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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

Authors :
Attal, Michel
Richardson, Paul G
Rajkumar, S Vincent
San-Miguel, Jesus
Beksac, Meral
Spicka, Ivan
Leleu, Xavier
Schjesvold, Fredrik
Moreau, Philippe
Dimopoulos, Meletios A
Huang, Jeffrey Shang-Yi
Minarik, Jiri
Cavo, Michele
Prince, H Miles
Macé, Sandrine
Corzo, Kathryn P
Campana, Frank
Le-Guennec, Solenn
Dubin, Franck
Anderson, Kenneth C
Attal, Michel
Richardson, Paul G.
Rajkumar, Vincent
San-Miguel, Jesus
Beksac, Meral
Spicka, Ivan
Leleu, Xavier
Schjesvold, Fredrik
Moreau, Philippe
Dimopoulos, Meletios A.
Huang, Jeffrey Shang-Yi
Minarik, Jiri
Cavo, Michele
Prince, H. Miles
Macé, Sandrine
Corzo, Kathryn P.
Campana, Frank
Le-Guennec, Solenn
Dubin, Franck
Anderson, Kenneth C.
Harrison, Simon
Janowski, Wojt
Kerridge, Ian
Spencer, Andrew
Delforge, Michel
Fostier, Karel
Vlummens, Philip
Wu, Ka Lung
Leblanc, Richard
Pavic, Michel
Sebag, Michael
Hajek, Roman
Maisnar, Vladimir
Pour, Ludek
Gregersen, Henrik
Benbouker, Lotfi
Caillot, Denis
Escoffre-Barbe, Martine
Facon, Thierry
Frenzel, Laurent
Hulin, Cyrille
Karlin, Lionel
Kolb, Brigitte
Pegourie, Brigitte
Perrot, Aurore
Tiab, Mourad
Vincent, Laure
Niederwieser, Dietger
Anagnostopoulos, Achilles
Delimpasi, Sosana
Kyrtsonis, Marie-Christine
Symeonidis, Anargyros
Illes, Arpad
Mikala, Gabor
Nagy, Zsolt
Bringen, Sara
Corradini, Paolo
Fabio, Ciceri
Lemoli, Roberto
Liberati, Anna
Nozzoli, Chiara
Zambello, Renato
Iida, Shinsuke
Ikeda, Takashi
Iyama, Satoshi
Matsumoto, Morio
Shimazaki, Chihiro
Sunami, Kazutaka
Suzuki, Kenshi
Uchiyama, Michihiro
Koh, Youngil
Kim, Kihyun
Lee, Jae Hoon
Min, Chang-Ki
Blacklock, Hillary
Goodman, Hugh
Neylon, Annette
Simpson, David
Grosicki, Sebastian
Jurczyszyn, Artur
Walter-Croneck, Adam
Warzocha, Krzysztof
Araujo, Luis
Moreira, Claudia
Doronin, Vadim
Mendeleeva, Larisa
Vorobyev, Vladimir
Vranovsky, Andrej
Alegre, Adrian
Gironella, Mercedes
Gonzalez Perez, Marta Sonia
Montes, Carmen
Ocio, Enrique
Rodriguez, Paula
Hardling, Mats
Lauri, Birgitta
Wang, Ming-Chung
Yeh, Su-Peng
Arat, Mutlu
Demirkan, Fatih
Gulbas, Zafer
Besisik, Sevgi Kalayoglu
Karadogan, Ihsan
Tuglular, Tulin
Unal, Ali
Vural, Filiz
Sive, Jonathan
Streetly, Matthew
Yong, Kwee
Tache, Jason
Source :
The Lancet; December 2019, Vol. 394 Issue: 10214 p2096-2107, 12p
Publication Year :
2019

Abstract

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.

Details

Language :
English
ISSN :
01406736 and 1474547X
Volume :
394
Issue :
10214
Database :
Supplemental Index
Journal :
The Lancet
Publication Type :
Periodical
Accession number :
ejs51561126
Full Text :
https://doi.org/10.1016/S0140-6736(19)32556-5