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13 p, 471.4 KB |
Overall Survival with Daratumumab, Lenalidomide, and Dexamethasone in Previously Treated Multiple Myeloma (POLLUX) : A Randomized, Open-Label, Phase III Trial
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Dimopoulos, Meletios (National and Kapodistrian University of Athens) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Nahi, Hareth (Department of Medicine. Karolinska University) ;
San-Miguel, J (Clínica Universidad de Navarra) ;
Bahlis, Nizar J. (University of Calgary) ;
Usmani, S. Z (Memorial Sloan Kettering Cancer Center) ;
Rabin, Neil (Department of Haematology. University College London Hospitals NHS Trust) ;
Orlowski, Robert Z. (Department of Lymphoma and Myeloma. The University of Texas) ;
Suzuki, Kenshi (Department of Hematology. Japanese Red Cross Medical Center) ;
Plesner, Torben (University of Southern Denmark) ;
Yoon, Sung Soo (Department of Internal Medicine. Seoul National University) ;
Ben Yehuda, Dina (Hematology Department. Hebrew University) ;
Richardson, Paul G. (Dana-Farber Cancer Institute (Estats Units d'Amèrica)) ;
Goldschmidt, Hartmut (Heidelberg University Hospital (Alemanya)) ;
Reece, Donna (Department of Medical Oncology and Hematology. Princess Margaret Cancer Centre) ;
Ahmadi, Tahamtan (Genmab US (Estats Units d'Amèrica)) ;
Qin, Xiang (Janssen Research & Development (Xina)) ;
Garvin Mayo, Wendy (Janssen Research & Development (Estats Units d'Amèrica)) ;
Gai, Xue (Janssen Research & Development (Estats Units d'Amèrica)) ;
Carey, Jodi (Janssen Research & Development (Estats Units d'Amèrica)) ;
Carson, Robin (Janssen Research & Development (Estats Units d'Amèrica)) ;
Moreau, Philippe (Hematology Department. University Hospital Hôtel-Dieu)
PURPOSEWith the initial analysis of POLLUX at a median follow-up of 13. 5 months, daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly prolonged progression-free survival versus lenalidomide and dexamethasone (Rd) alone in patients with relapsed or refractory multiple myeloma (RRMM). [...]
2023 -  10.1200/JCO.22.00940
Journal of Clinical Oncology, Vol. 41 Núm. 8 (october 2023) , p. 1590-1599
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11 p, 396.3 KB |
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.. (Department of Medical Oncology. Harvard Medical School) ;
Schjesvold, Fredrik (University of Oslo) ;
Weisel, Katja (University Medical Center Hamburg-Eppendorf) ;
Moreau, Philippe (University Hospital Hôtel-Dieu) ;
Anderson, Larry D. (University of Texas Southwestern Medical Center) ;
White, Darrell (Dalhousie University and Queen Elizabeth II Health Sciences Centre) ;
Rodriguez-Otero, Paula (Clínica Universidad de Navarra) ;
Sonneveld, Pieter (Erasmus MC Cancer Institute) ;
Engelhardt, Monika (Universitätsklinikum Freiburg) ;
Jenner, Matthew (University Hospital Southampton NHS Foundation Trust (Regne Unit)) ;
Corso, Alessandro (Hospital of Legnano) ;
Dürig, Jan (University Hospital Essen (Alemanya)) ;
Pavic, Michel (Centre Hospitalier Universitaire De Sherbrooke) ;
Salomo, Morten (Copenhagen University Hospital) ;
Beksac, Meral (Ankara University) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Lindsay, Jindriska (East Kent Hospitals University NHS Foundation Trust) ;
Liberati, Anna Marina (University of Perugia) ;
Galli, Monica (Ospedale Papa Giovanni XXIII. U.O. di Ematologia) ;
Robak, Pawel (Medical University of Lodz) ;
Larocca, Alessandra (A.O.U. Citta della Salute e della Scienza di Torino) ;
Yagci, Munci (Gazi University Medical Faculty) ;
Vural, Filiz (Ege University) ;
Kanate, Abraham (West Virginia University) ;
Jiang, Ruiyun (Bristol Myers Squibb) ;
Grote, Lara (Bristol Myers Squibb) ;
Peluso, Teresa (Celgene International Sàrl. a Bristol-Myers Squibb Company) ;
Dimopoulos, Meletios (National and Kapodistrian University of Athens)
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. [...]
