Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Official Title

A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma


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.

Trial Description

Primary Outcome:

  • Dose Limiting Toxicities (DLTs)
  • Adverse events (AEs) and changes in laboratory tests and vital signs
  • Overall Response Rate (ORR)
Secondary Outcome:
  • Clinical Benefit Rate (CBR)
  • Duration of Response (DOR)
  • Time to Response (TTR)
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Assessment of PK parameter: partial AUC
  • Assessment of PK parameter: Cmax
  • Antibodies to isatuximab
  • Antibodies to cemiplimab
The duration of the study for a patient will include a period for screening of up to 21 days and 3-month post treatment follow up. The cycle duration is 28 days. Patients will continue treatment until disease progression, unacceptable adverse events, consent withdrawal, or any other reason.

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