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

Overview

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.

SparkCures ID 973
Trial Phase Phase 1/2
Enrollment 105 Patients
Treatments
Trial Sponsors
  • Sanofi
NCT Identifier

NCT03194867

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion criteria:

  • Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:
    • Serum M-protein ≥ 1 g/dL (≥ 0.5 g/dL in case of immunoglobulin A [IgA] disease), AND/OR
    • Urine M-protein ≥ 200 mg/24 hours, OR
    • In the absence of measurable M-protein, serum immunoglobulin free light chain ≥ 10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (< 0.26 or > 1.65).
  • Patients must have received prior treatment with an immunomodulatory drug (IMiD) (for ≥ 2 cycles or ≥ 2 months of treatment) and a proteasome inhibitor (PI) (for ≥ 2 cycles or ≥ 2 months of treatment).
  • Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line).
  • Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).

Exclusion criteria:

  • Prior exposure to isatuximab or participated clinical studies with isatuximab.
  • Prior exposure to any agent (approved or investigational) that blocks the programmed cell death-1 (PD-1)/PD-L1 pathway.
  • Evidence of other immune related disease/conditions.
  • History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
  • Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
  • Has allogenic haemopoietic stem cell (HSC) transplant.
  • Prior treatment with idelalisib (a PI3K inhibitor).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2.
  • Poor bone marrow reserve.
  • Poor organ function.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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