Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma
Antonio Palumbo,Asher Chanan-Khan,Katja Weisel,Ajay K. Nooka,Tamás Masszi,Meral Beksac,Ivan Spicka,Vania Hungria,Markus Munder,Maria-Victoria Mateos,Tomer M Mark,Ming Qi,Jordan M. Schecter,Himal Amin,Xiang Qin,William Deraedt,Tahamtan Ahmadi,Andrew Spencer,Pieter Sonneveld +18 more
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TLDR
Among patients with relapsed or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexamethasone resulted in significantly longer progression-free survival than borteonib and DexamethAsone alone and was associated with infusion-related reactions and higher rates of thrombocytopenia and neutropenia.Abstract:
BackgroundDaratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients with multiple myeloma, as well as in combination with bortezomib in patients with newly diagnosed multiple myeloma. MethodsIn this phase 3 trial, we randomly assigned 498 patients with relapsed or relapsed and refractory multiple myeloma to receive bortezomib (1.3 mg per square meter of body-surface area) and dexamethasone (20 mg) alone (control group) or in combination with daratumumab (16 mg per kilogram of body weight) (daratumumab group). The primary end point was progression-free survival. ResultsA prespecified interim analysis showed that the rate of progression-free survival was significantly higher in the daratumumab group than in the control group; the 12-month rate of progression-free survival was 60.7% in the daratumumab group versus 26.9% in the control group. After a median follow-up period ...read more
Citations
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Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 vs Physician's Choice of Therapy in the Long-Term Follow-Up of POLLUX, CASTOR, and EQUULEUS Clinical Trials for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Katja Weisel,Thomas Martin,Amrita Krishnan,Sundar Jagannath,Anil Londhe,Sandhya Nair,Joris Diels,Martin Vogel,Jordan M. Schecter,Arnob Banerjee,Jesus G. Berdeja,Tonia Nesheiwat,Ashraf Garrett,Keqin Qi,Satish Valluri,Saad Z. Usmani,Kwee Yong +16 more
TL;DR: In this paper, Ciltacabtagene autoleucel (cilta-cel) was evaluated in the single-arm CARTITUDE-1 trial for patients with relapsed or refractory multiple myeloma who are triple-class exposed to an immunomodulatory drug, proteasome inhibitor, and an anti-CD38 monoclonal antibody.
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Venous thromboembolism in relapsed or refractory multiple myeloma patients treated with lenalidomide plus dexamethasone.
Junghoon Shin,Je-Jung Lee,Ki-Hyun Kim,Chang-Ki Min,Jeong Ok Lee,Cheolwon Suh,Jin Seok Kim,Yoo Jin Lee,Sung-Soo Yoon,Jae-Cheol Jo,Ho Sup Lee,Soo Mee Bang +11 more
TL;DR: In conclusion, VTE occurred in 5–8% of RRMM patients treated with LD over 2 years, and early-onset VTE was a strong indicator of poor prognosis.
Journal ArticleDOI
Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE.
Maria-Victoria Mateos,Meletios A. Dimopoulos,Michele Cavo,Kenshi Suzuki,Stefan Knop,Chantal Doyen,Paulo Sérgio Lucio,Zsolt Nagy,Ludek Pour,Sebastian Grosicki,Andre H Crepaldi,Anna Marina Liberati,Philip Campbell,Sung-Soo Yoon,Genadi Iosava,Tomoaki Fujisaki,Mamta Garg,Shinsuke Iida,Joan Bladé,Jon Ukropec,Huiling Pei,Rian Van Rampelbergh,Anupa Kudva,Ming Qi,Jesús F. San-Miguel +24 more
TL;DR: The findings support the clinical benefit of D-VMP in transplant-ineligible NDMM patients enrolled in ALCYONE, regardless of frailty status, and a subgroup analysis of ALCyONE by patient frailtyStatus is presented.
Journal ArticleDOI
Advances in the Treatment of Relapsed and Refractory Multiple Myeloma in Patients with Renal Insufficiency: Novel Agents, Immunotherapies and Beyond.
Boris Bozic,Jens Rutner,Chang Zheng,Reinhard Ruckser,Flonza Selimi,Krysztina Racz,Martin Kocher,Georg Tatzreiter,Christian Sebesta +8 more
TL;DR: In this paper, new drugs have helped to widen the treatment options available for patients with renal impairment and refractory/relapsed multiple myeloma, since dose adjustments are unnecessary with carfilzomib as well as with panobinostat, elotuzumab, pomalidomide or daratumumab.
