NCT02990338: Phase 3 - Isatuximab, Pomalidomide & Dex VS Pom & Dex in relapsed Myeloma (ICARIA-MM)

ICARIA

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIA-MM)

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIA-MM)

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.