At a glance
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A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Isatuximab SAR650984 and Cemiplimab REGN2810 for Plasma Cell Myeloma. Completed, enrolled 109 participants across 30 sites in 10 countries.
Detailed Summary
Primary Objectives: * To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma. * To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria. Secondary Objectives: * To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS). * To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination. * To assess the immunogenicity of isatuximab and cemiplimab when given in combination.
Study Details
Timeline
Interventions
Pharmaceutical form: solution for infusion Route of administration: intravenous
Pharmaceutical form: solution for infusion Route of administration: intravenous