Study design and objectives
This was a Phase 1/2 randomized, parallel‐group, open‐label, multicenter study of isatuximab plus cemiplimab in patients with RRMM. Patients were enrolled at 29 sites in 10 countries (Australia, Brazil, Canada, Czech Republic, France, Greece, Hungary, Italy, Spain, and the United States). The study employed an independent Data Monitoring Committee to monitor the safety of patients enrolled in the study. The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice Guidelines, and individual independent ethics committees and institutional review boards approved the study protocol. All patients provided written informed consent prior to the conduct of any study‐related procedures.The study comprised two phases. The primary objective of Phase 1 (safety run‐in) was to confirm the feasibility of isatuximab plus cemiplimab in patients with RRMM and to select the recommended Phase 2 dose (RP2D). The objective of the Phase 2 proof‐of‐concept study was to determine the efficacy of isatuximab plus cemiplimab for patients with RRMM and further evaluate the safety of the combination.