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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion criteria:

• Patients with multiple myeloma previously treated with prior 1 to 3 lines and with measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours).

Exclusion criteria:

• Patients previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.

• Patients with serum free light chain (FLC) measurable disease only.

• Patients less than 18 years old, patients with Eastern Cooperative Oncology Group performance status more than 2.

• Patients with inadequate biological tests.

• Patients with myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.

• Patients with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.

• Patients with known acquired immunodeficiency syndrome related illness (AIDS) or human immunodeficiency virus (HIV) requiring antiretroviral treatment, or hepatitis A, B, or C active infection.

• Women of childbearing potential or male patient with women of childbearing potential who do not agree to use highly effective method of birth control.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.