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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Journal ArticleDOI
Management of multiple myeloma in the relapsed/refractory patient.
TL;DR: increasingly, it becomes important to consider the therapeutic options for the whole duration of the disease and integrate a systematic approach for the patient.
Journal ArticleDOI
Next-generation multiple myeloma treatment: a pharmacoeconomic perspective.
TL;DR: Current myeloma therapy is examined from a pharmacoeconomic perspective, the underlying reasons why cancer drugs are so expensive, the measures that are required to lower cost, and proposed potential ways in which costs can be reduced while still delivering high-quality care.
Journal ArticleDOI
Isatuximab plus pomalidomide/dexamethasone versus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma: ICARIA Phase III study design.
Paul G. Richardson,Michel Attal,Frank Campana,Solenn Le-Guennec,Ai-Min Hui,Marie-Laure Risse,Kathryn P. Corzo,Kenneth C. Anderson +7 more
TL;DR: The design of the Phase III ICARIA-MM study is described which will evaluate isatuximab in combination with pomalidomide (Pom) and low-dose dexamethasone (dex) (Poms/Dex) versus Pom/dex alone in RRMM.
Journal ArticleDOI
Pharmacokinetics of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma After Prior Proteasome Inhibitor and Immunomodulatory Drug Treatment.
Pamela L. Clemens,Xiaoyu Yan,Henk M. Lokhorst,Sagar Lonial,Nedjad Losic,Imran Khan,Richard Jansson,Tahamtan Ahmadi,Kristen Lantz,Honghui Zhou,Thomas A. Puchalski,Xu Steven Xu +11 more
TL;DR: The use of the recommended dose regimen of daratumumab to rapidly saturate target-mediated clearance during weekly dosing and maintain saturation when dosing every 2 or 4 weeks is supported.
Journal ArticleDOI
Daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma: final results from the phase 2 GEN501 and SIRIUS trials.
Saad Z. Usmani,Hareth Nahi,Torben Plesner,Brendan M. Weiss,Nizar J. Bahlis,Andrew Belch,Peter M. Voorhees,Jacob P. Laubach,Niels W.C.J. van de Donk,Tahamtan Ahmadi,Clarissa M. Uhlar,Jianping Wang,Huaibao Feng,Ming Qi,Paul G. Richardson,Sagar Lonial +15 more
TL;DR: In this analysis, daratumumab 16 mg/kg monotherapy showed durable responses and there were no new safety concerns with longer follow-up of these two studies.
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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