53 results on '"Gay, Francesca"'
Search Results
2. Multiple myeloma with t(11;14): unique biology and evolving landscape
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Bal, Susan, Kumar, Shaji K, Fonseca, Rafael, Gay, Francesca, Hungria, Vania Tm, Dogan, Ahmet, and Costa, Luciano J
- Subjects
Multiple myeloma ,BCL-2 ,14) ,prognosis ,t(11 ,Review Article ,targeted therapy - Abstract
Multiple myeloma is characterized by heterogeneity in clinical presentation, response to treatment, and importantly, patient outcomes. The translocation of chromosomes 11 and 14 [t(11;14)(q13;32)], hereafter referred to as t(11;14), is the most common primary translocation event in multiple myeloma, occurring in approximately 16%-24% of patients. Multiple myeloma harboring t(11;14) represents a unique disease subset as t(11;14)-positive myeloma cells exhibit biological features that are distinct from t(11;14)-negative myeloma cells, including overexpression of cyclin D1, higher levels of the antiapoptotic protein BCL-2, and the frequent expression of the B-cell lineage protein CD20. Additionally, t(11;14) is associated with less common clinical features, such as immunoglobulin M and light chain disease. With the evolution of the treatment landscape, the prognostic significance of t(11;14) multiple myeloma remains debatable. However, it is clear that t(11;14) multiple myeloma represents a distinct subset and a rare opportunity for targeted therapy with BCL-2 inhibition. In this review, we first describe the underlying biology of t(11;14) multiple myeloma cells, then summarize the body of literature evaluating the prognosis of patients with t(11;14) multiple myeloma, and finally discuss therapeutic implications.
- Published
- 2022
3. Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma
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Sonneveld, Pieter Dimopoulos, Meletios A. Beksac, Meral van der Holt, Bronno Aquino, Sara Ludwig, Heinz Zweegman, Sonja and Zander, Thilo Zamagni, Elena Wester, Ruth Hajek, Roman and Pantani, Lucia Dozza, Luca Gay, Francesca Cafro, AnneMaria De Rosa, Luca Morelli, Annamaria Gregersen, Henrik and Gulbrandsen, Nina Cornelisse, Petra Troia, Rosella and Oliva, Stefania van de Velden, Vincent Wu, KaLung Ypma, Paula F. Bos, Gerard Levin, Mark-David Pour, Luca and Driessen, Christoph Broijl, Annemiek Croockewit, Alexandra and Minnema, Monique C. Waage, Anders Hveding, Cecilie van de Donk, Niels W. C. J. Offidani, Massimo Palumbo, Giuseppe A. and Spencer, Andrew Boccadoro, Mario Cavo, Michele
- Abstract
PURPOSE To address the role of consolidation treatment for newly diagnosed, transplant eligible patients with multiple myeloma in a controlled clinical trial. PATIENTS AND METHODS The EMN02/HOVON95 trial compared consolidation treatment with two cycles of bortezomib, lenalidomide, and dexamethasone (VRD) or no consolidation after induction and intensification therapy, followed by continuous lenalidomide maintenance. Primary study end point was progression-free survival (PFS). RESULTS Eight hundred seventy-eight eligible patients were randomly assigned to receive VRD consolidation (451 patients) or no consolidation (427 patients). At a median follow-up of 74.8 months, median PFS with adjustment for pretreatment was prolonged in patients randomly assigned to VRD consolidation (59.3 v 42.9 months, hazard ratio [HR] = 0.81; 95% CI, 0.68 to 0.96; P = .016). The PFS benefit was observed across most predefined subgroups, including revised International Staging System (ISS) stage, cytogenetics, and prior treatment. Revised ISS3 stage (HR, 2.00; 95% CI, 1.41 to 2.86) and ampl1q (HR, 1.67; 95% CI, 1.37 to 2.04) were significant adverse prognostic factors. The median duration of maintenance was 33 months (interquartile range 13-86 months). Response complete response (CR) after consolidation versus no consolidation before start of maintenance was 34% versus 18%, respectively (P < .001). Response >= CR on protocol including maintenance was 59% with consolidation and 46% without (P < .001). Minimal residual disease analysis by flow cytometry in a subgroup of 226 patients with CR or stringent complete response or very good partial response before start of maintenance demonstrated a 74% minimal residual disease-negativity rate in VRD-treated patients. Toxicity from VRD was acceptable and manageable. CONCLUSION Consolidation treatment with VRD followed by lenalidomide maintenance improves PFS and depth of response in newly diagnosed patients with multiple myeloma as compared to maintenance alone. (C) 2021 by American Society of Clinical Oncology
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- 2021
4. When and How to Treat Relapsed Multiple Myeloma
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Nathwani, Nitya, Bertamini, Luca, Banerjee, Rahul, Gay, Francesca, Shah, Nina, and Krishnan, Amrita
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- 2021
5. 2021 European Myeloma Network review and consensus statement on smoldering multiple myeloma: how to distinguish (and manage) Dr. Jekyll and Mr. Hyde
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Musto, Pellegrino Engelhardt, Monika Caers, Jo Bolli, Niccolo' Kaiser, Martin van de Donk, Niels Terpos, Evangelos and Broijl, Annemiek de Larrea, Carlos Fernandez Gay, Francesca and Goldschmidt, Hartmut Hajek, Roman Vangsted, Annette Juul and Zamagni, Elena Zweegman, Sonja Cavo, Michele Dimopoulos, Meletios Einsele, Hermann Ludwig, Heinz Barosi, Giovanni and Boccadoro, Mario Mateos, Maria-Victoria Sonneveld, Pieter and San Miguel, Jesus
- Abstract
According to the updated International Myeloma Working Group criteria, smoldering multiple myeloma (SMM) is an asymptomatic plasma cell disorder characterized by an M-component >3 g/dL, bone marrow plasma cell infiltration >10% and
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- 2021
6. Minimal residual disease in Myeloma: Application for clinical care and new drug registration
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Anderson, Kenneth, Auclair, Daniel, Adam, Stacey J., Agarwal, Amit, Anderson, Melissa, Avet-Loiseau, Hervé, Bustoros, Mark, Chapman, Jessica, Connors, Dana E., Dash, Ajeeta B., Di Bacco, Alessandra, Du, Ling, Facon, Thierry, Flores-Montero, Juan, Gay, Francesca, Ghobrial, Irene M., Gormley, Nicole J., Gupta, Ira, Higley, Howard, Hillengass, Jens, Kanapuru, Bindu, Kazandjian, Dickran, Kelloff, Gary J., Kirsch, Ilan R., Kremer, Brandon, Landgren, Ola, Lightbody, Elizabeth, Lomas, Oliver C., Lonial, Sagar, Mateos, Maria Victoria, Montes de Oca, Rocío, Mukundan, Lata, Munshi, Nikhil, O’Donnell, Elizabeth K., Orfao, Alberto, Paiva, Bruno, Patel, Reshma, Pugh, Trevor J., Ramasamy, Karthik, Ray, Jill, Roshal, Mikhail, Ross, J. A., Sigman, Caroline C., Thoren, Katie L., Trudel, Suzanne, Ulaner, Gary, Valente, Nancy, Weiss, Brendan M., Zamagni, Elena, and Kumar, S.
- Abstract
The development of novel agents has transformed the treatment paradigm for multiple myeloma, with minimal residual disease (MRD) negativity now achievable across the entire disease spectrum. Bone marrow–based technologies to assess MRD, including approaches using next-generation flow and next-generation sequencing, have provided real-time clinical tools for the sensitive detection and monitoring of MRD in patients with multiple myeloma. Complementary liquid biopsy–based assays are now quickly progressing with some, such as mass spectrometry methods, being very close to clinical use, while others utilizing nucleic acid–based technologies are still developing and will prove important to further our understanding of the biology of MRD. On the regulatory front, multiple retrospective individual patient and clinical trial level meta-analyses have already shown and will continue to assess the potential of MRD as a surrogate for patient outcome. Given all this progress, it is not surprising that a number of clinicians are now considering using MRD to inform real-world clinical care of patients across the spectrum from smoldering myeloma to relapsed refractory multiple myeloma, with each disease setting presenting key challenges and questions that will need to be addressed through clinical trials. The pace of advances in targeted and immune therapies in multiple myeloma is unprecedented, and novel MRD-driven biomarker strategies are essential to accelerate innovative clinical trials leading to regulatory approval of novel treatments and continued improvement in patient outcomes.
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- 2021
7. COVID-19 vaccination in patients with multiple myeloma: a consensus of the European Myeloma Network
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Ludwig, Heinz, Sonneveld, Pieter, Facon, Thierry, San Miguel, Jesús F., Avet-Loiseau, Hervé, Mohty, Mohty, Mohamad, Mateos, Maria Victoria, Moreau, Philippe, Cavo, Michele, Pawlyn, Charlotte, Zweegman, Sonja, Engelhardt, Monika, Driessen, Christoph, Cook, Gordon, Dimopoulos, Meletios A., Gay, Francesca, Einsele, Hermann, Delforge, Michel, Caers, Jo, Weisel, Katja C., Jackson, Graham, Garderet, Laurent, Donk, Niels W. C. J. van de, Leleu, Xavier, Goldschmidt, Hartmut, Beksac, Meral, Nijhof, Inger, Schreder, Martin, Abildgaard, Niels, Hajek, Roman, Zojer, Niklas, Kastritis, Efstathios, Broijl, Annemiek, Schjesvold, Fredrik, Boccadoro, Mario, Terpos, Evangelos, and Austrian Forum Against Cancer
- 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
8. COVID-19 vaccination in patients with multiple myeloma: a consensus of the European Myeloma Network
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Ludwig, Heinz Sonneveld, Pieter Facon, Thierry San-Miguel, Jesus Avet-Loiseau, Herve Mohty, Mohamad Mateos, Maria-Victoria Moreau, Philippe Cavo, Michele Pawlyn, Charlotte Zweegman, Sonja Engelhardt, Monika Driessen, Christoph Cook, Gordon Dimopoulos, Melitios A. Gay, Francesca Einsele, Hermann Delforge, Michel Caers, Jo and Weisel, Katja Jackson, Graham Garderet, Laurent van de Donk, Niels Leleu, Xavier Goldschmidt, Hartmut Beksac, Meral and Nijhof, Inger Schreder, Martin Abildgaard, Niels Hajek, Roman Zojer, Niklas Kastritis, Efstathios Broijl, Annemiek and Schjesvold, Fredrik Boccadoro, Mario Terpos, Evangelos
- 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 vaccination in patients with multiple myeloma was condensed into this Review.
