P, Dhakal B, Di Bartolomeo P, Di Raimondo F, Dürig J, Engelhardt M, Escoffre-Barbe M, Esteves G, Flogegard M, Gabrail N, Gamberi B, Garrison M, Gay J, Gisslinger H, Goldschmidt H, Goncalves C, Gressot L, Grosicki S, Hanna W, Hayden P, Henriques Bernardo MM, Hermann R, Holden V, Honkalehto K, Huben M, Huffman J, Hunter H, Hus M, Jagasia M, Jagganath S, Janakiram M, Jaiyesimi I, Jenner M, João C, Johnson P, Jurcyszyn A, Kalayoğlu Beşişik S, Kambhampati S, Kanate A, Karadoğan I, Khojasteh A, Kirkel D, Komarnicki M, Krauth MT, Kuriakose P, Larocca A, Lauri B, Leleu X, Lucio P, Luppi M, Mangiacavalli S, Mariette C, Matsue K, Mellqvist UH, Mendeleeva L, Meshad M, Miller C, Mohrbacher A, Moreau P, Morelli AM, Müldür E, Naassan A, Nahi H, Nair R, O'Dwyer M, Öngören Aydin S, Openshaw T, O'Rourke T, Osswald M, Overton L, Pati A, Pavic M, Pegourie B, Pehlivan M, Pierola AA, Plesner T, Pluta A, Rabin N, Ramasamy K, Rambaldi A, Rodriguez P, Röllig C, Rosenblatt J, Rosenbluth J, Salomo M, Samoylova O, Sastre Moral J, Sati H, Selleri C, Shafeek S, Shinagawa A, Sleckman B, Smith C, Sonmez M, Stone C, Streetly M, Suzuki K, Taetle R, Tafuri A, Takezako N, Teke HÜ, Vapaatalo M, Vassilopoulos G, Verma A, Vidito S, Viterbo L, Vural F, Wang XS, Yağci M, Yee A., and Hematology
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Oncology ,Adult ,Male ,medicine.medical_specialty ,Adolescent ,Population ,Dexamethasone ,Bortezomib ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Internal medicine ,hemic and lymphatic diseases ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,education ,Survival rate ,Lenalidomide ,Multiple myeloma ,Aged ,Salvage Therapy ,education.field_of_study ,business.industry ,Pomalidomide, bortezomib, dexamethasone ,Middle Aged ,Pomalidomide ,medicine.disease ,Prognosis ,Thalidomide ,Survival Rate ,Regimen ,Drug Resistance, Neoplasm ,030220 oncology & carcinogenesis ,Female ,Neoplasm Recurrence, Local ,business ,Multiple Myeloma ,030215 immunology ,medicine.drug ,Follow-Up Studies - Abstract
Background As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide. Methods We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged >= 18 years) with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1) to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of beta(2) microglobulin at screening. Bortezomib (1.3 mg/m(2)) was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1,4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years]) was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1-14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled. Findings Between Jan 7, 2013, and May 15,2017,559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15.9 months (IQR 9.9-21.7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11.20 months [95% CI 9.66-13-73] vs 7.10 months [5.88-8-48]; hazard ratio 0.61, 95% CI 0.49-0-77; p
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- 2019
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4. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial
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Richardson, Paul G Oriol, Albert Beksac, Meral Liberati, Anna Marina Galli, Monica Schjesvold, Fredrik Lindsay, Jindriska Weisel, Katja White, Darrell Facon, Thierry others
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Health Sciences ,Επιστήμες Υγείας - Published
- 2019
5. Pomalidomide (POM), bortezomib, and low-dose dexamethasone (PVd) vs bortezomib and low-dose dexamethasone (Vd) in lenalidomide (LEN)-exposed patients (pts) with relapsed or refractory multiple myeloma (RRMM): Phase 3 OPTIMISMM trial
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Richardson, Paul G. Rocafiguera, Albert Oriol Beksac, Meral and Liberati, Anna Marina Galli, Monica Schjesvold, Fredrik and Lindsay, Jindriska Weisel, Katja White, Darell Facon, Thierry San-Miguel, Jesus Sunami, Kazutaka O'Gorman, Peter and Sonneveld, Pieter Yu, Xin Doerr, Thomas Bensmaine, Amine and Zaki, Mohamed H. Anderson, Kenneth Carl Dimopoulos, Meletios A.