2022 - 10.1111/ejh.13706
European Journal of Haematology, Vol. 108 Núm. 1 (january 2022) , p. 73-83
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3.
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16 p, 1.0 MB |
Pomalidomide, Bortezomib, and Dexamethasone in Lenalidomide-Pretreated Multiple Myeloma : A Subanalysis of OPTIMISMM by Frailty and Bortezomib Dose Adjustment
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Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Dimopoulos, Meletios (National and Kapodistrian University) ;
Schjesvold, Fredrik (University of Oslo) ;
Beksac, Meral (Ankara Üniversitesi Tip Fakültes) ;
Facon, Thierry (Hôpital Claude Huriez CHU de Lille) ;
Dhanasiri, Sujith (Celgene International Sàrl. a Bristol-Myers Squibb Company (Suïssa)) ;
Guo, Shien (Evidera) ;
Mu, Yutian (Evidera) ;
Hong, Kevin (Bristol Myers Squibb) ;
Gentili, Christian (Bristol Myers Squibb) ;
Galli, Mónica (ASST Papa Giovanni XXIII) ;
Yagci, Munci (Gazi University) ;
Larocca, Alessandra (University of Torino) ;
Richardson, Paul (Dana-Farber Cancer Institute (Estats Units d'Amèrica)) ;
Weisel, Katja (University Medical Center Hamburg-Eppendorf (Alemanya))
Introduction: A proportion of patients with multiple myeloma (MM) are older and/or have comorbidities, requiring dose adjustments. Data from OPTIMISMM (NCT01734928) supported the use of pomalidomide, bortezomib, and dexamethasone (PVd) for treating relapsed/refractory MM. [...]
2023 - 10.1016/j.clml.2023.10.009
Clinical Lymphoma, Myeloma & Leukemia, 2023
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9 p, 1.5 MB |
Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma : updated results from IKEMA, a randomized Phase 3 study
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Martin, Thomas (University of California at San Francisco, USA) ;
Dimopoulos, Meletios (University of Athens, Greece) ;
Mikhael, Joseph (Translational Genomics Research Institute. City of Hope Cancer Center, Phoenix, USA) ;
Yong, Kwee (University College Hospital, London, UK) ;
Capra, Marcelo (Centro Integrado de Hematologia e Oncologia. Hospital Mãe de Deus, Porto Alegre, Brazil) ;
Facon, Thierry (Lille University Hospital, France) ;
Hajek, Roman (University of Ostrava, Czech Republic) ;
Špička, Ivan (Department of Hematology. 1st Faculty of Medicine. Charles University and General Hospital, Prague, Czech Republic) ;
Baker, Ross (Murdoch University, Perth, Australia) ;
Kim, Kihyun (Sungkyunkwan University School of Medicine, Seoul, South Korea) ;
Martinez, Gracia (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil) ;
Min, Chang-Ki (The Catholic University of Korea) ;
Pour, Ludek (University Hospital Brno (República Txeca)) ;
Leleu, Xavier (Service d'Hématologie et Thérapie Cellulaire. CHU and CIC Inserm, France) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Koh, Youngil (Seoul National University Hospital, Seoul, South Korea) ;
Suzuki, Kenshi (Japanese Red Cross Medical Center, Tokyo, Japan) ;
Casca, France (Ividata Life Science, Levallois-Perret, France) ;
Macé, Sandrine (Sanofi, R&D, Chilly-Mazarin, France) ;
Risse, Marie-Laure (Sanofi, R&D, Vitry-sur-Seine, France) ;
Moreau, Philippe (University Hospital Hôtel-Dieu, Nantes, France)
Longer-term outcomes with the anti-CD38 antibody isatuximab in combination with carfilzomib-dexamethasone (Isa-Kd) were evaluated in the randomized Phase 3 trial IKEMA (NCT03275285), in a prespecified, follow-up analysis of progression-free survival (PFS, primary study endpoint), final complete response (CR) using Hydrashift Isa immunofixation assay, minimal residual disease (MRD) negativity, and safety. [...]
