Dataset from A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

Primary Objective:

To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose
dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to
pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and
refractory multiple myeloma (MM).

Secondary Objectives:

- To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group
(IMWG) criteria in each arm.

- To compare the Overall Survival (OS) between the two arms.

- To evaluate the Time To Progression (TTP) in each arm.

- To evaluate the PFS in high risk cytogenetic population in each arm.

- To evaluate the Duration of Response (DOR) in each arm.

- To evaluate the safety in both treatment arms.

- To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.

- To evaluate the immunogenicity of isatuximab.

- To assess disease-specific and generic health-related quality of life (HRQL), disease
and treatment-related symptoms, health state utility, and health status.