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- 2018
6. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 3‐year follow‐up of a multicenter, retrospective clinical experience with 319 cases outside of controlled clinical trials
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Antonella Bruzzese, Daniele Derudas, Monica Galli, Enrica Antonia Martino, Stefano Rocco, Concetta Conticello, Catello Califano, Nicola Giuliani, Silvia Mangiacavalli, Giuliana Farina, Alessandra Lombardo, Marino Brunori, Elena Rossi, Elisabetta Antonioli, Roberto Ria, Renato Zambello, Nicola Di Renzo, Giuseppe Mele, Gianpaolo Marcacci, Giuseppe Pietrantuono, Gaetano Palumbo, Nicola Cascavilla, Claudio Cerchione, Angelo Belotti, Clelia Criscuolo, Giuseppina Uccello, Paola Curci, Ernesto Vigna, Francesco Mendicino, Enrico Iaccino, Selena Mimmi, Cirino Botta, Donatella Vincelli, Nicola Sgherza, Angela Bonalumi, Luca Cupelli, Raffaella Stocchi, Massimo Martino, Stelvio Ballanti, Dominella Gangemi, Alfredo Gagliardi, Barbara Gamberi, Alessandra Pompa, Giovanni Tripepi, Ferdinando Frigeri, Ugo Consoli, Sara Bringhen, Elena Zamagni, Francesca Patriarca, Valerio De Stefano, Francesco Di Raimondo, Salvatore Palmieri, Maria Teresa Petrucci, Massimo Offidani, Pellegrino Musto, Mario Boccadoro, Michele Cavo, Antonino Neri, Fortunato Morabito, Massimo Gentile, Bruzzese, Antonella, Derudas, Daniele, Galli, Monica, Martino, Enrica Antonia, Rocco, Stefano, Conticello, Concetta, Califano, Catello, Giuliani, Nicola, Mangiacavalli, Silvia, Farina, Giuliana, Lombardo, Alessandra, Brunori, Marino, Rossi, Elena, Antonioli, Elisabetta, Ria, Roberto, Zambello, Renato, Di Renzo, Nicola, Mele, Giuseppe, Marcacci, Gianpaolo, Pietrantuono, Giuseppe, Palumbo, Gaetano, Cascavilla, Nicola, Cerchione, Claudio, Belotti, Angelo, Criscuolo, Clelia, Uccello, Giuseppina, Curci, Paola, Vigna, Ernesto, Mendicino, Francesco, Iaccino, Enrico, Mimmi, Selena, Botta, Cirino, Vincelli, Donatella, Sgherza, Nicola, Bonalumi, Angela, Cupelli, Luca, Stocchi, Raffaella, Martino, Massimo, Ballanti, Stelvio, Gangemi, Dominella, Gagliardi, Alfredo, Gamberi, Barbara, Pompa, Alessandra, Tripepi, Giovanni, Frigeri, Ferdinando, Consoli, Ugo, Bringhen, Sara, Zamagni, Elena, Patriarca, Francesca, De Stefano, Valerio, Di Raimondo, Francesco, Palmieri, Salvatore, Petrucci, Maria Teresa, Offidani, Massimo, Musto, Pellegrino, Boccadoro, Mario, Cavo, Michele, Neri, Antonino, Morabito, Fortunato, and Gentile, Massimo
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Cancer Research ,lenalidomide ,dexamethasone ,elotuzumab ,multiple myeloma ,salvage therapy ,Hematology ,General Medicine ,Antibodies, Monoclonal, Humanized ,Thalidomide ,Oncology ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Settore MED/15 - Malattie del Sangue ,Follow-Up Studies ,Retrospective Studies - Abstract
The combination of elotuzumab, lenalidomide, and dexamethasone (EloRd) enhanced the clinical benefit over Rd with a manageable toxicity profile in the ELOQUENT-2 trial, leading to its approval in relapsed/refractory multiple myeloma (RRMM). The present study is a 3-year follow-up update of a previously published Italian real-life RRMM cohort of patients treated with EloRd. This revised analysis entered 319 RRMM patients accrued in 41 Italian centers. After a median follow-up of 36 months (range 6-55), 236 patients experienced disease progression or died. Median progression-free survival (PFS) and overall survival (OS) were 18.4 and 34 months, respectively. The updated multivariate analyses showed a significant reduction of PFS and OS benefit magnitude only in cases with ISS stage III. Major adverse events included grade 3/4 neutropenia (18.5%), anemia (15.4%), lymphocytopenia (12.5%), and thrombocytopenia (10.7%), while infection rates and pneumonia were 33.9% and 18.9%, respectively. No new safety signals with longer follow-up have been observed. Of 319 patients, 245 (76.7%) reached at least a partial remission. A significantly lower response rate was found in patients previously exposed to lenalidomide. In conclusion, our study confirms that EloRd is a safe and effective regimen for RRMM patients, maintaining benefits across multiple unfavorable subgroups. This article is protected by copyright. All rights reserved.
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- 2022
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7. Survival Risk Scores for Real-Life Relapsed/Refractory Multiple Myeloma Patients Receiving Elotuzumab or Carfilzomib In Combination With Lenalidomide and Dexamethasone as Salvage Therapy: Analysis of 919 Cases Outside Clinical Trials
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Fortunato Morabito, Elena Zamagni, Concetta Conticello, Vincenzo Pavone, Salvatore Palmieri, Sara Bringhen, Monica Galli, Silvia Mangiacavalli, Daniele Derudas, Elena Rossi, Roberto Ria, Lucio Catalano, Paola Tacchetti, Giuseppe Mele, Iolanda Donatella Vincelli, Enrica Antonia Martino, Ernesto Vigna, Antonella Bruzzese, Francesco Mendicino, Cirino Botta, Anna Mele, Lucia Pantani, Serena Rocchi, Bruno Garibaldi, Nicola Cascavilla, Stelvio Ballanti, Giovanni Tripepi, Ferdinando Frigeri, Antonetta Pia Falcone, Clotilde Cangialosi, Giovanni Reddiconto, Giuliana Farina, Marialucia Barone, Ilaria Rizzello, Enrico Iaccino, Selena Mimmi, Paola Curci, Barbara Gamberi, Pellegrino Musto, Valerio De Stefano, Maurizio Musso, Maria Teresa Petrucci, Massimo Offidani, Francesco Di Raimondo, Mario Boccadoro, Michele Cavo, Antonino Neri, Massimo Gentile, Morabito, Fortunato, Zamagni, Elena, Conticello, Concetta, Pavone, Vincenzo, Palmieri, Salvatore, Bringhen, Sara, Galli, Monica, Mangiacavalli, Silvia, Derudas, Daniele, Rossi, Elena, Ria, Roberto, Catalano, Lucio, Tacchetti, Paola, Mele, Giuseppe, Vincelli, Iolanda Donatella, Martino, Enrica Antonia, Vigna, Ernesto, Bruzzese, Antonella, Mendicino, Francesco, Botta, Cirino, Mele, Anna, Pantani, Lucia, Rocchi, Serena, Garibaldi, Bruno, Cascavilla, Nicola, Ballanti, Stelvio, Tripepi, Giovanni, Frigeri, Ferdinando, Falcone, Antonetta Pia, Cangialosi, Clotilde, Reddiconto, Giovanni, Farina, Giuliana, Barone, Marialucia, Rizzello, Ilaria, Iaccino, Enrico, Mimmi, Selena, Curci, Paola, Gamberi, Barbara, Musto, Pellegrino, De Stefano, Valerio, Musso, Maurizio, Petrucci, Maria Teresa, Offidani, Massimo, Di Raimondo, Francesco, Boccadoro, Mario, Cavo, Michele, Neri, Antonino, and Gentile, Massimo
