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

Official Title

Randomized, Open Label, Multicentre 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

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 CR 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.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS)
Secondary Outcome:
  • Overall Response Rate (ORR)
  • Rate of VGPR or better
  • CR rate
  • Rate of CR with MRD (Minimal Residual Disease) negativity
  • Overall Survival (OS)
  • Time to Progression (TTP)
  • Second Progression Free Survival (PFS2)
  • Duration of response (DOR)
  • Number of patients with adverse events according to the National Cancer Institute - Common Toxicity Criteria (NCI- CTC) version 4.03 grading scaling
  • Patient-reported outcome measured with Quality of Life questionnaire
  • Pharmacokinetics of isatuximab
  • Pharmacokinetics of carfilzomib
  • Immunogenicity (ADA)
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.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society