Project Title

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

Official Title

Phase III, 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.

Project Summary

Primary Objective:

Phase III study 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 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.

The duration of the study for the patients will include a period for screening of up to 3 weeks. Patients will continue study treatment until disease progression, unacceptable adverse reaction, patients' wish or other reason of discontinuation. During follow-up, patients who discontinue the study treatment due to progression of the disease will be followed every 3 months (12 weeks) for further anti-myeloma therapies, progression free survival to the second progression and survival, until death or the cut-off date, whichever comes first. Patients who discontinue the study treatment prior to documentation of disease progression will be followed-up every 4 weeks until confirmation of disease progression, and then every 3 months (12 weeks) for further anti-myeloma therapies, progression free survival to the second progression and survival, until death or the cut-off date, whichever comes first. After progression free survival analysis, patients will be followed yearly for 3 years for survival.

Blood Disorder

  • Multiple Myeloma 

Patient Recruitment Details

Patient recruitment status: Closed

Number of Patients (Globally)

302 participants.