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Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

NCT03275285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2026-02-09

Study results available
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Summary

The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

isatuximab SAR650984

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

carfilzomib

Pharmaceutical form: solution for infusion Route of administration: intravenous

DRUG

dexamethasone

Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2022-01-14
Completion
2025-01-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Czechia
  • France
  • Greece
  • Hungary
  • Italy
  • Japan
  • New Zealand
  • Russia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03275285 on ClinicalTrials.gov