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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Bridging the Divide: An Onco-Nephrologic Approach to the Monoclonal Gammopathies of Renal Significance
TL;DR: An "onco-nephrologic" approach to the MGRS disorders is presented by highlighting recent advances in lymphoma and multiple myeloma that can be used in the evaluation and management of these patients.
Journal ArticleDOI
Upregulation of CD38 expression on multiple myeloma cells by novel HDAC6 inhibitors is a class effect and augments the efficacy of daratumumab.
Estefanía García-Guerrero,Ralph Götz,Sören Doose,Markus Sauer,Alfonso Rodríguez-Gil,Thomas Nerreter,K. Martin Kortüm,José A. Pérez-Simón,Hermann Einsele,Michael Hudecek,Sophia Danhof +10 more
TL;DR: A proof-of-concept illustrates the potential benefit of combining HDAC6 inhibitors and CD38-directed immunotherapy for MM treatment and observes that combining ricolinostat with daratumumab induced enhanced lysis of MM cells.
Journal ArticleDOI
The Advent of CAR T-Cell Therapy for Lymphoproliferative Neoplasms: Integrating Research Into Clinical Practice.
Marco Cerrano,Marco Ruella,Miguel-Angel Perales,Candida Vitale,Danilo Faraci,Luisa Giaccone,Marta Coscia,Molly Maloy,Miriam Sanchez-Escamilla,Hesham Elsabah,Afraa M. Fadul,Enrico Maffini,Gianfranco Pittari,Benedetto Bruno +13 more
TL;DR: This review will focus on the major clinical trials of CAR T cells in B-cell malignancies, including those leading to the first FDA approvals, and on the new settings in which these constructs are being tested.
Journal ArticleDOI
Blood Transfusion Management for Patients Treated With Anti-CD38 Monoclonal Antibodies.
Guido Lancman,Suzanne Arinsburg,Jeffrey S. Jhang,Hearn Jay Cho,Sundar Jagannath,Deepu Madduri,Samir Parekh,Joshua Richter,Ajai Chari +8 more
TL;DR: The pathophysiology of this phenomenon is summarized, the clinical data reported to date are examined, currently available methods to resolve this issue are described, and a guide to clinical management of blood transfusions for patients receiving anti-CD38 monoclonal antibodies is provided.
Journal ArticleDOI
The JAK-STAT pathway regulates CD38 on myeloma cells in the bone marrow microenvironment: therapeutic implications
Daisuke Ogiya,Daisuke Ogiya,Jiye Liu,Hiroto Ohguchi,Keiji Kurata,Mehmet Kemal Samur,Yu-Tzu Tai,Sophia Adamia,Kiyoshi Ando,Teru Hideshima,Kenneth C. Anderson +10 more
TL;DR: CD38 expression on MM cells in the BM microenvironment is regulated by both STAT1 and STAT3, and inhibition of JAK-STAT3 pathway represents a novel therapeutic option to enhance CD38 expression and anti-CD38 MoAb-mediated MM cytotoxicity.
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, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors
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