Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

• Status: Active, not recruiting
• Trial end date: 2022-09-30

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pomalidomide; Thalidomide