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multiple myeloma ,Cancer Research ,carfilzomib ,Oncology ,lenalidomide ,survival ,elotuzumab ,prognosi ,prognostic score ,relapsed/refractory - Abstract
The present study aimed to develop two survival risk scores (RS) for overall survival (OS, SRSKRd/EloRd) and progression-free survival (PFS, PRSKRd/EloRd) in 919 relapsed/refractory multiple myeloma (RRMM) patients who received carfilzomib, lenalidomide, and dexamethasone (KRd)/elotuzumab, lenalidomide, and dexamethasone (EloRd). The median OS was 35.4 months, with no significant difference between the KRd arm versus the EloRd arm. In the multivariate analysis, advanced ISS (HR = 1.31; P = 0.025), interval diagnosis–therapy (HR = 1.46; P = 0.001), number of previous lines of therapies (HR = 1.96; P < 0.0001), older age (HR = 1.72; P < 0.0001), and prior lenalidomide exposure (HR = 1.30; P = 0.026) remained independently associated with death. The median PFS was 20.3 months, with no difference between the two strategies. The multivariate model identified a significant progression/death risk increase for ISS III (HR = 1.37; P = 0.002), >3 previous lines of therapies (HR = 1.67; P < 0.0001), older age (HR = 1.64; P < 0.0001), and prior lenalidomide exposure (HR = 1.35; P = 0.003). Three risk SRSKRd/EloRd categories were generated: low-risk (134 cases, 16.5%), intermediate-risk (467 cases, 57.3%), and high-risk categories (213 cases, 26.2%). The 1- and 2-year OS probability rates were 92.3% and 83.8% for the low-risk (HR = 1, reference category), 81.1% and 60.6% (HR = 2.73; P < 0.0001) for the intermediate-risk, and 65.5% and 42.5% (HR = 4.91; P < 0.0001) for the high-risk groups, respectively. Notably, unlike the low-risk group, which did not cross the median timeline, the OS median values were 36.6 and 18.6 months for the intermediate- and high-risk cases, respectively. Similarly, three PRSKRd/EloRd risk categories were engendered. Based on such grouping, 338 (41.5%) cases were allocated in the low-, 248 (30.5%) in the intermediate-, and 228 (28.0%) in the high-risk groups. The 1- and 2-year PFS probability rates were 71.4% and 54.5% for the low-risk (HR = 1, reference category), 68.9% and 43.7% (HR = 1.95; P < 0.0001) for the intermediate-risk, and 48.0% and 27.1% (HR = 3.73; P < 0.0001) for the high-risk groups, respectively. The PFS median values were 29.0, 21.0, and 11.7 months for the low-, intermediate-, and high-risk cases. This analysis showed 2.7- and 4.9-fold increased risk of death for the intermediate- and high-risk cases treated with KRd/EloRd as salvage therapy. The combined progression/death risks of the two categories were increased 1.3- and 2.2-fold compared to the low-risk group. In conclusion, SRSKRd/EloRd and PRSKRd/EloRd may represent accessible and globally applicable models in daily clinical practice and ultimately represent a prognostic tool for RRMM patients who received KRd or EloRd.
