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
The Impact of Tumor Heterogeneity on Diagnostics and Novel Therapeutic Strategies in Multiple Myeloma
TL;DR: The clinical impact of spatial heterogeneity on the efficacy of monoclonal antibodies and novel immunotherapies is described and combining molecular tests with imaging is recommended to improve risk prediction and monitoring of residual disease.
Journal ArticleDOI
Long-term CD38 saturation by daratumumab interferes with diagnostic myeloma cell detection.
Anna Oberle,Anna Brandt,Malik Alawi,Claudia Langebrake,Snjezana Janjetovic,Christine Wolschke,Kerstin Schütze,Peter Bannas,Nicolaus Kröger,Friedrich Koch-Nolte,Carsten Bokemeyer,Mascha Binder +11 more
TL;DR: In vitro and in vivo data are presented illustrating that interference of daratumumab with diagnostic CD38 antibodies in flow cytometry represents another practical issue relevant for the management of patients with multiple myeloma who have received CD38-directed treatment.
Journal ArticleDOI
Treatment of relapsed multiple myeloma: Evidence-based recommendations
Ceren Durer,Seren Durer,Sarah Lee,Rajshekhar Chakraborty,Mustafa Nadeem Malik,Abdul Rafae,Muhammad Abu Zar,Ahmad Kamal,Nathaniel Rosko,Christy J. Samaras,Jason Valent,Chakra P Chaulagain,Faiz Anwer +12 more
TL;DR: A review of FDA-approved regimens for RRMM patients is described and a paradigm in selecting subsequent treatment regimens is offered, focusing on patient specific morbidity, treatment toxicity, and disease-specific characteristics.
Journal ArticleDOI
Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).
C. Ola Landgren,Ajai Chari,Yael C Cohen,Andrew Spencer,Peter M. Voorhees,Jane Estell,Irwindeep Sandhu,Matthew W Jenner,Catherine D. Williams,Michele Cavo,Niels W.C.J. van de Donk,Meral Beksac,Philippe Moreau,Hartmut Goldschmidt,Steven Kuppens,Rajesh Bandekar,Pamela L. Clemens,Tobias Neff,Christoph Heuck,Ming Qi,Craig C. Hofmeister +20 more
TL;DR: In the CENTAURUS trial as mentioned in this paper, patients with intermediate-risk or high-risk multiple myeloma (SMM) were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules.
Journal ArticleDOI
Ubiquitin-activating enzyme inhibition induces an unfolded protein response and overcomes drug resistance in myeloma.
Junling Zhuang,Junling Zhuang,Fazal Shirazi,Ram Kumar Singh,Isere Kuiatse,Hua Wang,Hans C. Lee,Zuzana Berkova,Allison Berger,Marc L. Hyer,Nibedita Chattopadhyay,Sakeena Syed,Judy Qiuju Shi,Jie Yu,Vaishali Shinde,Stephen Tirrell,Richard J. Jones,Zhiqiang Wang,R. Eric Davis,Robert Z. Orlowski +19 more
TL;DR: The data support the conclusion that UAE inhibition could be an attractive strategy to move forward to the clinic for patients with relapsed and/or refractory multiple myeloma.
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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