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

NCT02514668 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-04-25

No results posted yet for this study

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).

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

Isatuximab

Pharmaceutical form: solution for infusion Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2021-12-02
Completion
2021-12-02

Countries

  • United States
  • Czechia
  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02514668 on ClinicalTrials.gov