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
Citations
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Investigation into the interference of the monoclonal antibody daratumumab on the free light chain assay
TL;DR: While Dara can interfere with the IFE to determine clinical responses the FLC assay can be useful in patients who have abnormal FLC ratios prior to Dara therapy to determine responses especially in IgG-kappa Myeloma.
Journal ArticleDOI
Impact of Fc gamma receptor polymorphisms on efficacy and safety of daratumumab in relapsed/refractory multiple myeloma.
Niels W.C.J. van de Donk,Tineke Casneuf,Alessandro Di Cara,Paul W. H. I. Parren,Paul W. H. I. Parren,Paul W. H. I. Parren,Sonja Zweegman,Berris van Kessel,Henk M. Lokhorst,Saad Z. Usmani,Sagar Lonial,Paul G. Richardson,Christopher Chiu,Tuna Mutis,Inger S. Nijhof,A. Kate Sasser +15 more
TL;DR: This data indicates that vaccination against viral infections and autoimmune diseases is a viable treatment option for some types of rheumatoid arthritis.
Journal ArticleDOI
CD38: targeted therapy in multiple myeloma and therapeutic potential for solid cancers.
TL;DR: It is suggested that CD38 can be exploited to treat solid tumors by regulating the immunosuppressive microenvironment by reducing CD38+ immune suppressor cells.
Journal ArticleDOI
Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma
Cristina Gasparetto,Suzanne Lentzsch,Gary J. Schiller,Natalie S. Callander,Sascha A. Tuchman,Christine Chen,Darrell White,Rami Kotb,Heather J. Sutherland,Michael Sebag,Muhamed Baljevic,William I. Bensinger,Richard Leblanc,Chris Venner,Nizar J. Bahlis,Adriana C Rossi,Noa Biran,Heidi Sheehan,Jean-Richard Saint-Martin,Dane Van Domelen,Kazuharu Kai,Jatin P. Shah,Sharon Shacham,Michael Kauffman,Brea Lipe +24 more
TL;DR: SDd was well tolerated and its promising efficacy suggests that further study of this PI‐ and IMiD‐free regimen in RRMM patients who had at least one prior line of therapy including a PI and anIMiD but whose disease is naïve to daratumumab is warranted.
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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