Dataset from Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines

Primary Objective:

To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in
the prolongation of progression free survival (PFS) using International Myeloma Working Group
(IMWG) as compared to carfilzomib and dexamethasone in participants with relapsed and/or
refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.

Secondary Objectives:

- To evaluate the overall response rate (ORR), rate of very good partial response (VGPR)
or better and complete response (CR) rate in both arms using IMWG criteria.

- To evaluate rate of VGPR or better with minimal residual disease (MRD) negativity in
both arms using IMWG criteria.

- To evaluate the overall survival (OS) in both arms.

- To evaluate safety in both arms.

- To evaluate duration of response (DOR) in both arms.

- To evaluate the time to progression (TTP) in both arms.

- To evaluate the second progression free survival (PFS2) in both arms.

- To evaluate the time to first response.

- To evaluate the time to best response.

- To determine the pharmacokinetic profile of isatuximab in combination with carfilzomib.

- To evaluate the immunogenicity of isatuximab in isatuximab arm.

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