作者
Philippe Moreau, Meletios-Athanasios Dimopoulos, Joseph Mikhael, Kwee Yong, Marcelo Capra, Thierry Facon, Roman Hajek, Ivan Špička, Ross Baker, Kihyun Kim, Gracia Martinez, Chang-Ki Min, Ludek Pour, Xavier Leleu, Albert Oriol, Youngil Koh, Kenshi Suzuki, Marie-Laure Risse, Gaelle Asset, Sandrine Macé, Thomas Martin, Ivan Spicka, Kim Kihyun, Min Chang-Ki, Koh Youngil, Tom Martin, Hang Quach, Andrew Lim, Helen Crowther, Hanlon Sia, Cyrille Hulin, Mohamad Mohty, Gabor Mikala, Zsolt Nagy, Marta Reinoso Segura, Laura Rosinol, Munci Yagci, Mehmet Turgut, Mamta Garg, Gurdeep Parmar, Brad Augustson, Nelson Castro, Edvan Crusoe, Tomas Pika, Sosana Delimpasi, Kenichi Ishizawa, Anup George, Tatiana Konstantinova, Javier De La Rubia, Kim Sung-Hyun, Angelo Maiolino, Anthony Reiman, Richard LeBlanc, Shigeki Ito, Junji Tanaka, Alexander Luchinin, Irina Kryuchkova, Joaquin Martinez, Jesse Shustik, Lionel Karlin, Anargyros Symeonidis, Miklos Egyed, Mario Petrini, Michele Cavo, Michihiro Uchiyama, Hilary Blacklock, Mutlu Arat, James Griffin, Hannah Hunter, Tonda Buck, Achilles Anagnostopoulos, Konstantinos Konstantopoulos, Tamas Masszi, Sara Bringhen, Barbara Gamberi, Yawara Kawano, Kim Jin Seok, Hakan Ozdogu, Fahir Ozkalemkas
发表日期
2021/6/19
期刊
The Lancet
卷号
397
期号
10292
页码范围
2361-2371
出版商
Elsevier
简介
Background
Isatuximab is an anti-CD38 monoclonal antibody approved in combination with pomalidomide–dexamethasone and carfilzomib–dexamethasone for relapsed or refractory multiple myeloma. This phase 3, open-label study compared the efficacy of isatuximab plus carfilzomib–dexamethasone versus carfilzomib–dexamethasone in patients with relapsed multiple myeloma.
Methods
This was a prospective, randomised, open-label, parallel-group, phase 3 study done at 69 study centres in 16 countries across North America, South America, Europe, and the Asia-Pacific region. Patients with relapsed or refractory multiple myeloma aged at least 18 years who had received one to three previous lines of therapy and had measurable serum or urine M-protein were eligible. Patients were randomly assigned (3:2) to isatuximab plus carfilzomib–dexamethasone (isatuximab group) or carfilzomib–dexamethasone …
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P Moreau, MA Dimopoulos, J Mikhael, K Yong… - The Lancet, 2021