1. 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
- Author
-
Attal, M. Richardson, P.G. Rajkumar, S.V. San-Miguel, J. Beksac, M. Spicka, I. Leleu, X. Schjesvold, F. Moreau, P. Dimopoulos, M.A. Huang, J.S.-Y. Minarik, J. Cavo, M. Prince, H.M. Macé, S. Corzo, K.P. Campana, F. Le-Guennec, S. Dubin, F. Anderson, K.C. Richardson, P.G. Rajkumar, V. Dimopoulos, M.A. Corzo, K.P. Harrison, S. Janowski, W. Kerridge, I. Spencer, A. Delforge, M. Fostier, K. Vlummens, P. Wu, K.L. Leblanc, R. Pavic, M. Sebag, M. Hajek, R. Maisnar, V. Pour, L. Gregersen, H. Benbouker, L. Caillot, D. Escoffre-Barbe, M. Facon, T. Frenzel, L. Hulin, C. Karlin, L. Kolb, B. Pegourie, B. Perrot, A. Tiab, M. Vincent, L. Niederwieser, D. Anagnostopoulos, A. Delimpasi, S. Kyrtsonis, M.-C. Symeonidis, A. Illes, A. Mikala, G. Nagy, Z. Bringen, S. Corradini, P. Fabio, C. Lemoli, R. Liberati, A. Nozzoli, C. Zambello, R. Iida, S. Ikeda, T. Iyama, S. Matsumoto, M. Shimazaki, C. Sunami, K. Suzuki, K. Uchiyama, M. Koh, Y. Kim, K. Lee, J.H. Min, C.-K. Blacklock, H. Goodman, H. Neylon, A. Simpson, D. Grosicki, S. Jurczyszyn, A. Walter-Croneck, A. Warzocha, K. Araujo, L. Moreira, C. Doronin, V. Mendeleeva, L. Vorobyev, V. Vranovsky, A. Alegre, A. Gironella, M. Gonzalez Perez, M.S. Montes, C. Ocio, E. Rodriguez, P. Hardling, M. Lauri, B. Wang, M.-C. Yeh, S.-P. Arat, M. Demirkan, F. Gulbas, Z. Besisik, S.K. Karadogan, I. Tuglular, T. Unal, A. Vural, F. Sive, J. Streetly, M. Yong, K. Tache, J.
- 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 countries in Europe, North America, and the Asia-Pacific regions. Eligible participants were adult patients with relapsed and refractory multiple myeloma who had received at least two previous lines of treatment, including lenalidomide and a proteasome inhibitor. Patients were excluded if they were refractory to previous treatment with an anti-CD38 monoclonal antibody. We randomly assigned patients (1:1) to either isatuximab 10 mg/kg plus pomalidomide 4 mg plus dexamethasone 40 mg (20 mg for patients aged ≥75 years), or pomalidomide 4 mg plus dexamethasone 40 mg. Randomisation was done using interactive response technology and stratified according to the number of previous lines of treatment (2–3 vs >3) and age (
- Published
- 2019