2023 - 10.1038/s41408-023-00797-8
Blood Cancer Journal, Vol. 13 Núm. 1 (december 2023)
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20 p, 525.5 KB |
Managing hematological cancer patients during the COVID-19 pandemic : an ESMO-EHA Interdisciplinary Expert Consensus
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Buske, Christian (University Hospital of Ulm (Alemanya)) ;
Dreyling, M. (Department of Medicine III at LMU Hospital) ;
Álvarez Larrán, Alberto (Institut d'Investigacions Biomèdiques August Pi i Sunyer) ;
Apperley, Jane (Imperial College London) ;
Arcaini, Luca (University of Pavia) ;
Besson, Caroline (UVSQ. Inserm. CESP) ;
Bullinger, Lars (Charité - Universitätsmedizin Berlin) ;
Corradini, Paolo (University of Milan) ;
Della Porta, Matteo Giovanni (Humanitas University) ;
Dimopoulos, Meletios (National and Kapodistrian University of Athens) ;
D'Sa, Shirley (University College London Hospitals NHS Foundation Trust) ;
Eich, H.T. (University of Muenster) ;
Foà, R. (Sapienza University) ;
Ghia, P. (Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele) ;
da Silva, M.G. (Portuguese Institute of Oncology) ;
Gribben, J. (Queen Mary University of London) ;
Hajek, Roman (University of Ostrava) ;
Harrison, C. (Guy's and St Thomas' NHS Foundation Trust) ;
Heuser, M. (Hannover Medical School) ;
Kiesewetter, Barbara (Medical University of Vienna) ;
Kiladjian, Jean-Jacques (Université de Paris) ;
Kroeger, Nicolaus (University Hospital Hamburg-Eppendorf) ;
Moreau, Philippe (University Hospital Hotel-Dieu) ;
Passweg, Jakob R. (University Hospital Basel (Basilea, Suïssa)) ;
Peyvandi, Flora (University of Milan) ;
Rea, Delphine (Hôpital Saint-Louis) ;
Ribera, Jose-Maria (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Robak, Tadeusz (Medical University of Lodz) ;
San-Miguel, J (Clínica Universidad de Navarra) ;
Santini, Valeria (University of Florence) ;
Sanz, G. (CIBERONC. IS Carlos III) ;
Sonneveld, P. (Erasmus MC Cancer Institute) ;
Von Lilienfeld-Toal, M. (Hans Knöll Institute) ;
Wendtner, Clemens-Martin (Ludwig-Maximilian University) ;
Pentheroudakis, G. (European Society for Medical Oncology) ;
Passamonti, Francesco (University of Insubria)
Background: The COVID-19 pandemic has created enormous challenges for the clinical management of patients with hematological malignancies (HMs), raising questions about the optimal care of this patient group. [...]
2022 - 10.1016/j.esmoop.2022.100403
ESMO open, Vol. 7 Núm. 2 (april 2022) , p. 100403
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10 p, 1.8 MB |
Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or Refractory Multiple Myeloma : Updated Overall Survival, Safety, and Subgroups
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Orlowski, Robert Z. (Department of Lymphoma and Myeloma. The University of Texas M.D. Anderson Cancer Center) ;
Moreau, Philippe (Department of Hematology. University Hospital Hotel-Dieu) ;
Niesvizky, Ruben (Department of Medical Oncology. Myeloma Center. New York Presbyterian Hospital-Weill Cornell Medical Center) ;
Ludwig, Heinz (Wilhelminen Cancer Research Institute (Viena, Àustria)) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Chng, Wee Joo (Department of Hematology Oncology. National University of Singapore) ;
Goldschmidt, Hartmut (Department of Hematology Oncology. Heidelberg University Clinic and the National Center of Tumor Diseases) ;
Yang, Zhao (Department of Biostatistics. Amgen. Inc) ;
Kimball, Amy S. (Department of Clinical Research. Amgen. Inc) ;
Dimopoulos, Meletios (Department of Clinical Therapeutics. University Athens School of Medicine) ;
Universitat Autònoma de Barcelona
Introduction: The phase III RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma (ENDEAVOR) trial showed significantly improved progression-free survival and overall survival (OS) with carfilzomib (56 mg/m) and dexamethasone (Kd56) versus bortezomib and Kd56 (Vd) in patients with relapsed or refractory multiple myeloma (RRMM). [...]