- Published
- 2021
9. Clinical Features Associated with COVID-19 Outcome in MM: First Results from International Myeloma Society Dataset
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Chari, Ajai, Samur, Mehmet Kemal, Martinez-Lopez, Joaquin, Cook, Gordon, Biran, Noa, Yong, Kwee L., Hungria, Vania Tietsche de Moraes, Engelhardt, Monika, Gay, Francesca, Garcia-Feria, Ana, Oliva, Stefania, Oostvogels, Rimke, Gozzetti, Alessandro, Rosenbaum, Cara A, Kumar, Shaji K, Stadtmauer, Edward, Einsele, Hermann, Beksac, Meral, Weisel, Katja C, Anderson, Kenneth C, Mateos, Maria-Victoria, Moreau, Philippe, San Miguel, Jesús, Munshi, Nikhil C, and Avet-Loiseau, Hervé
- Published
- 2020
10. Upfront autologous hematopoietic stem-cell transplantation improves overall survival in comparison with bortezomib-based intensification therapy in newly diagnosed multiple myeloma: long-term follow-up analysis of the Randomized Phase 3 EMN02/HO95 Study
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Cavo, Michele Gay, Francesca Beksac, Meral Dimopoulos, Meletios A Pantani, Lucia Petrucci, Maria Teresa Dozza, Luca Van der Holt, Bronno Zweegman, Sonja Zamagni, Elena others
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Health Sciences ,Επιστήμες Υγείας - Published
- 2020
11. European myeloma network perspective on CAR T-Cell therapies for multiple myeloma
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Bruno, Benedetto Wasch, Ralph Engelhardt, Monika Gay, Francesca Giaccone, Luisa D'Agostino, Mattia and Rodriguez-Lobato, Luis-Gerardo Danhof, Sophia Gagelmann, Nico and Kroeger, Nicolaus Popat, Rakesh van de Donk, Niels W. C. J. and Terpos, Evangelos Dimopoulos, Meletios A. Sonneveld, Pieter and Einsele, Hermann Boccadoro, Mario
- Subjects
Health Sciences ,Επιστήμες Υγείας - Abstract
Chimeric antigen receptor (CAR) T cells (CAR-T) have dramatically changed the treatment landscape of B-cell malignancies, providing a potential cure for relapsed/refractory patients. Long-term responses in patients with acute lymphoblastic leukemia and non Hodgkin lymphomas have encouraged further development in myeloma. In particular, B-cell maturation antigen (BCMA)-targeted CAR-T have established very promising results in heavily pre-treated patients. Moreover, CAR-T targeting other antigens (i.e., SLAMF7 and CD44v6) are currently under investigation. However, none of these current autologous therapies have been approved, and despite high overall response rates across studies, main issues such as long-term outcome, toxicities, treatment resistance, and management of complications limit as yet their widespread use. Here, we critically review the most important pre-clinical and clinical findings, recent advances in CAR-T against myeloma, as well as discoveries in the biology of a still incurable disease, that, all together, will further improve safety and efficacy in relapsed/refractory patients, urgently in need of novel treatment options.
- Published
- 2020
12. Bortezomib-Based Transplantation and Consolidation Therapy Followed by Lenalidomide Maintenance for Newly Diagnosed Multiple Myeloma
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Cavo, Michele Gay, Francesca Beksac, Meral Pantani, Lucia Petrucci, Maria Teresa Dimopoulos, Meletios A Dozza, Luca van der Holt, Bronno Oliva, Stefania van der Velden, Vincent HJ others
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Health Sciences ,Επιστήμες Υγείας - Published
- 2020
13. Clinical features and survival of multiple myeloma patients harboring t (14; 16) in the era of novel agents
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Mina, Roberto Joseph, Nisha S Gay, Francesca Kastritis, Efstathios Petrucci, Maria Teresa Kaufman, Jonathan L Montefusco, Vittorio Gavriatopoulou, Maria Patriarca, Francesca Omedé, Paola others
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Health Sciences ,Επιστήμες Υγείας - Published
- 2020
14. Management of patients with multiple myeloma in the era of COVID-19 pandemic: a consensus paper from the European Myeloma Network (EMN)
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Terpos, Evangelos Engelhardt, Monika Cook, Gordon Gay, Francesca Mateos, Maria-Victoria Ntanasis-Stathopoulos, Ioannis van de Donk, Niels WCJ Avet-Loiseau, Hervé Hajek, Roman Vangsted, Annette Juul others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2020
15. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial
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Dimopoulos, Meletios A Gay, Francesca Schjesvold, Fredrik Beksac, Meral Hajek, Roman Weisel, Katja Christina Goldschmidt, Hartmut Maisnar, Vladimir Moreau, Philippe Min, Chang Ki others
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Health Sciences ,Επιστήμες Υγείας - Published
- 2019
16. Double-Negative T Cell Levels Correlate with Chronic Graft-versus-Host Disease Severity
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Moreau, Philippe, Rajkumar, S. Vincent, Mateos, Maria-Victoria, Gay, Francesca, Skacel, Tomas, Schjesvold, Fredrik, Chng, Wee Joo, Hajek, Roman, Zweegman, Sonja, Min, Chang-Ki, Dash, Ajeeta B, Pluta, Agnieszka, Iida, Shinsuke, Labotka, Richard, Teng, Zhaoyang, Spencer, Andrew, Kaiser, Martin, Weisel, Katja Christina, Dimopoulos, Meletios, Beksac, Meral, Suryanarayan, Kaveri, Morgan, Gareth, Maisnar, Vladimir, Goldschmidt, Hartmut, CCA - Cancer Treatment and quality of life, CCA - Cancer biology and immunology, and Hematology
- Subjects
Adult ,Male ,T-Lymphocytes ,medicine.medical_treatment ,T cell ,Graft vs Host Disease ,Hematopoietic stem cell transplantation ,Disease ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,Immune system ,immune system diseases ,hemic and lymphatic diseases ,Humans ,Transplantation, Homologous ,Medicine ,B-cell activating factor ,Pathological ,B cell ,Aged ,B-Lymphocytes ,Transplantation ,business.industry ,Hematopoietic Stem Cell Transplantation ,Hematology ,Middle Aged ,Allografts ,medicine.disease ,3. Good health ,Graft-versus-host disease ,medicine.anatomical_structure ,Hematologic Neoplasms ,030220 oncology & carcinogenesis ,Chronic Disease ,Immunology ,Female ,business ,030215 immunology - Abstract
Chronic graft-versus-host disease (cGVHD) is a major complication, affecting 50% to 80% of long-term survivors of allogeneic hematopoietic stem cell transplantation. Current cGVHD therapies are neither specific nor curative, and patients are typically maintained for several months to years under immunosuppressive regimens that are associated with important side effects and increased susceptibility to life-threatening infections. As a result, continued investigation into the pathology of the disease and the search for novel diagnostic and therapeutic strategies to treat cGVHD remains a high priority. We report that the cellular dynamics of various immune cell subsets are related to cGVHD onset and severity in a cohort of allogeneic hematopoietic stem cell transplantation recipients. We document a decrease in the proportion of CD45RO + CD4 −CD8 − (double-negative [DN]) T cells at the onset of cGVHD, a time at which serum levels of B cell activating factor and B cells are increased. We also find that DN T cell levels are correlated with cGVHD severity. Our present findings are in line with the view that activated DN T cells exhibit their immunoregulatory potential by eliminating B cells in vivo. Taken together, these findings suggest that maintaining elevated DN T cell numbers before the onset of cGVHD may prevent pathological B cell responses.
- Published
- 2019
17. Prevention, monitoring and treatment of cardiovascular adverse events in myeloma patients receiving carfilzomib A consensus paper by the European Myeloma Network and the Italian Society of Arterial Hypertension
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Bringhen, Sara Milan, Alberto D’Agostino, Mattia Ferri, Claudio Wäsch, Ralph Gay, Francesca Larocca, Alessandra Offidani, Massimo Zweegman, Sonja Terpos, Evangelos others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2019
18. Enduring efficacy and tolerability of daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma (GEN503): final results of an open-label, phase 1/2 study
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Plesner, Torben, Arkenau, Hendrik-Tobias, Gay, Francesca, Minnema, Monique C., Boccadoro, Mario, Moreau, Philippe, Cavenagh, Jamie, Perrot, Aurore, Laubach, Jacob P., Krejcik, Jakub, Ahmadi, Tahamtan, de Boer, Carla, Chen, Diana, Chiu, Christopher, Schecter, Jordan M., and Richardson, Paul G.
