Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial
Evangelos Terpos, MD, PhD
Department of Clinical Therapeutics, Plasma Cell Dyscrasias Unit, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece
The Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA) Study, a multicentre, open-label, randomised phase 3 trial, was published in the June issue of Lancet. This is a phase 3, open-label study compared the efficacy of isatuximab plus carfilzomib-dexamethasone (IsaKd) versus carfilzomib-dexamethasone (Kd) in patients with RRMM. The study was performed at 69 study centres in 16 countries across North America, South America, Europe, and the Asia-Pacific region.
Eligibility criteria included RRMM patients who aged at least 18 years, who had received 1-3 previous lines of therapy and had measurable serum or urine M-protein. Between Nov 15, 2017, and March 21, 2019, 302 patients were randomly assigned (3:2) to IsaKd (n=179) or Kd (n=123). Isatuximab was given at a dose of 10 mg/kg IV weekly for the first 4 weeks and then every 2 weeks. Both groups received the approved schedule of Kd. The primary endpoint was PFS.
Median PFS was not reached in the IsaKd group compared with 19.1 months (95% CI 15.7-not reached) in the Kd group, with a hazard ratio of 0.53 (99% CI 0.32-0.89; one-sided p=0.0007). Treatment-emergent adverse events (TEAEs) of grade 3 or worse occurred in 77% versus 67% of IsaKd and Kd groups, respectively. Fatal TEAEs during study treatment occurred in 6 (3%) patients in both groups.
Professor Philippe Moreau who is the first author of the publication talks to IMS Newsletter for the results of the IKEMA study.
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