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

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.

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.