Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): A multicentre, open-label, randomised phase 3 trial
The Lancet Jun 23, 2021
Moreau P, Dimopoulos MA, Mikhael J, et al. - Among patients with relapsed multiple myeloma who were enrolled in this prospective, randomised, open-label, parallel-group, phase 3 study, a comparison was made between isatuximab (an anti-CD38 monoclonal antibody) plus carfilzomib–dexamethasone vs carfilzomib–dexamethasone, in terms of efficacy. This investigation was run in 16 countries across North America, South America, Europe, and the Asia-Pacific region. Participants were relapsed or refractory multiple myeloma patients aged at least 18 years who had undergone one to three previous lines of therapy and had measurable serum or urine M-protein. These patients were randomized (3:2) to isatuximab plus carfilzomib–dexamethasone (isatuximab group) or carfilzomib–dexamethasone (control group). Findings revealed that a significant improvement in progression-free survival and depth of response was conferred by isatuximab plus carfilzomib–dexamethasone therapy in patients suffering from relapsed multiple myeloma, affording a new standard of care for this patient populace.
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