This phase I/II trial is evaluating a combination of two intravenous drugs (Isatuximab and Cemiplimab) for patients with multiple myeloma that has got worse or not responded to prior treatmentA Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma

Inclusion

• 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).