- Subjects
multiple myeloma ,daratumumab ,monoclonal antibody ,plasma cell disorders ,relapsed/refractory multiple myeloma ,Hematology - Published
- 2019
19. Maintenance therapy with the oral proteasome inhibitor (PI) ixazomib significantly prolongs progression-free survival (PFS) following autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM): phase 3 tourmaline-MM3 trial
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Morgan, Gareth Dimopoulos, Meletios Gay, Francesca Schjesvold, Fredrik Beksac, Meral Hajek, Roman Weisel, Katja Christina Goldschmidt, Hartmut Maisnar, Vladimir Moreau, Philippe others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2019
20. European Myeloma Network Guidelines for the Management of Multiple Myeloma-related Complications
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Terpos, Evangelos, Kleber, Martina, Engelhardt, Monika, Zweegman, Sonja, Gay, Francesca, Kastritis, Efstathios, van de Donk, Niels W C J, Bruno, Benedetto, Sezer, Orhan, Broijl, Annemiek, Bringhen, Sara, Beksac, Meral, Larocca, Alessandra, Hajek, Roman, Musto, Pellegrino, Johnsen, Hans Erik, Morabito, Fortunato, Ludwig, Heinz, Cavo, Michele, Einsele, Hermann, Sonneveld, Pieter, Dimopoulos, Meletios A, Palumbo, Antonio, Hematology, CCA - Innovative therapy, European Myeloma Network, Radiology & Nuclear Medicine, Terpos, Evangelo, Kleber, Martina, Engelhardt, Monika, Zweegman, Sonja, Gay, Francesca, Kastritis, Efstathio, van de Donk, Niels W C J, Bruno, Benedetto, Sezer, Orhan, Broijl, Annemiek, Bringhen, Sara, Beksac, Meral, Larocca, Alessandra, Hajek, Roman, Musto, Pellegrino, Johnsen, Hans Erik, Morabito, Fortunato, Ludwig, Heinz, Cavo, Michele, Einsele, Hermann, Sonneveld, Pieter, Dimopoulos, Meletios A, and Palumbo, Antonio
- Subjects
medicine.medical_specialty ,Bone disease ,Anemia ,Infections ,Asymptomatic ,Guideline Article ,SDG 3 - Good Health and Well-being ,Internal medicine ,medicine ,Humans ,Pain Management ,ddc:610 ,Multiple myeloma ,European Myeloma Network, recommendations ,Hematology ,business.industry ,Bortezomib ,Disease Management ,Peripheral Nervous System Diseases ,Venous Thromboembolism ,medicine.disease ,Surgery ,Zoledronic acid ,Kidney Diseases ,medicine.symptom ,Bone Diseases ,business ,Multiple Myeloma ,Hemophilus ,medicine.drug - Abstract
The European Myeloma Network provides recommendations for the management of the most common complications of multiple myeloma. Whole body low-dose computed tomography is more sensitive than conventional radiography in depicting osteolytic disease and thus we recommend it as the novel standard for the detection of lytic lesions in myeloma (grade 1A). Myeloma patients with adequate renal function and bone disease at diagnosis should be treated with zoledronic acid or pamidronate (grade 1A). Symptomatic patients without lytic lesions on conventional radiography can be treated with zoledronic acid (grade 1B), but its advantage is not clear for patients with no bone involvement on computed tomography or magnetic resonance imaging. In asymptomatic myeloma, bisphosphonates are not recommended (grade 1A). Zoledronic acid should be given continuously, but it is not clear if patients who achieve at least a very good partial response benefit from its continuous use (grade 1B). Treatment with erythropoietic-stimulating agents may be initiated in patients with persistent symptomatic anemia (hemoglobin
- Published
- 2015
21. European myeloma network recommendations on diagnosis and management of patients with rare plasma cell dyscrasias
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Gavriatopoulou, Maria Musto, Pellegrino Caers, Jo Merlini, Giampaolo Kastritis, Efstathios van de Donk, Niels Gay, Francesca Hegenbart, Ute Hajek, Roman Zweegman, Sonja others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2018
22. From transplant to novel cellular therapies in multiple myeloma: European Myeloma Network guidelines and future perspectives
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Gay, Francesca Engelhardt, Monika Terpos, Evangelos Wäsch, Ralph Giaccone, Luisa Auner, Holger W Caers, Jo Gramatzki, Martin Van De Donk, Niels Oliva, Stefania others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2018
23. Cardiovascular adverse events in modern myeloma therapy - Incidence and risks. A review from the European Myeloma Network (EMN) and Italian Society of Arterial Hypertension (SIIA)
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Bringhen, Sara Milan, Alberto Ferri, Claudio Waesch, Ralph and Gay, Francesca Larocca, Alessandra Salvini, Marco and Terpos, Evangelos Goldschmidt, Hartmut Cavo, Michele and Petrucci, Maria Teresa Ludwig, Heinz Auner, Holger W. Caers, Jo Gramatzki, Martin Boccadoro, Mario Einsele, Hermann and Sonneveld, Pieter Engelhardt, Monika European Hematology Assoc and European Myeloma Network Italian Soc Arterial Hypertension
- Abstract
Cardiovascular disease in patients with multiple myeloma may derive from factors unrelated to the disease (age, diabetes, dyslipidemia, obesity, prior cardiovascular diseases), related to the disease (cardiac AL-amyloidosis, hyperviscosity, high-output failure, arterio venous shunting, anemia, renal dysfunction) and/or related to antimyeloma treatment (anthracyclines, corticosteroids, alkylating agents, immunomodulatory drugs, proteasome inhibitors). Good knowledge of cardiovascular events, effective dose reductions, prevention and management of early and late cardiovascular side effects of chemotherapeutic agents are essential in current clinical practice. Myeloma experts are obliged to carefully balance the efficacy and toxicity of drugs for each individual patient. This review summarizes current data and novel insights into cardiovascular adverse events of today's anti-myeloma treatment, focusing on carfilzomib, as a starting point for developing consensus recommendations on preventing and managing cardiovascular side effects in patients with multiple myeloma.
- Published
- 2018
24. Patient-centered practice in elderly myeloma patients: an overview and consensus from the European Myeloma Network (EMN)
- Author
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Larocca, Alessandra Dold, Sandra Maria Zweegman, Sonja Terpos, Evangelos Wäsch, Ralph D’Agostino, Mattia Scheubeck, Sophia Goldschmidt, Hartmut Gay, Francesca Cavo, Michele others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2018
25. Prevention and management of adverse events of novel agents in multiple myeloma: a consensus of the European Myeloma Network
- Author
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Ludwig, Heinz Delforge, Michel Facon, Thierry Einsele, Hermann Gay, Francesca Moreau, Philippe Avet-Loiseau, Hervé Boccadoro, Mario Hajek, Roman Mohty, Mohamad others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2018
26. European myeloma network recommendations on tools for the diagnosis and monitoring of multiple myeloma: What to use and when
- Author
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Caers, Jo Garderet, Laurent Kortüm, K Martin O’Dwyer, Michael E van de Donk, Niels WCJ Binder, Mascha Dold, Sandra Maria Gay, Francesca Corre, Jill Beguin, Yves others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Abstract
The diagnosis of multiple myeloma can be challenging, even for experienced physicians, and requires close collaboration between numerous disciplines (orthopedics, radiology, nuclear medicine, radiation therapy, hematology and oncology) before the final diagnosis of myeloma is made. The definition of multiple myeloma is based on the presence of clinical, biochemical, histopathological, and radiological markers of disease. Specific tests are needed both at presentation and during follow-up in order to reach the correct diagnosis and characterize the disease precisely. These tests can also serve prognostic purposes and are useful for follow-up of myeloma patients. Molecular analyses remain pivotal for defining high-risk myeloma and are used in updated patient strat-ifications, while minimal residual disease assessment via flow cytometry, molecular techniques and radiological approaches provides additional prognostic information on patients’ long-term outcome. This pivotal information will guide our future treatment decisions in forthcoming clinical trials. The European Myeloma Network group updated their guidelines on different diagnostic recommendations, which should be of value to enable appropriate use of the recommendations both at diagnosis and during follow-up. © 2018 Ferrata Storti Foundation.
