Last updated on January 2019

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


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03194867

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Investigational Site Number 2500005
Paris Cedex 12, France
5.02miles
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Recruitment Status: Open


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