2019 - 10.1016/j.clml.2019.04.018
Clinical Lymphoma, Myeloma & Leukemia, Vol. 19 Núm. 8 (august 2019) , p. 522-530.e1
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13 p, 861.9 KB |
Ixazomib as postinduction maintenance for patients with newly diagnosed multiple myeloma not undergoing autologous stem cell transplantation : The phase III TOURMALINE-MM4 trial
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Dimopoulos, Meletios (The National and Kapodistrian University of Athens) ;
Špička, I. (Charles University. Faculty of Medicine in Hradec Králové) ;
Quach, H. (St Vincent's Hospital (Sydney)) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Hájek, R. (Department of Hemato-oncology. University Hospital Ostrava. University of Ostrava. Faculty of Medicine) ;
Garg, M. (Leicester General Hospital (Leicester, Regne Unit)) ;
Beksac, M. (Department of Hematology. Ankara University) ;
Bringhen, S. (Division of Hematology. University of Torino. Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino) ;
Katodritou, E. (Department of Hematology. Theagenion Cancer Hospital) ;
Chng, W. J. (Department of Hematology-Oncology. National University Cancer Institute. National University Health System. Yong Loo Lin School of Medicine. Cancer Science Institute of Singapore. National University of Singapore) ;
Leleu, Xavier (Pôle Régional de Cancérologie. Department of Haematology. Centre Hospitalier Universitaire La Milétrie-Poitiers) ;
Iida, S. (Department of Hematology and Oncology. Nagoya City University. Graduate School of Medical Sciences) ;
Mateos, M. V. (Hospital Universitario de Salamanca. Centro de Investigación del Cáncer) ;
Morgan, G. (Perlmutter Cancer Center. NYU Langone Health) ;
Vorog, A. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited) ;
Labotka, R. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited) ;
Wang, B. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited) ;
Palumbo, A. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited) ;
Lonial, S. (Department of Hematology and Medical Oncology. Winship Cancer Institute of Emory University) ;
Universitat Autònoma de Barcelona
PURPOSE Maintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. [...]
2020 - 10.1200/JCO.20.02060
Journal of Clinical Oncology, Vol. 38 Núm. 34 (january 2020) , p. 4030-4041
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12 p, 1.8 MB |
Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option : a cross-study comparison of the CANDOR and EQUULEUS studies
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Leleu, Xavier (Service d'Hématologie et Thérapie cellulaire. CHU and Inserm) ;
Beksac, M. (Department of Hematology. Ankara University) ;
Chou, T. (Niigata Cancer Center Hospital) ;
Dimopoulos, Meletios (Hematology and Medical Oncology. Department of Clinical Therapeutics. National and Kapodistrian University of Athens School of Medicine) ;
Yoon, S. S. (Department of Internal Medicine. Seoul National University) ;
Prince, H. M. (Epworth Healthcare and Sir Peter MacCallum Department of Oncology. University of Melbourne) ;
Pour, L. (University Hospital Brno (República Txeca)) ;
Shelekhova, T. (Clinic of Professional Pathology) ;
Chari, Ajai (Icahn School of Medicine at Mount Sinai (Nova York, Estats Units d'Amèrica). Tisch Cancer Institute) ;
Khurana, M. (Clinical Development. Oncology. Amgen Inc) ;
Zhang, J. (Global Biostatistical Science. Amgen Inc) ;
Obreja, M. (Global Biostatistical Science. Amgen Inc) ;
Qi, M. (Hematology and Oncology. Janssen Research and Development. LLC) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Siegel, D. (John Theurer Cancer Center. Hackensack University Medical Center) ;
Universitat Autònoma de Barcelona
The regimen of carfilzomib, daratumumab, and dexamethasone (KdD) shows activity in patients with relapsed/refractory multiple myeloma. KdD at the twice-weekly 56 mg/m carfilzomib dose (KdD56) was used in the randomized phase 3 CANDOR study (NCT03158688), whereas KdD at the once-weekly 70 mg/m carfilzomib dose (KdD70) was used in the phase 1 b EQUULEUS study (NCT01998971). [...]
