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

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).

Timeline

Start

2015-09-01

Primary completion

2021-12-02

Completion

2021-12-02

Publications

• Mikhael J, Belhadj-Merzoug K, Hulin C, Vincent L, Moreau P, Gasparetto C, Pour L, Spicka I, Vij R, Zonder J, Atanackovic D, Gabrail N, Martin TG, Perrot A, Bensfia S, Weng Q, Brillac C, Semiond D, Mace S, Corzo KP, Leleu X. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab. Blood Cancer J. 2021 May 12;11(5):89. doi: 10.1038/s41408-021-00478-4. No abstract available.

Drugs

Indications