- Published
- 2018
27. Maintenance therapy with the oral proteasome inhibitor (PI) ixazomib significantly prolongs progression-free survival (PFS) following autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM): phase 3 tourmaline-MM3 trial
- Author
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Dimopoulos, Meletios A Gay, Francesca Schjesvold, Fredrik H Beksac, Meral Hajek, Roman Weisel, Katja Goldschmidt, Hartmut Maisnar, Vladimir Moreau, Philippe Min, Chang-Ki others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2018
28. Time to Improve Bortezomib and Lenalidomide Lines of Therapy
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Guidez, Stephanie, Moreau, Philippe, Leleu, Xavier, Caillot, Denis, Pegourie, Brigitte, Banos, Anne, Terpos, Evangelos, Facon, Thierry, Benboubker, Lofti, Macro, Margaret, Hulin, Cyrille, Karlin, Lionel, Royer, Bruno, Stoppa, Anne-Marie, Garderet, Laurent, Zweegman, Sonja, Chretien, Marie Lorraine, Voog, Eric, Abildgaard , Niels, Richez, Valentine, J. Jurczyszyn, Artur, Demarquette, Hélène, Lancesseur, Charles, Joao, Cristina, Ikhlef, Souhila, Le Du, Katell, and Gay, Francesca Marianatal
- Published
- 2017
29. Intensification Therapy with Bortezomib-Melphalan-Prednisone Versus Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma: An Intergroup, Multicenter, Phase III Study of the European Myeloma Network (EMN02/HO95 MM Trial)
- Author
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Cavo, Michele Beksac, Meral Dimopoulos, Meletios A Pantani, Lucia Gay, Francesca Hájek, Roman Testoni, Nicoletta Mellqvist, Ulf-Henrik Patriarca, Francesca Montefusco, Vittorio others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2016
30. Upfront autologous stem cell transplantation (ASCT) versus novel agent-based therapy for multiple myeloma (MM): A randomized phase 3 study of the European Myeloma Network (EMN02/Ho95 MM trial)
- Author
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Cavo, Michele Palumbo, Antonio Zweegman, Sonja Dimopoulos, Meletios A. Hajek, Roman Pantani, Lucia Beksac, Meral and Wester, Ruth Johnsen, Hans E. Mellqvist, Ulf -Henrik and Petrucci, Maria Teresa Driessen, Christoph Di Raimondo, Francesco Troia, Rossella Pezzi, Annalisa Van der Holt, Bronno Wu, Ka Lung Ludwig, Heinz Gay, Francesca and Sonneveld, Pieter
- Published
- 2016
31. Continuous therapy versus fixed duration of therapy in patients with newly diagnosed multiple myeloma
- Author
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Palumbo, Antonio Gay, Francesca Maria Cavallo, Federica Di Raimondo, Francesco Larocca, Alessandra Hardan, Izhar Nagler, Arnon Petrucci, Maria T Hajek, Roman Pezzatti, Sara others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2015
32. Autologous Transplantation Versus Cyclophosphamide-Lenalidomide-Prednisone Followed By Lenalidomide-Prednisone Versus Lenalidomide Maintenance in Multiple Myeloma: Long-Term Results of a Phase Ill Trial
- Author
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Gay, Francesca, Magarotto, Valeria, Petrucci, Maria Teresa, Di Raimondo, Francesco, Pour, Ludek, Caravita, Tommaso, Scudla, Vlastimil, Cafro, Anna Maria, Liberati, Anna Marina, Spada, Stefano, Vladimir, Maisnar, Pescosta, Norbert, Ria, Roberto, Offidani, Massimo, Bringhen, Sara, Bernardini, Annalisa, Patriarca, Francesca, Corradini, Paolo, Foa, Roberto, Cascavilla, Nicola, Catalano, Lucio, Spencer, Andrew, Roman Hajek, Boccadoro, Mario, and Palumbo, Antonio
- Published
- 2015
33. European Myeloma Network guidelines for the management of multiple myeloma-related complications
- Author
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Terpos, Evangelos Kleber, Martina Engelhardt, Monika Zweegman, Sonja Gay, Francesca Kastritis, Efstathios van de Donk, Niels WCJ Bruno, Benedetto Sezer, Orhan Broijl, Annemiek others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2015
34. Gammopatie monoclonali
- Author
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Boccadoro, Mario, Gay, Francesca Maria, Larocca, Alessandra, Magarotto, Valeria, and Palumbo, Antonio
- Published
- 2015
35. European Myeloma Network recommendations on the evaluation and treatment of newly diagnosed patients with multiple myeloma
- Author
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Monika, Engelhardt, Evangelos, Terpos, Martina, Kleber, Gay, Francesca Maria, Ralph, Wäsch, Gareth, Morgan, Michele, Cavo, Niels van de Donk, Andreas, Beilhack, Bruno, Benedetto, Hans Erik Johnsen, Roman, Hajek, Christoph, Driessen, Heinz, Ludwig, Meral, Beksac, Boccadoro, Mario, Christian, Straka, Sara, Brighen, Martin, Gramatzki, Larocca, Alessandra, Henk, Lokhorst, Magarotto, Valeria, Fortunato, Morabito, Meletios, A Dimopoulos, Hermann, Einsele, Pieter, Sonneveld, Palumbo, Antonio, European Myeloma Network, Plastic and Reconstructive Surgery and Hand Surgery, and Hematology
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,Bortezomib ,medicine.medical_treatment ,Hematopoietic Stem Cell Transplantation ,Hematology ,Hematopoietic stem cell transplantation ,medicine.disease ,Surgery ,Thalidomide ,Transplantation ,Guideline Article ,Autologous stem-cell transplantation ,Clinical Trials, Phase III as Topic ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,business ,Autografts ,Multiple Myeloma ,Dexamethasone ,Multiple myeloma ,medicine.drug ,Lenalidomide - Abstract
Multiple myeloma management has undergone profound changes in the past thanks to advances in our understanding of the disease biology and improvements in treatment and supportive care approaches. This article presents recommendations of the European Myeloma Network for newly diagnosed patients based on the GRADE system for level of evidence. All patients with symptomatic disease should undergo risk stratification to classify patients for International Staging System stage (level of evidence: 1A) and for cytogenetically defined high- versus standard-risk groups (2B). Novel-agent-based induction and up-front autologous stem cell transplantation in medically fit patients remains the standard of care (1A). Induction therapy should include a triple combination of bortezomib, with either adriamycin or thalidomide and dexamethasone (1A), or with cyclophosphamide and dexamethasone (2B). Currently, allogeneic stem cell transplantation may be considered for young patients with high-risk disease and preferably in the context of a clinical trial (2B). Thalidomide (1B) or lenalidomide (1A) maintenance increases progression-free survival and possibly overall survival (2B). Bortezomib-based regimens are a valuable consolidation option, especially for patients who failed excellent response after autologous stem cell transplantation (2A). Bortezomib-melphalan-prednisone or melphalan-prednisone-thalidomide are the standards of care for transplant-ineligible patients (1A). Melphalan-prednisone-lenalidomide with lenalidomide maintenance increases progression-free survival, but overall survival data are needed. New data from the phase III study (MM-020/IFM 07-01) of lenalidomide-low-dose dexamethasone reached its primary end point of a statistically significant improvement in progression-free survival as compared to melphalan-prednisone-thalidomide and provides further evidence for the efficacy of lenalidomide-low-dose dexamethasone in transplant-ineligible patients (2B).
- Published
- 2014
36. Trichoderma species fungemia after high-dose chemotherapy and autologous stem cell transplantation: a case report
- Author
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Festuccia, MORENO BENEDETTO, Giaccone, Luisa, Gay, Francesca Maria, Brunello, Lucia, Maffini, Enrico, Ferrando, F, Talamo, E, Boccadoro, Mario, Serra, R, Barbui, A, and Bruno, Benedetto
- Published
- 2014
37. Chromosome 1 abnormalities in newly diagnosed elderly multiple myeloma patients treated with novel therapies
- Author
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Caltagirone, S, Ruggeri, M, Aschero, S, Gilestro, M, Oddolo, D, Gay, Francesca Maria, Bringhen, S, Musolino, C, Baldini, L, Musto, P, Petrucci, Mt, Gaidano, G, Passera, R, Bruno, Benedetto, Palumbo, Antonio, Boccadoro, Mario, and Omede', P.
- Published
- 2014
38. High XBP1 expression is a marker of better outcome in multiple myeloma patients treated with bortezomib
- Author
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Gambella, Manuela, Rocci, Alberto, Passera, Roberto, Gay, Francesca, Omedè, Paola, Crippa, Claudia, Corradini, Paolo, Romano, Alessandra, Rossi, Davide, Ladetto, Marco, Boccadoro, Mario, and Palumbo, Antonio
- Subjects
Male ,X-Box Binding Protein 1 ,XBP1 ,Myeloma protein ,Antineoplastic Agents ,Regulatory Factor X Transcription Factors ,Biology ,Disease-Free Survival ,BLIMP1 ,Bortezomib ,IRF4 ,medicine ,Biomarkers, Tumor ,Humans ,Letters to the Editor ,Transcription factor ,Multiple myeloma ,Aged ,Neoplastic ,Tumor ,Hematology ,medicine.disease ,Molecular biology ,Boronic Acids ,Neoplasm Proteins ,DNA-Binding Proteins ,Gene Expression Regulation, Neoplastic ,Survival Rate ,medicine.anatomical_structure ,Gene Expression Regulation ,multiple myeloma biomarker ,Pyrazines ,Monoclonal ,Cancer research ,Female ,Bone marrow ,Multiple Myeloma ,Biomarkers ,medicine.drug ,Transcription Factors - Abstract
Multiple myeloma (MM) is a hematologic tumor characterized by accumulation of monoclonal plasma cells (PCs) in the bone marrow (BM) producing antigen-specific immunoglobulins. The transcription factor X box binding protein 1 (XBP1), the interferon regulatory factor 4 (IRF4) and the transcriptional
- Published
- 2014
39. European Myeloma Network recommendations on the evaluation and treatment of newly diagnosed patients with multiple myeloma
- Author
-
Engelhardt, Monika Terpos, Evangelos Kleber, Martina Gay, Francesca Wäsch, Ralph Morgan, Gareth Cavo, Michele van de Donk, Niels Beilhack, Andreas Bruno, Benedetto others
- Subjects
Health Sciences ,Επιστήμες Υγείας - Abstract
Multiple myeloma management has undergone profound changes in the past thanks to advances in our understanding of the disease biology and improvements in treatment and supportive care approaches. This article presents recommendations of the European Myeloma Network for newly diagnosed patients based on the GRADE system for level of evidence. All patients with symptomatic disease should undergo risk stratification to classify patients for International Staging System stage (level of evidence: 1A) and for cytogenetically defined high-versus standard-risk groups (2B). Novel-agent-based induction and up-front autologous stem cell transplantation in medically fit patients remains the standard of care (1A). Induction therapy should include a triple combination of bortezomib, with either adriamycin or thalidomide and dexamethasone (1A), or with cyclophosphamide and dexamethasone (2B). Currently, allogeneic stem cell transplantation may be considered for young patients with high-risk disease and preferably in the context of a clinical trial (2B). Thalidomide (1B) or lenalidomide (1A) maintenance increases progression-free survival and possibly overall survival (2B). Bortezomib-based regimens are a valuable consolidation option, especially for patients who failed excellent response after autologous stem cell transplantation (2A). Bortezomib-melphalan-prednisone or melphalan-prednisone-thalidomide are the standards of care for transplant-ineligible patients (1A). Melphalan-prednisone-lenalidomide with lenalidomide maintenance increases progression-free survival, but overall survival data are needed. New data from the phase III study (MM-020/IFM 07-01) of lenalidomide-low-dose dexamethasone reached its primary end point of a statistically significant improvement in progression-free survival as compared to melphalan-prednisone-thalidomide and provides further evidence for the efficacy of lenalidomide-low-dose dexamethasone in transplant-ineligible patients (2B).