2020 - 10.1080/10428194.2020.1832672
Leukemia and Lymphoma, 2020
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10 p, 667.7 KB |
Daratumumab, lenalidomide, and dexamethasone in relapsed/refractory myeloma : a cytogenetic subgroup analysis of POLLUX
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Kaufman, J. L. (Winship Cancer Institute. Emory University) ;
Dimopoulos, Meletios (The National and Kapodistrian University of Athens) ;
White, D. (Dalhousie University and Queen Elizabeth II Health Sciences Centre) ;
Benboubker, L. (Service d'Hématologie et Thérapie Cellulaire. Hôpital Bretonneau. Centre Hospitalier Régional Universitaire) ;
Cook, G. (St James's Institute of Oncology. Leeds Teaching Hospitals National Health Service Trust and University of Leeds) ;
Leiba, M. (Assuta Ashdod University Hospital. Faculty of Health Science Ben-Gurion University of the Negev) ;
Morton, J. (Icon Cancer Care) ;
Joy Ho, P. (Institute of Haematology. Royal Prince Alfred Hospital) ;
Kim, K. (Department of Medicine. Samsung Medical Center. Sungkyunkwan University School of Medicine) ;
Takezako, N. (Department of Hematology. National Hospital Organization Disaster Medical Center of Japan) ;
Moreau, Philippe (Hematology. University Hospital Hôtel-Dieu) ;
Sutherland, H. J. (Leukemia/Bone Marrow Transplant Program. University of British Columbia) ;
Magen, H. (Department of Hematology Chaim Sheba Medical Center. Ramat-Gan. Sackler Faculty of Medicine. Tel Aviv University) ;
Iida, S. (Department of Hematology and Oncology. Nagoya City University Graduate School of Medical Sciences) ;
Kim, J. S. (Yonsei University College of Medicine. Severance Hospital) ;
Miles Prince, H. (Cabrini Hospital. Epworth HealthCare and Sir Peter MacCallum Department of Oncology. University of Melbourne) ;
Cochrane, T. (Gold Coast University Hospital and Griffiths University) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Bahlis, N. J. (University of Calgary. Arnie Charbonneau Cancer Institute) ;
Chari, Ajai (Icahn School of Medicine at Mount Sinai) ;
O'Rourke, L. (Janssen Research & Development) ;
Trivedi, S. (Janssen Research & Development) ;
Casneuf, T. (Janssen Research & Development) ;
Krevvata, M. (Janssen Research & Development) ;
Ukropec, J. (Janssen Global Medical Affairs) ;
Kobos, R. (Janssen Research & Development) ;
Avet-Loiseau, Hervé (Unite de Genomique du Myelome. IUC-Oncopole) ;
Usmani, S. Z. (Levine Cancer Institute/Atrium Health) ;
San-Miguel, J. (Clínica Universidad de Navarra. Centro de Investigación Médica Aplicada) ;
Universitat Autònoma de Barcelona
High cytogenetic risk abnormalities confer poor outcomes in multiple myeloma patients. In POLLUX, daratumumab/lenalidomide/dexamethasone (D-Rd) demonstrated significant clinical benefit versus lenalidomide/dexamethasone (Rd) in relapsed/refractory multiple myeloma (RRMM) patients. [...]
2020 - 10.1038/s41408-020-00375-2
Blood Cancer Journal, Vol. 10 Núm. 11 (january 2020) , p. 111
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11 p, 1.4 MB |
Carfilzomib and dexamethasone versus eight cycles of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma : an indirect comparison using data from the phase 3 ENDEAVOR and CASTOR trials
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Weisel, Katja (Department of Hematology. Oncology. Immunology. Rheumatology. and Pulmonology. Medical Clinic II) ;
Majer, Istvan (Amgen Europe GmbH) ;
DeCosta, Lucy (Amgen Ltd) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Goldschmidt, Hartmut (Internal Medicine V and National Center of Tumor Diseases. University Clinic Heidelberg) ;
Ludwig, Heiz (Wilhelminen Cancer Research Institute (Viena, Àustria)) ;
Campioni, Marco (Amgen Europe GmbH) ;
Szabo, Zsolt (Amgen Europe GmbH) ;
Dimopoulos, Meletios (School of Medicine. National and Kapodistrian University of Athens. Alexandra Hospital) ;
Universitat Autònoma de Barcelona
In ENDEAVOR, carfilzomib and dexamethasone (Kd56) demonstrated significant improvement in progression-free survival (PFS) compared with bortezomib and dexamethasone (Vd). Both agents were administered until disease progression; the EU label for Vd, however, stipulates a maximum of eight treatment cycles. [...]
2020 - 10.1080/10428194.2019.1648806
Leukemia and Lymphoma, Vol. 61 Núm. 1 (february 2020) , p. 37-46
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