NCT02514668

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

An Open-label, Dose-escalation and Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SAR650984 (Isatuximab) in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Study duration for an individual patient will include a screening period for inclusion of up to 3 weeks, the treatment period and, a follow up period. Treatment with SAR650984 (isatuximab) may continue until disease progression, unacceptable adverse event, or other reason for discontinuation. After study treatment discontinuation, an end of treatment visit will be done at 30 days to assess safety and PK, and at 30 and 60 days for anti-drug antibody (ADA). If the ADA is positive at Day 60, ADA will be repeated every 30 days until ADA is negative. Patients with partial remission or better who discontinue treatment for reasons other than progression of disease will be followed monthly until progression or initiation of subsequent therapy, the final analysis cutoff date, whichever comes first.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab	Pharmaceutical form: solution for infusion Route of administration: intravenous

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-12-02
• Completion: 2021-12-02
• First posted: 2015-08-04
• Last updated: 2022-04-25

Locations

18 sites across 3 countries: United States, Czechia, France