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

Attal, Michel; Richardson, Paul; Rajkumar, S.; San-Miguel, Jesus; BEKSAÇ, MERAL; Spicka, Ivan; Leleu, Xavier; Schjesvold, Fredrik; Moreau, Philippe; Dimopoulos, Meletios; Huang, Jeffrey; Minarik, Jiri; Cavo, Michele; Prince, H.; Mace, Sandrine; Corzo, Kathryn; Campana, Frank; Le-Guennec, Solenn; Dubin, Franck; Anderson, Kenneth

doi:10.1016/s0140-6736(19)32556-5

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

Attal M., Richardson P. G., Rajkumar S. V., San-Miguel J., BEKSAÇ M., Spicka I., ...More

LANCET, vol.394, no.10214, pp.2096-2107, 2019 (SCI-Expanded, Scopus)

Publication Type: Article / Article
Volume: 394 Issue: 10214
Publication Date: 2019
Doi Number: 10.1016/s0140-6736(19)32556-5
Journal Name: LANCET
Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
Page Numbers: pp.2096-2107
Ankara University Affiliated: Yes

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.