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

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.