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- 2022
8. Adjusted comparison between elotuzumab and carfilzomib in combination with lenalidomide and dexamethasone as salvage therapy for multiple myeloma patients
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Valerio De Stefano, Lucio Catalano, Lucia Pantani, Pellegrino Musto, Elena Rossi, Enrica Antonia Martino, Antonetta Pia Falcone, Ernesto Vigna, Iolanda Vincelli, Salvatore Palmieri, Paola Tacchetti, Fortunato Morabito, Sara Bringhen, Giovanni Tripepi, Maria Teresa Petrucci, Serena Rocchi, Bruno Garibaldi, Vincenzo Pavone, Francesco Di Raimondo, Giuliana Farina, Nicola Cascavilla, Monica Galli, Antonino Neri, Stelvio Ballanti, Silvia Mangiacavalli, Maurizio Musso, Ilaria Rizzello, Ferdinando Frigeri, Massimo Offidani, Clotilde Cangialosi, Massimo Gentile, Antonella Bruzzese, Elena Zamagni, Anna Mele, Cirino Botta, Mario Boccadoro, Daniele Derudas, Marialucia Barone, Nicola Di Renzo, Concetta Conticello, Giovanni Reddiconto, Roberto Ria, Michele Cavo, Giuseppe Mele, Morabito, Fortunato, Zamagni, Elena, Conticello, Concetta, Pavone, Vincenzo, Palmieri, Salvatore, Bringhen, Sara, Galli, Monica, Mangiacavalli, Silvia, Derudas, Daniele, Rossi, Elena, Ria, Roberto, Catalano, Lucio, Tacchetti, Paola, Mele, Giuseppe, Vincelli, Iolanda Donatella, Martino, Enrica Antonia, Vigna, Ernesto, Botta, Cirino, Bruzzese, Antonella, Mele, Anna, Pantani, Lucia, Rocchi, Serena, Garibaldi, Bruno, Cascavilla, Nicola, Ballanti, Stelvio, Tripepi, Giovanni, Frigeri, Ferdinando, Falcone, Antonetta Pia, Cangialosi, Clotilde, Reddiconto, Giovanni, Farina, Giuliana, Barone, Marialucia, Rizzello, Ilaria, Musto, Pellegrino, De Stefano, Valerio, Musso, Maurizio, Petrucci, Maria Teresa, Offidani, Massimo, Neri, Antonino, Di Renzo, Nicola, Di Raimondo, Francesco, Boccadoro, Mario, Cavo, Michele, and Gentile, Massimo
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Oncology ,medicine.medical_specialty ,Salvage therapy ,Antibodies, Monoclonal, Humanized ,Dexamethasone ,Settore MED/15 - Malattie Del Sangue ,chemistry.chemical_compound ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Elotuzumab ,Lenalidomide ,Multiple myeloma ,Retrospective Studies ,Salvage Therapy ,carfilzomib ,business.industry ,Hazard ratio ,Hematology ,General Medicine ,medicine.disease ,Carfilzomib ,elotuzumab ,multiple myeloma ,chemistry ,Cohort ,business ,Oligopeptides ,medicine.drug - Abstract
The lack of a randomized trial comparing carfilzomib (K) versus elotuzumab (Elo) associated with lenalidomide and dexamethasone (Rd) prompted us to assess the relative usefulness of one triplet over the other. Five independent retrospective cohorts of 883 relapsed/refractory multiple myeloma (RRMM) patients, including 300 EloRd and 583 KRd cases, outside clinical trials, entered this non-randomized comparison. KRd cohort accounted for a higher incidence of younger patients, cases with ≥3 lines of therapy, already exposed to lenalidomide, International Staging System (ISS) stage III, and abnormal lactic dehydrogenase (LDH) level compared with EloRd cohort. Moreover, cytogenetic risk categories, detected in roughly one-third of cases, were equally distributed between the two therapy arms. The probability of CR+VGPR response was significantly higher in KRd (n = 314, 53.9%) than in EloRd patients (n = 111, 37.0%). Likewise, the cumulative incidence function of CR+VGPR, taking into account the competitive risk of death, was significantly higher in KRd arm patients than those in the EloRd arm (p = .003). Moreover, KRd treatment significantly reduced the progression or death risk by 46% in an adjusted multivariate analysis (HR: 0.54, 95% CI 0.42-0.69, p .0001). Finally, in an adjusted illness-progression/death model, the effect of KRd versus EloRd was of higher magnitude among those who achieved CR+VGPR (-39% hazard ratio reduction, p = .02) than among those who achieved VGPR (-29% hazard ratio reduction, p = .007). With limitations characteristic to any retrospective analysis, this current clinical practice study's overall results demonstrated potential benefits of KRd therapy compared with EloRd. This observation may help the daily clinical practice.
