Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma
Antonio Palumbo,Asher Chanan-Khan,Katja Weisel,Ajay K. Nooka,Tamás Masszi,Meral Beksac,Ivan Spicka,Vania Hungria,Markus Munder,Maria-Victoria Mateos,Tomer M Mark,Ming Qi,Jordan M. Schecter,Himal Amin,Xiang Qin,William Deraedt,Tahamtan Ahmadi,Andrew Spencer,Pieter Sonneveld +18 more
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TLDR
Among patients with relapsed or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexamethasone resulted in significantly longer progression-free survival than borteonib and DexamethAsone alone and was associated with infusion-related reactions and higher rates of thrombocytopenia and neutropenia.Abstract:
BackgroundDaratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients with multiple myeloma, as well as in combination with bortezomib in patients with newly diagnosed multiple myeloma. MethodsIn this phase 3 trial, we randomly assigned 498 patients with relapsed or relapsed and refractory multiple myeloma to receive bortezomib (1.3 mg per square meter of body-surface area) and dexamethasone (20 mg) alone (control group) or in combination with daratumumab (16 mg per kilogram of body weight) (daratumumab group). The primary end point was progression-free survival. ResultsA prespecified interim analysis showed that the rate of progression-free survival was significantly higher in the daratumumab group than in the control group; the 12-month rate of progression-free survival was 60.7% in the daratumumab group versus 26.9% in the control group. After a median follow-up period ...read more
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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.
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