Journal ArticleDOI
Overall Survival With Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR): A Randomized, Open-Label, Phase III Trial
Pieter Sonneveld,Asher Chanan-Khan,Katja Weisel,Ajay K. Nooka,Tamás Masszi,Meral Beksac,Ivan Spicka,Vania Hungria,Markus Munder,Maria-Victoria Mateos,Tomer M Mark,Mark-David Levin,Tahamtan Ahmadi,Xiang Qin,W. Garvin Mayo,Xueliang Gai,Jodi L Carey,Robin Carson,Andrew Spencer +18 more
TL;DR: The Castor trial as mentioned in this paper showed that daratumumab plus bortezomib and dexamethasone (D-Vd) significantly prolonged progression-free survival in patients with relapsed or refractory multiple myeloma.
References
More filters
Journal ArticleDOI
A phase 2 study of bortezomib in relapsed, refractory myeloma.
Paul G. Richardson,Bart Barlogie,James R. Berenson,Seema Singhal,Sundar Jagannath,D. Irwin,S. Vincent Rajkumar,Gordan Srkalovic,Melissa Alsina,Raymond Alexanian,David S. Siegel,Robert Z. Orlowski,David J. Kuter,Steven Limentani,Stephanie J. Lee,Teru Hideshima,Dixie Lee Esseltine,Michael Kauffman,Julian Adams,David P. Schenkein,Kenneth C. Anderson +20 more
TL;DR: Bortezomib, a member of a new class of anticancer drugs, is active in patients with relapsed multiple myeloma that is refractory to conventional chemotherapy.
Journal ArticleDOI
International uniform response criteria for multiple myeloma
Brian G.M. Durie,J L Harousseau,Jesús F. San Miguel,J. Bladé,Bart Barlogie,Kenneth C. Anderson,Morie A. Gertz,Meletios A. Dimopoulos,Johan Westin,Pieter Sonneveld,Heinz Ludwig,G. Gahrton,Meral Beksac,John Crowley,Andrew Belch,M. Boccadaro,Ingemar Turesson,Douglas E. Joshua,David H. Vesole,Robert A. Kyle,Raymond Alexanian,Guido Tricot,M. Attal,Giampaolo Merlini,R. L. Powles,Paul G. Richardson,K. Shimizu,Patrizia Tosi,Gareth J. Morgan,S V Rajkumar +29 more
TL;DR: The European Group for Blood and Bone Marrow Transplant/International Bone Marrows Transplant Registry criteria have been expanded, clarified and updated to provide a new comprehensive evaluation system to adequately assess clinical outcomes in myeloma.
Journal ArticleDOI
International staging system for multiple myeloma.
Philip R. Greipp,Jesús F. San Miguel,Brian G.M. Durie,John Crowley,Bart Barlogie,Joan Bladé,Mario Boccadoro,J. Anthony Child,Hervé Avet-Loiseau,Robert A. Kyle,Juan J. Lahuerta,Heinz Ludwig,Gareth J. Morgan,R. L. Powles,Kazuyuki Shimizu,Chaim Shustik,Pieter Sonneveld,Patrizia Tosi,Ingemar Turesson,Jan Westin +19 more
TL;DR: The new International Staging System (ISS) is simple, based on easy to use variables (Sbeta2M and serum albumin), and recommended for early adoption and widespread use.
Journal ArticleDOI
Discrete sequential boundaries for clinical trials
K. K. Gordon Lan,David L. DeMets +1 more
TL;DR: In this article, the authors proposed a more flexible method to construct discrete sequential boundaries based on the choice of a function, a*(t), which characterizes the rate at which the error level ac is spent.
Journal ArticleDOI
Targeting CD38 with daratumumab monotherapy in multiple myeloma
Henk M. Lokhorst,Torben Plesner,Jacob P. Laubach,Hareth Nahi,Peter Gimsing,Markus Hansson,Monique C. Minnema,Ulrik Lassen,Ulrik Lassen,Jakub Krejcik,Antonio Palumbo,Niels W.C.J. van de Donk,Tahamtan Ahmadi,Imran Khan,Clarissa M. Uhlar,Jianping Wang,A. Kate Sasser,Nedjad Losic,Steen Lisby,Linda Basse,Nikolai Constantin Brun,Paul G. Richardson +21 more
TL;DR: Daratumumab monotherapy had a favorable safety profile and encouraging efficacy in patients with heavily pretreated and refractory myeloma, and no maximum tolerated dose was identified in part 1.
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