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- 2021
9. The timing of plerixafor addition to G-Csf and chemotherapy affects immunological recovery after autologous stem cell transplant in multiple myeloma
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Laura Paris, Francesca Patriarca, Renato Fanin, Monica Galli, Elisa Dan, Andrea Olmo, Beatrice Anna Zannetti, Michele Cavo, Barbara Sinigaglia, Antonio Curti, Simonetta Rizzi, Giulia Tolomelli, Roberto M. Lemoli, Francesca Bonifazi, Valeria Giudice, Maria Rosa Motta, Paola Tacchetti, Mario Arpinati, Lucia Pantani, Russell E. Lewis, Gabriella Chirumbolo, Katia Mancuso, Tolomelli, Giulia, Mancuso, Katia, Tacchetti, Paola, Patriarca, Francesca, Galli, Monica, Pantani, Lucia, Zannetti, Beatrice, Motta, Maria Rosa, Rizzi, Simonetta, Dan, Elisa, Sinigaglia, Barbara, Giudice, Valeria, Olmo, Andrea, Arpinati, Mario, Chirumbolo, Gabriella, Fanin, Renato, Lewis, Russell E, Paris, Laura, Bonifazi, Francesca, Cavo, Michele, Curti, Antonio, and Lemoli, Roberto M
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Benzylamines ,CD34 ,Pharmacology ,CD38 ,Cyclams ,Transplantation, Autologous ,CXCR4 ,03 medical and health sciences ,0302 clinical medicine ,Autologous stem-cell transplantation ,Heterocyclic Compounds ,Granulocyte Colony-Stimulating Factor ,medicine ,Humans ,Progenitor cell ,Multiple myeloma ,plerixafor G-Csf chemotherapy immunological recovery after autologous stem cell transplant multiple myeloma ,Transplantation ,business.industry ,Plerixafor ,Hematopoietic Stem Cell Transplantation ,Hematology ,medicine.disease ,Hematopoietic Stem Cell Mobilization ,030220 oncology & carcinogenesis ,Stem cell ,Multiple Myeloma ,business ,030215 immunology ,medicine.drug - Abstract
Plerixafor inhibits CXCR4, thus inducing the mobilization of hematopoietic stem/progenitor cells in lymphoma and multiple myeloma (MM) patients eligible for autologous stem cell transplantation (ASCT). However, the kinetics of plerixafor-induced mobilization of lymphocyte subsets is poorly known. Here, we evaluated the graft content, the engraftment, and the immunological reconstitution of MM patients receiving plerixafor. Thirty-seven patients undergoing one or tandem ASCT were enrolled. After mobilization with cyclophosphamide plus G-CSF, plerixafor was added at hematological recovery regardless of CD34(+) cell count. We evaluated the number of CD34(+), CD34(+)/CD38(-), CD3(+), CD4(+), CD8(+), CD19(+), CD56(+)/CD3(-), CD4(+)/CD25(+)/FOXP3(+), and CD138(+)/CD38(+) cells on each apheresis. Hematological and immunological recovery were determined at 30 days, 3, 6, 9, and 12 months after ASCT. Overall, 34/37 patients mobilized a median of 10.1 × 10(6) CD34(+) cells/Kg (IQ 7.7-13.4). Patients with
- Published
- 2019
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