- Published
- 2014
40. Multiple myeloma: management of adverse events
- Author
-
Gay, Francesca Maria and Palumbo, Antonio
- Subjects
Melphalan ,Oncology ,Cancer Research ,medicine.medical_specialty ,Gastrointestinal Diseases ,Antineoplastic Agents ,Infections ,Prednisone ,Internal medicine ,Hematologic Agents ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Blood Transfusion ,Intensive care medicine ,Adverse effect ,Dexamethasone ,Multiple myeloma ,Lenalidomide ,Aged ,Aged, 80 and over ,Venous Thrombosis ,Dose-Response Relationship, Drug ,Bortezomib ,business.industry ,Hematopoietic Stem Cell Transplantation ,Hematology ,General Medicine ,medicine.disease ,Combined Modality Therapy ,Hematologic Diseases ,Thalidomide ,Kidney Diseases ,Drug Eruptions ,Nervous System Diseases ,business ,Multiple Myeloma ,medicine.drug - Abstract
The combination of conventional chemotherapy or dexamethasone with new drugs, such as immunomodulatory agents and proteasome inhibitors, has substantially changed the treatment paradigm of myeloma patients. New drugs have been incorporated in pre-transplant induction regimens and post-transplant consolidation and maintenance strategies for young patients; in elderly patients, standard melphalan and prednisone (MP) plus thalidomide or plus bortezomib are now considered standards of care, and ongoing trials are assessing if lenalidomide plus standard MP or plus low-dose dexamethasone may be other options. The efficacy of these drugs needs to be balanced against their toxicity. Different drugs have a different toxicity profile. The choice for the best treatment strategy for every single patient should be based on results of scientific randomized studies but tailored to account for patient’s biological age, comorbidities, and the expected toxicity profile of different regimens. Prompt dose reduction and accurate management of treatment-related toxicity can greatly reduce early discontinuation rate and significantly improve treatment efficacy. This chapter will focus on frequency and management of main adverse events in newly diagnosed and relapsed myeloma patients and will provide guidelines for dose reductions and supportive therapy.
- Published
- 2009
41. INTERMEDIATE-DOSE MELPHALAN (100MG/M2), THALIDOMIDE, DEXAMETHASONE AND STEM CELL SUPPORT IN PATIENTS WITH REFRACTORY OR RELAPSED MYELOMA
- Author
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Musto, P., Avonto, I., Scalzulli, P. R., Bruno, Benedetto, Falcone, A., Ambrosini, M. T., Bringhen, S., Gay, Francesca Maria, Rus, C., Cavallo, Federica, Falco, P., Massaia, Massimo, Boccadoro, Mario, and Palumbo, Antonio
- Published
- 2006
42. Impact of Treatment Intensification According to Patient Prognosis: A Pooled Analysis of 3 Randomized Phase III Trials
- Author
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Gay, Francesca, D Agostino, Mattia, Roman Hajek, Bringhen, Sara, Conticello, Concetta, Gaidano, Gianluca, Montefusco, Vittorio, Pezzatti, Sara, Salvini, Marco, Caravita, Tommaso, Cafro, Anna Maria, Cavo, Michele, Ruggeri, Marina, Morabito, Fortunato, Mina, Roberto, Baldini, Luca, Benevolo, Giulia, Guglielmelli, Tommasina, Bernardini, Annalisa, Foa, Roberto, Patriarca, Francesca, Offidani, Massimo, Ria, Roberto, Ben Yehuda, Dina, Petrucci, Maria Teresa, Spencer, Andrew, Palumbo, Antonio, and Boccadoro, Mario
- Subjects
Immunology ,Cell Biology ,Hematology ,Biochemistry - Abstract
Introduction: Risk-adapted therapy in curable hematologic malignancies is commonly applied: low-risk patients (pts) may be cured with less intensive treatment, avoiding excessive toxicity, whereas high-riskpts require more intensive and toxic regimens. In multiple myeloma (MM), this model may not apply, since the disease is incurable. In recent years, there has been a marked improvement in patient outcome, due to the introduction of novel agents and optimized treatment strategies, including the use of transplant and maintenance. A better evaluation ofpts prognosis based on the new revised international staging system (R-ISS) has been also introduced in clinical practice. The objective of this analysis was to evaluate the impact of treatment intensification (specifically autologous stem cell transplantation [ASCT] and maintenance) inpts with different prognostic features. Methods: Data from 3 phase III randomized trials in newly diagnosed MMpts (RV-MM-209; EMN441; GIMEMA-MM0305) were pooled together and analyzed. Baseline patient risk assessment was estimated using R-ISS. We evaluated: 1) the impact of treatment intensification with high-dose therapy followed by ASCTvs no-ASCT inpts with R-ISS Stage Ivs Stage II/III; 2) the impact of treatment intensification with maintenancevs no maintenance inpts with R-ISS Stage Ivs Stage II/III. RV-MM-209 and EMN441 studies randomizedpts to ASCTvs no-ASCT; allpts in the GIMEMA-MM0305 trial did not receive ASCT and were excluded from the first comparison; RV-MM-209 and GIMEMA-MM0305 studies randomizedpts to maintenance or no maintenance after induction/consolidation; allpts in the EMN441 trial received maintenance and were excluded from the second comparison. We evaluated progression free survival-1 (PFS1), PFS2 and overall survival (OS). Cox proportional hazards models were used to estimate hazard ratios (HRs). To account for potential confounders, the comparisons between ASCTvs no-ASCT and maintenancevs no maintenance were adjusted for the trial effect and the main prognostic features. Results: Overall, 1302 pts were enrolled in the 3 trials. Median follow-up was 4 years.Comparison ASCTvs no-ASCT: 791pts were enrolled in the 2 trials, 529 were eligible for the ASCTvs no ASCT comparison. R-ISS Stage data were available for 419 pts. There was an overall advantage for ASCTvs no-ASCT in PFS1 (0.53; p Conclusions: Both ASCT and maintenance improved PFS1, PFS2 and OS in MM pts. The highest survival was reported in patients with R-ISS Stage I receiving ASCT and/or maintenance. Low-riskpts (R-ISS Stage I) not undergoing intensification with ASCT or maintenance lose their prognostic advantage over high-risk patients receiving the same intensification. Figure 1. Figure 1. Disclosures Gay: Janssen-Cilag: Other: Advisory Board; Celgene: Honoraria; Amgen: Honoraria; BMS: Honoraria; Takeda: Honoraria, Other: Advisory Board; Mundipharma: Other: Advisory Board. Hajek:Novartis: Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Onyx: Consultancy; BMS: Honoraria; Amgen: Consultancy, Honoraria, Research Funding. Bringhen:Mundipharma: Other: Advisory Board; Karyopharm: Other: Advisory Board; BMS: Honoraria; Janssen-Cilag: Honoraria; Amgen: Other: Advisory Board; Celgene: Honoraria. Gaidano:Gilead: Consultancy, Honoraria, Speakers Bureau; Morphosys: Consultancy, Honoraria; Roche: Consultancy, Honoraria, Speakers Bureau; Karyopharm: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau. Caravita:Janssen-Cilag: Honoraria. Cavo:Millennium: Consultancy, Honoraria; Janssen-Cilag: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Amgen: Consultancy, Honoraria. Foà:Pfizer: Speakers Bureau; Ariad: Speakers Bureau; BMS: Consultancy; Celgene: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Gilead: Consultancy, Speakers Bureau; Janssen-Cilag: Consultancy, Speakers Bureau; Genetech: Consultancy; Roche: Consultancy, Speakers Bureau. Patriarca:Bristol-Myers Squibb: Other: Advisory board; Mundipharma: Other: Advisory board; Janssen-Cilag: Other: Advisory board; MSD: Consultancy; Celgene: Consultancy. Ria:Italfarmaco: Consultancy, Speakers Bureau; Janssen-Cilag: Other: Advisory Board, Speakers Bureau; CSL Behring: Consultancy, Research Funding, Speakers Bureau; Binding Site: Speakers Bureau; BMS: Speakers Bureau; BMS: Speakers Bureau. Palumbo:Janssen Cilag: Honoraria; Takeda: Employment, Honoraria. Boccadoro:Novartis: Honoraria, Research Funding; Mundipharma: Research Funding; SANOFI: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Abbivie: Honoraria; Amgen: Honoraria, Research Funding; CELGENE: Honoraria, Research Funding; BMS: Honoraria, Research Funding.
