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

• Status: Active, not recruiting
• Trial end date: 2022-05-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion criteria:

• Known diagnosis of symptomatic multiple myeloma.

• At least 2 prior lines of therapies which must include treatment with at least 1 of an immunomodulatory drug (IMiD) or a proteasome inhibitor (PI). The patients must have received an IMiD or a PI for ≥2 cycles or ≥2 months of treatment.

• Patients must have been responsive to at least 1 prior line of therapy (minimal response or better).

• Refractory to the most recently received IMiD or PI included therapy (ie, patients must have progressed during or within 60 days of completion of treatment with IMiD or PI). For patients who have received more than 1 type of IMiD or PI, their disease must be refractory to the most recent one.

• Measurable disease defined as at least 1 of the following:

• Serum M-protein ≥0.5 g/dL (≥5 g/L);

• Urine M-protein ≥200 mg/24 hours.

• Written informed consent.

Exclusion criteria:

• <18 years old.

• Eastern Cooperative Oncology Group (ECOG) performance status >2.

• Life expectancy of less than 3 months.

• Pretreated with any anticluster of differentiation (CD) 38 agent.

• Concurrent plasma cell leukemia.

• Known amyloidosis.

• Disease measurable only by serum free light chain (FLC) analysis.

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