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
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Michel Attal, Paul G Richardson, S Vincent Rajkumar, Jesus San-Miguel, Meral Beksac, Ivan Spicka, Xavier Leleu, Fredrik Schjesvold, Philippe Moreau, Meletios A Dimopoulos, Jeffrey Shang-Yi Huang, Jiri Minarik, Michele Cavo, H Miles Prince, Sandrine Macé, Kathryn P Corzo, Frank Campana, Solenn Le-Guennec, Franck Dubin, Kenneth C Anderson, Paul G. Richardson, Vincent Rajkumar, Meletios A. Dimopoulos, H. Miles Prince, Kathryn P. Corzo, Kenneth C. Anderson, Simon Harrison, Wojt Janowski, Ian Kerridge, Andrew Spencer, Michel Delforge, Karel Fostier, Philip Vlummens, Ka Lung Wu, Richard Leblanc, Michel Pavic, Michael Sebag, Roman Hajek, Vladimir Maisnar, Ludek Pour, Henrik Gregersen, Lotfi Benbouker, Denis Caillot, Martine Escoffre-Barbe, Thierry Facon, Laurent Frenzel, Cyrille Hulin, Lionel Karlin, Brigitte Kolb, Brigitte Pegourie, Aurore Perrot, Mourad Tiab, Laure Vincent, Dietger Niederwieser, Achilles Anagnostopoulos, Sosana Delimpasi, Marie-Christine Kyrtsonis, Anargyros Symeonidis, Arpad Illes, Gabor Mikala, Zsolt Nagy, Sara Bringen, Paolo Corradini, Ciceri Fabio, Roberto Lemoli, Anna Liberati, Chiara Nozzoli, Renato Zambello, Shinsuke Iida, Takashi Ikeda, Satoshi Iyama, Morio Matsumoto, Chihiro Shimazaki, Kazutaka Sunami, Kenshi Suzuki, Michihiro Uchiyama, Youngil Koh, Kihyun Kim, Jae Hoon Lee, Chang-Ki Min, Hillary Blacklock, Hugh Goodman, Annette Neylon, David Simpson, Sebastian Grosicki, Artur Jurczyszyn, Adam Walter-Croneck, Krzysztof Warzocha, Luis Araujo, Claudia Moreira, Vadim Doronin, Larisa Mendeleeva, Vladimir Vorobyev, Andrej Vranovsky, Adrian Alegre, Mercedes Gironella, Marta Sonia Gonzalez Perez, Carmen Montes, Enrique Ocio, Paula Rodriguez, Mats Hardling, Birgitta Lauri, Ming-Chung Wang, Su-Peng Yeh, Mutlu Arat, Fatih Demirkan, Zafer Gulbas, Sevgi Kalayoglu Besisik, Ihsan Karadogan, Tulin Tuglular, Ali Unal, Filiz Vural, Jonathan Sive, Matthew Streetly, Kwee Yong, Jason Tache, Attal, Michel, Richardson, Paul G, Rajkumar, S Vincent, San-Miguel, Jesu, Beksac, Meral, Spicka, Ivan, Leleu, Xavier, Schjesvold, Fredrik, Moreau, Philippe, Dimopoulos, Meletios A, Huang, Jeffrey Shang-Yi, Minarik, Jiri, Cavo, Michele, Prince, H Mile, Macé, Sandrine, Corzo, Kathryn P, Campana, Frank, Le-Guennec, Solenn, Dubin, Franck, Anderson, Kenneth C, and ICARIA-MM study group
- Subjects
Male ,medicine.medical_specialty ,Asia ,030204 cardiovascular system & hematology ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Antibodies ,Dexamethasone ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Monoclonal ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Humans ,030212 general & internal medicine ,Progression-free survival ,Aged ,Antibodies, Monoclonal ,Europe ,Female ,Middle Aged ,Multiple Myeloma ,Neoplasm Recurrence, Local ,North America ,Progression-Free Survival ,Thalidomide ,Treatment Outcome ,Multiple myeloma ,Lenalidomide ,Isatuximab ,business.industry ,Bortezomib ,General Medicine ,Pomalidomide ,medicine.disease ,Neoplasm Recurrence ,Local ,business ,Isatuximab, pomalidomide, low-dose dexamethasone ,medicine.drug - 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