43. Outcome of paraosseous extra-medullary disease in newly diagnosed multiple myeloma patients treated with new drugs
- Author
-
Vittorio Montefusco, Francesca Gay, Stefano Spada, Lorenzo De Paoli, Francesco Di Raimondo, Rossella Ribolla, Caterina Musolino, Francesca Patriarca, Pellegrino Musto, Piero Galieni, Stelvio Ballanti, Chiara Nozzoli, Nicola Cascavilla, Dina Ben-Yehuda, Arnon Nagler, Roman Hajek, Massimo Offidani, Anna Marina Liberati, Pieter Sonneveld, Michele Cavo, Paolo Corradini, Mario Boccadoro, Montefusco, Vittorio, Gay, Francesca, Spada, Stefano, De Paoli, Lorenzo, Di Raimondo, Francesco, Ribolla, Rossella, Musolino, Caterina, Patriarca, Francesca, Musto, Pellegrino, Galieni, Piero, Ballanti, Stelvio, Nozzoli, Chiara, Cascavilla, Nicola, Ben-Yehuda, Dina, Nagler, Arnon, Hajek, Roman, Offidani, Massimo, Liberati, Anna Marina, Sonneveld, Pieter, Cavo, Michele, Corradini, Paolo, Boccadoro, Mario, and Hematology
- Subjects
medicine.medical_specialty ,Medullary cavity ,Disease ,Single Center ,Gastroenterology ,Article ,Plasma Cell Disorders ,multiple myeloma, Extramedullary disease, new drugs ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Progression-free survival ,Lenalidomide ,Multiple myeloma ,Proportional Hazards Models ,Proportional hazards model ,business.industry ,Hazard ratio ,Hematology ,medicine.disease ,Progression-Free Survival ,Pharmaceutical Preparations ,business ,Multiple Myeloma ,030215 immunology ,medicine.drug - Abstract
Extramedullary disease is relatively frequent in multiple myeloma, but our knowledge on the subject is limited and mainly relies on small case series or single center experiences. Little is known regarding the role of new drugs in this setting. We performed a meta-analysis of eight trials focused on the description of extramedullary disease characteristics, clinical outcome, and response to new drugs. A total of 2,332 newly diagnosed myeloma patients have been included; 267 (11.4%) had extramedullary disease, defined as paraosseous in 243 (10.4%), extramedullary plasmocytoma in 12 (0.5%), and not classified in 12 (0.5%) patients. Median progression-free survival was 25.3 months and 25.2 in extramedullary disease and non-extramedullary disease patients, respectively. In multivariate analysis the presence of extramedullary disease did not impact on progression-free survival (hazard ratio 1.15, P=0.06), while other known prognostic factors retained their significance. Patients treated with immunomodulatory drugs, mainly lenalidomide, or proteasome inhibitors had similar progression-free survival and progression-free survival-2 regardless of extramedullary disease presence. Median overall survival was 63.5 months and 79.9 months (P=0.01) in extramedullary and non-extramedullary disease patients, respectively, and in multivariate analysis the presence of extramedullary disease was associated with a reduced overall survival (hazard ratio 1.41, P
- Published
- 2020
44. Cardiovascular adverse events in modern myeloma therapy – Incidence and risks. A review from the European Myeloma Network (EMN) and Italian Society of Arterial Hypertension (SIIA)
- Author
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Sara Bringhen, Alberto Milan, Claudio Ferri, Ralph Wäsch, Francesca Gay, Alessandra Larocca, Marco Salvini, Evangelos Terpos, Hartmut Goldschmidt, Michele Cavo, Maria Teresa Petrucci, Heinz Ludwig, Holger W. Auner, Jo Caers, Martin Gramatzki, Mario Boccadoro, Hermann Einsele, Pieter Sonneveld, Monika Engelhardt, Bringhen, Sara, Milan, Alberto, Ferri, Claudio, Wäsch, Ralph, Gay, Francesca, Larocca, Alessandra, Salvini, Marco, Terpos, Evangelo, Goldschmidt, Hartmut, Cavo, Michele, Petrucci, Maria Teresa, Ludwig, Heinz, Auner, Holger W, Caers, Jo, Gramatzki, Martin, Boccadoro, Mario, Einsele, Hermann, Sonneveld, Pieter, and Engelhardt, Monika
- Subjects
DIAGNOSED MULTIPLE-MYELOMA ,Review Article ,Disease ,chemistry.chemical_compound ,0302 clinical medicine ,CYCLOPHOSPHAMIDE ,Antineoplastic Combined Chemotherapy Protocols ,Public Health Surveillance ,Molecular Targeted Therapy ,PROTEASOME INHIBITORS ,1102 Cardiorespiratory Medicine and Haematology ,Multiple myeloma ,LENALIDOMIDE ,carfilzomib ,Hematology ,cardiovascular ,Incidence ,OPEN-LABEL ,Europe ,Italy ,Cardiovascular Diseases ,European Hematology Association, the European Myeloma Network and the Italian Society of Arterial Hypertension ,030220 oncology & carcinogenesis ,CARDIAC-FAILURE ,Multiple Myeloma ,Life Sciences & Biomedicine ,Risk ,medicine.medical_specialty ,LOW-DOSE DEXAMETHASONE ,Immunology ,03 medical and health sciences ,Internal medicine ,Diabetes mellitus ,medicine ,Humans ,THALIDOMIDE ,Intensive care medicine ,Adverse effect ,multiple myeloma, Cardiovascular disease ,Cardiotoxicity ,Science & Technology ,business.industry ,medicine.disease ,Carfilzomib ,chemistry ,PHASE-3 ENDEAVOR ,business ,Dyslipidemia ,030215 immunology - Abstract
Cardiovascular disease in patients with multiple myeloma may derive from factors unrelated to the disease (age, diabetes, dyslipidemia, obesity, prior cardiovascular diseases), related to the disease (cardiac AL-amyloidosis, hyperviscosity, high-output failure, arteriovenous shunting, anemia, renal dysfunction) and/or related to anti-myeloma treatment (anthracyclines, corticosteroids, alkylating agents, immunomodulatory drugs, proteasome inhibitors). Good knowledge of cardiovascular events, effective dose reductions, prevention and management of early and late cardiovascular side effects of chemotherapeutic agents are essential in current clinical practice. Myeloma experts are obliged to carefully balance the efficacy and toxicity of drugs for each individual patient. This review summarizes current data and novel insights into cardiovascular adverse events of today's anti-myeloma treatment, focusing on carfilzomib, as a starting point for developing consensus recommendations on preventing and managing cardiovascular side effects in patients with multiple myeloma.
- Published
- 2018
45. Interpretation criteria for FDG PET/CT in multiple myeloma (IMPeTUs): final results. IMPeTUs (Italian myeloma criteria for PET USe)
- Author
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Cristina Nanni, Annibale Versari, Stephane Chauvie, Elisa Bertone, Andrea Bianchi, Marco Rensi, Marilena Bellò, Andrea Gallamini, Francesca Patriarca, Francesca Gay, Barbara Gamberi, Pietro Ghedini, Michele Cavo, Stefano Fanti, Elena Zamagni, Nanni, Cristina, Versari, Annibale, Chauvie, Stephane, Bertone, Elisa, Bianchi, Andrea, Rensi, Marco, Bellò, Marilena, Gallamini, Andrea, Patriarca, Francesca, Gay, Francesca, Gamberi, Barbara, Ghedini, Pietro, Cavo, Michele, Fanti, Stefano, and Zamagni, Elena
- Subjects
Adult ,Male ,Concordance ,FDG PET/CT ,IMPeTUs ,Interpretation criteria ,Multiple myeloma ,Standardization ,Aged ,Female ,Fluorodeoxyglucose F18 ,Humans ,Italy ,Middle Aged ,Multiple Myeloma ,Positron-Emission Tomography ,Prospective Studies ,Radiopharmaceuticals ,Reproducibility of Results ,Tomography, X-Ray Computed ,Positron Emission Tomography Computed Tomography ,IMPeTU ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Nuclear Medicine and Imaging ,Multicenter trial ,medicine ,Radiology, Nuclear Medicine and imaging ,Stage (cooking) ,Prospective cohort study ,Tomography ,Fluorodeoxyglucose ,medicine.diagnostic_test ,business.industry ,Radiology, Nuclear Medicine and Imaging ,General Medicine ,medicine.disease ,X-Ray Computed ,Positron emission tomography ,030220 oncology & carcinogenesis ,Radiology ,business ,Nuclear medicine ,Emission computed tomography ,medicine.drug - Abstract
FDG PET/CT (18F-fluoro-deoxy-glucose positron emission tomography/computed tomography) is a useful tool to image multiple myeloma (MM). However, simple and reproducible reporting criteria are still lacking and there is the need for harmonization. Recently, a group of Italian nuclear medicine experts defined new visual descriptive criteria (Italian Myeloma criteria for Pet Use: IMPeTUs) to standardize FDG PET/CT evaluation in MM patients. The aim of this study was to assess IMPeTUs reproducibility on a large prospective cohort of MM patients. MATERIALS AND METHODS: Patients affected by symptomatic MM who had performed an FDG PET/CT at baseline (PET0), after induction (PET-AI), and the end of treatment (PET-EoT) were prospectively enrolled in a multicenter trial (EMN02)(NCT01910987; MMY3033). After anonymization, PET images were uploaded in the web platform WIDEN® and hence distributed to five expert nuclear medicine reviewers for a blinded independent central review according to the IMPeTUs criteria. Consensus among reviewers was measured by the percentage of agreement and the Krippendorff's alpha. Furthermore, on a patient-based analysis, the concordance among all the reviewers in terms of positivity or negativity of the FDG PET/CT scan was tested for different thresholds of positivity (Deauville score (DS 2, 3, 4, 5) for the main parameters (bone marrow, focal score, extra-medullary disease). RESULTS: Eighty-six patients (211 FDG PET/CT scans) were included in this analysis. Median patient age was 58 years (range, 35-66 years), 45% were male, 15% of them were in stage ISS (International Staging System) III, and 42% had high-risk cytogenetics. The percentage agreement was superior to 75% for all the time points, reaching 100% of agreement in assessing the presence skull lesions after therapy. Comparable results were obtained when the agreement analysis was performed using the Krippendorff's alpha coefficient, either in every single time point of scanning (PET0, PET-AI or PET-EoT) or overall for all the scans together. DS proved highly reproducible with the highest reproducibility for score 4. CONCLUSIONS: IMPeTUs criteria proved highly reproducible and could therefore be considered as a base for harmonizing PET interpretation in multiple myeloma. A prospective clinical validation of IMPeTUs criteria is underway.
