Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial
Sagar Lonial,Brendan M. Weiss,Saad Z. Usmani,Seema Singhal,Ajai Chari,Nizar J. Bahlis,Andrew Belch,Amrita Krishnan,Robert Vescio,Maria-Victoria Mateos,Amitabha Mazumder,Robert Z. Orlowski,Heather J. Sutherland,Joan Bladé,Emma C. Scott,Albert Oriol,Jesus G. Berdeja,Mecide Gharibo,Don A. Stevens,Richard Leblanc,Michael Sebag,Natalie S. Callander,Andrzej Jakubowiak,Darrell White,Javier de la Rubia,Paul G. Richardson,Steen Lisby,Huaibao Feng,Clarissa M. Uhlar,Imran Khan,Tahamtan Ahmadi,Peter M. Voorhees +31 more
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TLDR
Daratumumab monotherapy showed encouraging efficacy in heavily pretreated and refractory patients with multiple myeloma, with a favourable safety profile in this population of patients.About:
This article is published in The Lancet.The article was published on 2016-04-09 and is currently open access. It has received 680 citations till now. The article focuses on the topics: Daratumumab & Population.read more
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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
New developments in the treatment of multiple myeloma - clinical utility of daratumumab.
TL;DR: The potential upfront role of daratumumab has significant potential for increased minimal residual disease negativity and improved progression-free survival even in high-risk groups, and several trials are ongoing in the relapsed and upfront setting.
Journal ArticleDOI
Propensity score matching analysis to evaluate the comparative effectiveness of daratumumab versus real-world standard of care therapies for patients with heavily pretreated and refractory multiple myeloma.
Shaji Kumar,Brian G.M. Durie,Hareth Nahi,Ravi Vij,Meletios A. Dimopoulos,Efstathios Kastritis,Evangelos Terpos,Xavier Leleu,Meral Beksac,Hartmut Goldschmidt,Jens Hillengass,Zhuo Su,Brian Hutton,Chris Cameron,Imran Khan,Annette Lam +15 more
TL;DR: Propensity score matching (PSM) based on individual patient data (IPD) was conducted to compare overall survival (OS) and progression-free survival (PFS) for daratumumab versus real-world standard of care (SOC).
Journal ArticleDOI
Daratumumab Split First Versus Single Dosing Schedule Among Patients With Multiple Myeloma Treated in a US Community Oncology Setting: A Retrospective Observational Study.
TL;DR: Although the total administration time was longer among patients receiving a split first dose, the shorter day 1 infusion for this dosing schedule without increased infusion reactions may be an option for community oncology clinics.
Journal ArticleDOI
Monitoring the M-protein of multiple myeloma patients treated with a combination of monoclonal antibodies: the laboratory solution to eliminate interference.
Somayya Noori,Christie P. M. Verkleij,Marina Zajec,Pieter Langerhorst,Patricia W. C. Bosman,Yolanda B. de Rijke,Sonja Zweegman,Martijn M. VanDuijn,Theo M. Luider,Niels W.C.J. van de Donk,Joannes F M Jacobs +10 more
TL;DR: In this article, the authors evaluated two different methods to monitor M-protein responses in three MM patients, who received both daratumumab and nivolumab, and found that the m-protein can be distinguished from both t-mAbs by using a double hydrashift assay.
References
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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
Improved survival in multiple myeloma and the impact of novel therapies
Shaji Kumar,S. Vincent Rajkumar,Angela Dispenzieri,Martha Q. Lacy,Suzanne R. Hayman,Francis K. Buadi,Steven R. Zeldenrust,David Dingli,Stephen J. Russell,John A. Lust,Philip R. Greipp,Robert A. Kyle,Morie A. Gertz +12 more
TL;DR: Improved outcome of patients with myeloma in recent years is demonstrated, both in the relapsed setting as well as at diagnosis, both from time of diagnosis and the time of relapse.
Journal ArticleDOI
Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma
Abstr Act,Sagar Lonial,Meletios A. Dimopoulos,Antonio Palumbo,Darrell White,Sebastian Grosicki,Ivan Spicka,Adam Walter‑Croneck,Philippe Moreau,Maria-Victoria Mateos,Hila Magen,Andrew Belch,Donna E. Reece,Meral Beksac,Andrew Spencer,Heather Oakervee,Robert Z. Orlowski,Masafumi Taniwaki,Christoph Röllig,Hermann Einsele,Ka Lung Wu,Anil K. Singhal,Jesús F. San Miguel,Morio Matsumoto,Jessica Katz,Eric Bleickardt,Valerie Poulart,Kenneth C. Anderson,Paul G. Richardson +28 more
TL;DR: Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab, lenalidomide, and dexamethasone had a significant relative reduction of 30% in the risk of disease progression or death.
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.
Journal ArticleDOI
Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1
S. Vincent Rajkumar,Jean Luc Harousseau,Brian G.M. Durie,Kenneth C. Anderson,Meletios A. Dimopoulos,Robert A. Kyle,Joan Bladé,Paul G. Richardson,Robert Z. Orlowski,David S. Siegel,Sundar Jagannath,Thierry Facon,Hervé Avet-Loiseau,Sagar Lonial,Antonio Palumbo,Jeffrey A. Zonder,Heinz Ludwig,David H. Vesole,O. Sezer,Nikhil C. Munshi,Nikhil C. Munshi,Jesús F. San Miguel +21 more
TL;DR: It is proposed that future clinical trials in myeloma follow the guidelines for reporting results proposed in this manuscript, and detailed definitions for patient populations, lines of therapy, and specific endpoints are provided.
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Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma
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Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma
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Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors
Michel de Weers,Yu-Tzu Tai,Michael S. van der Veer,Joost M. Bakker,Tom Vink,Daniëlle C H Jacobs,Lukas A. Oomen,Matthias Peipp,Thomas Valerius,Jerry W. Slootstra,Tuna Mutis,Wim K. Bleeker,Kenneth C. Anderson,Henk M. Lokhorst,Jan G. J. van de Winkel,Jan G. J. van de Winkel,Paul W. H. I. Parren +16 more