Spots Global Cancer Trial Database for Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

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Trial Identification

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

Official Title: An Open-label, Multi-center Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma

Study ID: NCT03733717

Conditions

Multiple Myeloma

Interventions

Isatuximab SAR650984

Study Description

Brief 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.

Detailed Description: The duration of the study for an individual patient will include a screening period of up to 21 days, a treatment period of repeated 28-day cycles, and a follow-up period. End of treatment visit will be done at 30 (±7) days after last treatment.