- Published
- 2017
46. European Myeloma Network recommendations on tools for the diagnosis and monitoring of multiple myeloma: what to use and when
- Author
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Jo Caers, Laurent Garderet, K. Martin Kortüm, Michael E. O’Dwyer, Niels W.C.J. van de Donk, Mascha Binder, Sandra Maria Dold, Francesca Gay, Jill Corre, Yves Beguin, Heinz Ludwig, Alessandra Larocca, Christoph Driessen, Meletios A. Dimopoulos, Mario Boccadoro, Martin Gramatzki, Sonja Zweegman, Hermann Einsele, Michele Cavo, Hartmut Goldschmidt, Pieter Sonneveld, Michel Delforge, Holger W. Auner, Evangelos Terpos, Monika Engelhardt, Caers, Jo, Garderet, Laurent, Kortüm, K Martin, O'Dwyer, Michael E, van de Donk, Niels W C J, Binder, Mascha, Dold, Sandra Maria, Gay, Francesca, Corre, Jill, Beguin, Yve, Ludwig, Heinz, Larocca, Alessandra, Driessen, Christoph, Dimopoulos, Meletios A, Boccadoro, Mario, Gramatzki, Martin, Zweegman, Sonja, Einsele, Hermann, Cavo, Michele, Goldschmidt, Hartmut, Sonneveld, Pieter, Delforge, Michel, Auner, Holger W, Terpos, Evangelo, Engelhardt, Monika, CCA - Cancer Treatment and quality of life, and Hematology
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Monitoring ,medicine.medical_treatment ,FREE LIGHT-CHAIN ,Immunology ,MEDLINE ,MINIMAL RESIDUAL DISEASE ,CIRCULATING PLASMA-CELLS ,Disease ,1102 Cardiovascular Medicine And Haematology ,INTERNATIONAL STAGING SYSTEM ,Guideline Article ,Cytogenetics ,03 medical and health sciences ,0302 clinical medicine ,POSITRON-EMISSION-TOMOGRAPHY ,Internal medicine ,Diagnosis ,PROGNOSTIC-SIGNIFICANCE ,medicine ,Intensive care medicine ,Multiple myeloma ,GENE-EXPRESSION ,Minimal Residual Disease ,Hematology ,Science & Technology ,INTERGROUPE FRANCOPHONE ,business.industry ,medicine.disease ,Minimal residual disease ,3. Good health ,Clinical trial ,Radiation therapy ,multiple myeloma ,HIGH-RISK ,030104 developmental biology ,030220 oncology & carcinogenesis ,Radiological weapon ,Practice Guidelines as Topic ,DELETION 17P ,business ,Life Sciences & Biomedicine ,Multiple Myeloma - Abstract
The diagnosis of multiple myeloma can be challenging, even for experienced physicians, and requires close collaboration between numerous disciplines (orthopedics, radiology, nuclear medicine, radiation therapy, hematology and oncology) before the final diagnosis of myeloma is made. The definition of multiple myeloma is based on the presence of clinical, biochemical, histopathological, and radiological markers of disease. Specific tests are needed both at presentation and during follow-up in order to reach the correct diagnosis and characterize the disease precisely. These tests can also serve prognostic purposes and are useful for follow-up of myeloma patients. Molecular analyses remain pivotal for defining high-risk myeloma and are used in updated patient stratifications, while minimal residual disease assessment via flow cytometry, molecular techniques and radiological approaches provides additional prognostic information on patients' long-term outcome. This pivotal information will guide our future treatment decisions in forthcoming clinical trials. The European Myeloma Network group updated their guidelines on different diagnostic recommendations, which should be of value to enable appropriate use of the recommendations both at diagnosis and during follow-up. ispartof: HAEMATOLOGICA vol:103 issue:11 pages:1772-1784 ispartof: location:Italy status: published
- Published
- 2018
47. Patient-centered practice in elderly myeloma patients: an overview and consensus from the European Myeloma Network (EMN)
- Author
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Alessandra Larocca, Sandra Maria Dold, Sonja Zweegman, Evangelos Terpos, Ralph Wäsch, Mattia D’Agostino, Sophia Scheubeck, Hartmut Goldschmidt, Francesca Gay, Michele Cavo, Heinz Ludwig, Christian Straka, Sara Bringhen, Holger W. Auner, Jo Caers, Martin Gramatzki, Massimo Offidani, Meletios A. Dimopoulos, Hermann Einsele, Mario Boccadoro, Pieter Sonneveld, Monika Engelhardt, Hematology, Larocca, Alessandra, Dold, Sandra Maria, Zweegman, Sonja, Terpos, Evangelo, Wäsch, Ralph, D'Agostino, Mattia, Scheubeck, Sophia, Goldschmidt, Hartmut, Gay, Francesca, Cavo, Michele, Ludwig, Heinz, Straka, Christian, Bringhen, Sara, Auner, Holger W, Caers, Jo, Gramatzki, Martin, Offidani, Massimo, Dimopoulos, Meletios A, Einsele, Hermann, Boccadoro, Mario, Sonneveld, Pieter, and Engelhardt, Monika
- Subjects
Cancer Research ,DIAGNOSED MULTIPLE-MYELOMA ,Salvage therapy ,Disease ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Patient-Centered Care ,Medicine ,DARATUMUMAB MONOTHERAPY ,Multiple myeloma ,education.field_of_study ,COMPREHENSIVE GERIATRIC ASSESSMENT ,Hematology ,OPEN-LABEL ,humanities ,Europe ,Oncology ,030220 oncology & carcinogenesis ,COMORBIDITY INDEX ,Practice Guidelines as Topic ,Multiple Myeloma ,Multiple myeloma, Elderly patients ,Life Sciences & Biomedicine ,medicine.medical_specialty ,LOW-DOSE DEXAMETHASONE ,Population ,Immunology ,MEDLINE ,03 medical and health sciences ,Humans ,Intensive care medicine ,education ,Geriatric Assessment ,Aged ,Science & Technology ,business.industry ,WORKING GROUP ,STEM-CELL TRANSPLANTATION ,1103 Clinical Sciences ,medicine.disease ,RANDOMIZED-TRIALS ,Clinical trial ,Life expectancy ,BORTEZOMIB-MELPHALAN-PREDNISONE ,business ,1112 Oncology And Carcinogenesis ,030215 immunology - Abstract
Multiple myeloma is a disease typical of the elderly, and, because of the increase in life expectancy of the general population, its incidence is expected to grow in the future. Elderly patients represent a particular challenge due to their marked hete rogeneity. Many new and highly effective drugs have been introduced in the last few years, and resu lts from clinical trials are promising. Besides the availability of novel agents, a careful evaluation of elderly patients showed to be a key factor for the success of therapy. A geriatric assessment is a valid strategy to better stratify patients. In particular, different scores are available today to appropriately assess elderly patients and define their fitness/frailty status. The choice of treatm ent – transplantation, triplets, doublets, or reduced- dose therapies including novel agents – should depend on the patient’s fitness status (fit, intermediate-fit or frail). Second-generation no vel agents have also been evaluated as salvage therapy in the elderly, and these new agents certai nly represent a further step forward in the treatment armamentarium for elderly patients with multiple myeloma.
