Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study

M Attal; PG Richardson; SV Rajkumar; J San-Miguel; M Beksac; I Spicka; X Leleu; F Schjesvold; P Moreau; MA Dimopoulos; JSY Huang; J Minarik; M Cavo; HM Prince; S Macé; KP Corzo; F Campana; S Le-Guennec; F Dubin; KC Anderson; V Rajkumar; MA Dimopoulos; S Harrison; W Janowski; I Kerridge; A Spencer; M Delforge; K Fostier; P Vlummens; KL Wu; R Leblanc; M Pavic; M Sebag; R Hajek; V Maisnar; L Pour; H Gregersen; L Benbouker; D Caillot; M Escoffre-Barbe; T Facon; L Frenzel; C Hulin; L Karlin; B Kolb; B Pegourie; A Perrot; M Tiab; L Vincent; D Niederwieser; A Anagnostopoulos; S Delimpasi; MC Kyrtsonis; A Symeonidis; A Illes; G Mikala; Z Nagy; S Bringen; P Corradini; C Fabio; R Lemoli; A Liberati; C Nozzoli; R Zambello; S Iida; T Ikeda; S Iyama; M Matsumoto; C Shimazaki; K Sunami; K Suzuki; M Uchiyama; Y Koh; K Kim; JH Lee; CK Min; H Blacklock; H Goodman; A Neylon; D Simpson; S Grosicki; A Jurczyszyn; A Walter-Croneck; K Warzocha; L Araujo; C Moreira; V Doronin; L Mendeleeva; V Vorobyev; A Vranovsky; A Alegre; M Gironella; MS Gonzalez Perez; C Montes; E Ocio; P Rodriguez; M Hardling; B Lauri

Journal article

Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study

M Attal, PG Richardson, SV Rajkumar, J San-Miguel, M Beksac, I Spicka, X Leleu, F Schjesvold, P Moreau, MA Dimopoulos, JSY Huang, J Minarik, M Cavo, HM Prince, S Macé, KP Corzo, F Campana, S Le-Guennec, F Dubin, KC Anderson Show all

Lancet | ELSEVIER SCIENCE INC | Published : 2019

DOI: 10.1016/S0140-6736(19)32556-5

Abstract

Background: Isatuximab is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone. The aim of this study was to determine the progression-free survival benefit of isatuximab plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. Methods: We did a randomised, multicentre, open-label, phase 3 study at 102 hospitals in 24 co..

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