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

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.

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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society