Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Status:
Active, not recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
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.