Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

• Status: Active, not recruiting
• Trial end date: 2023-02-07

Summary

Primary Objective:

To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients 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 International Myeloma Working Group (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.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate