Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

Summary

Primary Objective: To evaluate the pharmacokinetics (PK) of isatuximab. Secondary Objectives: * To evaluate the safety and tolerability of isatuximab. * To assess the preliminary antitumor effect of isatuximab. * To evaluate the immunogenicity of isatuximab.

Timeline

Start

2018-10-22

Primary completion

2020-09-06

Completion

2023-08-25

Publications

• Sun M, Jing H, Qu X, Dong F, Li Y, Feng Z, Ziti-Ljajic S, Semiond D, Li L, Qi J, Qiu L. Phase 1 study of isatuximab monotherapy in Chinese patients with relapsed/refractory multiple myeloma. Sci Rep. 2024 Nov 11;14(1):27550. doi: 10.1038/s41598-024-59186-1.

Drugs

Indications