Overview

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma

Status:
Active, not recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
Primary Objective: - Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). - Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab. Secondary Objectives: - Part A: - To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM. - Part B: - To evaluate the safety of SAR650984 (isatuximab). - To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS). - To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline. - To evaluate the immunogenicity of SAR650984 (isatuximab).
Phase:
Phase 1
Details
Lead Sponsor:
Sanofi