- Published
- 2018
48. From transplant to novel cellular therapies in multiple myeloma: EMN guidelines and future perspectives
- Author
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Gay, F, Engelhardt, M, Terpos, E, Wäsch, R, Giaccone, L, Auner, HW, Caers, J, Gramatzki, M, Van de Donk, N, Oliva, S, Zamagni, E, Garderet, L, Straka, C, Hajek, R, Ludwig, H, Einsele, H, Dimopoulos, M, Boccadoro, M, Kröger, N, Cavo, M, Goldschmidt, H, Bruno, B, Sonneveld, P, Gay, Francesca, Engelhardt, Monika, Terpos, Evangelo, Wäsch, Ralph, Giaccone, Luisa, Auner, Holger W, Caers, Jo, Gramatzki, Martin, van de Donk, Niel, Oliva, Stefania, Zamagni, Elena, Garderet, Laurent, Straka, Christian, Hajek, Roman, Ludwig, Heinz, Einsele, Hermann, Dimopoulos, Meletio, Boccadoro, Mario, Kröger, Nicolau, Cavo, Michele, Goldschmidt, Hartmut, Bruno, Benedetto, and Sonneveld, Pieter
- Subjects
allogeneic ,Immunology ,novel agents ,Hematology ,autologous ,Multiple Myeloma ,1102 Cardiovascular Medicine And Haematology ,Stem Cell Transplantation ,autologou - Abstract
Survival of myeloma patients has greatly improved with the use of autologous stem cell transplantation and novel agents, such as proteasome inhibitors, immunomodulatory drugs and monoclonal antibodies. Compared to bortezomib- and lenalidomide-based regimens alone, the addition of high-dose melphalan followed by autologous transplantation significantly improves progression-free survival; although an overall survival benefit was not observed in all trials. Moreover, follow-up of recent trials is still too short to show any difference in survival. In the light of these findings, novel agent-based induction followed by autologous transplantation is considered the standard upfront treatment for eligible patients (level of evidence: 1A). Post-transplant consolidation and maintenance treatment can further improve patient outcome (1A). The availability of several novel agents has led to the development of multiple combination regimens as salvage treatment options. In this context, the role of salvage autologous transplantation and allotransplant have not been extensively evaluated. In case of prolonged remission after upfront autologous transplantation, another autologous transplantation at relapse can be considered (2B). Patients who experience early relapse and/or have high-risk features have a poor prognosis and may be considered as candidates for clinical trials that - in young and fit patients - may also include an allograft in combination with novel agents (2B). Ongoing studies are evaluating the role of novel cellular therapies, such as inclusion of antibody-based triplets and quadruplets and Chimeric Antigen Receptor-T cells: despite preliminary encouraging results, longer follow-up and larger patient numbers are needed before their clinical use can be widely recommended.
- Published
- 2018
49. Prevention and management of adverse events of novel agents in multiple myeloma: a consensus of the European Myeloma Network
- Author
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Heinz Ludwig, Michel Delforge, Thierry Facon, Hermann Einsele, Francesca Gay, Philippe Moreau, Hervé Avet-Loiseau, Mario Boccadoro, Roman Hajek, Mohamad Mohty, Michele Cavo, Meletios A Dimopoulos, Jesús F San-Miguel, Evangelos Terpos, Sonja Zweegman, Laurent Garderet, María-Victoria Mateos, Gordon Cook, Xavier Leleu, Hartmut Goldschmidt, Graham Jackson, Martin Kaiser, Katja Weisel, Niels W. C. J. van de Donk, Anders Waage, Meral Beksac, Ulf H. Mellqvist, Monika Engelhardt, Jo Caers, Christoph Driessen, Joan Bladé, Pieter Sonneveld, Ludwig, Heinz, Delforge, Michel, Facon, Thierry, Einsele, Hermann, Gay, Francesca, Moreau, Philippe, Avet-Loiseau, Hervé, Boccadoro, Mario, Hajek, Roman, Mohty, Mohamad, Cavo, Michele, Dimopoulos, Meletios A, San-Miguel, Jesús F, Terpos, Evangelo, Zweegman, Sonja, Garderet, Laurent, Mateos, María-Victoria, Cook, Gordon, Leleu, Xavier, Goldschmidt, Hartmut, Jackson, Graham, Kaiser, Martin, Weisel, Katja, van de Donk, Niels W C J, Waage, Ander, Beksac, Meral, Mellqvist, Ulf H, Engelhardt, Monika, Caers, Jo, Driessen, Christoph, Bladé, Joan, Sonneveld, Pieter, and Hematology
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Cancer Research ,2ND MALIGNANCIES ,Review Article ,0302 clinical medicine ,Multiple myeloma ,Molecular Targeted Therapy ,Disease management (health) ,Antineoplastic Agents ,Disease Management ,Drug-Related Side Effects and Adverse Reactions ,Humans ,Incidence ,Multiple Myeloma ,Practice Guidelines as Topic ,Risk Assessment ,media_common ,Drugs ,Hematology ,3. Good health ,Drug class ,Oncology ,030220 oncology & carcinogenesis ,Risk assessment ,Life Sciences & Biomedicine ,LENALIDOMIDE TREATMENT ,Drug ,medicine.medical_specialty ,multiple myeloma adverse events novel agents European Myeloma Network ,INELIGIBLE PATIENTS ,Side effect ,media_common.quotation_subject ,MEDLINE ,HERPES-ZOSTER ,Novel substances ,03 medical and health sciences ,SUPPORTIVE CARE ,medicine ,THALIDOMIDE ,Intensive care medicine ,Adverse effect ,VENOUS THROMBOEMBOLISM ,Science & Technology ,business.industry ,STEM-CELL TRANSPLANTATION ,medicine.disease ,CARFILZOMIB ,business ,PERIPHERAL NEUROPATHY ,030215 immunology - Abstract
During the last few years, several new drugs have been introduced for treatment of patients with multiple myeloma, which have significantly improved the treatment outcome. All of these novel substances differ at least in part in their mode of action from similar drugs of the same drug class, or are representatives of new drug classes, and as such present with very specific side effect profiles. In this review, we summarize these adverse events, provide information on their prevention, and give practical guidance for monitoring of patients and for management of adverse events. ispartof: LEUKEMIA vol:32 issue:7 pages:1542-1560 ispartof: location:England status: published
- Published
- 2018
50. Image interpretation criteria for FDG PET/CT in multiple myeloma: a new proposal from an Italian expert panel. IMPeTUs (Italian Myeloma criteria for PET USe)
- Author
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Cristina Nanni, Elena Zamagni, Annibale Versari, Stephane Chauvie, Andrea Bianchi, Marco Rensi, Marilena Bellò, Ilaria Rambaldi, Andrea Gallamini, Francesca Patriarca, Francesca Gay, Barbara Gamberi, Michele Cavo, Stefano Fanti, Nanni, Cristina, Zamagni, Elena, Versari, Annibale, Chauvie, Stephane, Bianchi, Andrea, Rensi, Marco, Bellò, Marilena, Rambaldi, Ilaria, Gallamini, Andrea, Patriarca, Francesca, Gay, Francesca, Gamberi, Barbara, Cavo, Michele, and Fanti, Stefano
- Subjects
Target lesion ,FDG PET/CT ,IMPeTUs ,Interpretation criteria ,Multiple myeloma ,Standardization ,Adult ,Aged ,Fluorodeoxyglucose F18 ,Fractures, Bone ,Humans ,Image Interpretation, Computer-Assisted ,Image Processing, Computer-Assisted ,Italy ,Middle Aged ,Multimodal Imaging ,Multiple Myeloma ,Neoplasm Staging ,Nuclear Medicine ,Observer Variation ,Positron-Emission Tomography ,Prospective Studies ,Reproducibility of Results ,Tomography, X-Ray Computed ,Image Processing ,030218 nuclear medicine & medical imaging ,0302 clinical medicine ,Computer-Assisted ,Nuclear Medicine and Imaging ,hemic and lymphatic diseases ,Tomography ,General Medicine ,X-Ray Computed ,030220 oncology & carcinogenesis ,Fdg pet ct ,Radiology ,medicine.drug ,medicine.medical_specialty ,Visual interpretation ,Concordance ,IMPeTU ,03 medical and health sciences ,medicine ,Radiology, Nuclear Medicine and imaging ,In patient ,Bone ,neoplasms ,Image Interpretation ,Fluorodeoxyglucose ,business.industry ,Radiology, Nuclear Medicine and Imaging ,medicine.disease ,carbohydrates (lipids) ,Orthopedic surgery ,business ,Nuclear medicine ,Fractures - Abstract
FDG PET/CT is able to detect active disease in patients with multiple myeloma (MM) and can be helpful for staging and assessing therapy response, but no standard interpretation criteria have been proposed for the evaluation of FDG PET/CT in MM. A group of Italian nuclear medicine physicians and haematologists met to propose new visual interpretation criteria to standardize FDG PET/CT evaluation in MM patients (Italian Myeloma criteria for PET USe; IMPeTUs) and the reproducibility of these criteria was tested. This Italian multicentre protocol was set up as a subprotocol of EMN02, an international prospective multicentre trial of the European Myeloma Network. The criteria were agreed at multidisciplinary consensus meetings. They include a description of the metabolic state of the bone marrow (BM), number and site of focal PET-positive lesions, the number of osteolytic lesions, and the presence and site of extramedullary disease, paramedullary disease and fractures. A visual degree of uptake was defined for the target lesion and extramedullary lesions according to modified Deauville criteria. MM patients who had undergone FDG PET/CT at baseline (PET-0), after induction (PET-AI) and at the end of treatment (PET-EoT) were enrolled. The patients had been prospectively enrolled in EMN02 and their PET scans were a posteriori reinterpreted in a blinded independent central review process managed by WIDEN®. Five expert nuclear medicine physicians scored the scans according to the new criteria. A case was considered read when four out of the five reviewers completed the report. Concordance among reviewers on different metrics was calculated using Krippendorff’s alpha coefficient. A total of 17 consecutive patients were enrolled. On PET-0, the alpha coefficients for the BM score, the score for the hottest focal lesion, the number of focal lesions and the number of lytic lesions were 0.33 and 0.47, 0.40 and 0.32, respectively. On PET-AI, the alpha coefficients were 0.09 and 0.43, 0.22 and 0.21, respectively, and on PET-EoT, the alpha coefficients were 0.07, 0.28, 0.25 and 0.21, respectively. BM was generally difficult to score since grades 2 and 3 are difficult to discriminate. However, since neither of the two grades is related to BM myelomatous involvement, the difference was not clinically relevant. Agreement on focal lesion scores and on the number of focal lesions was good. The new visual criteria for interpreting FDG PET/CT imaging in MM patients, IMPeTUs, were found to be feasible in clinical practice.
- Published
- 2016
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