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Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

NCT04643002 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-03-30

No results posted yet for this study

Summary

The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.

Conditions

  • Plasma Cell Myeloma Refractory

Interventions

DRUG

Isatuximab

Pharmaceutical form: Concentrated solution for intravenous infusion; Route of administration: Intravenous infusion

DRUG

Dexamethasone

Pharmaceutical form: Tablet; Route of administration: Oral

DRUG

Pomalidomide

Pharmaceutical form: Capsule; Route of administration: Oral

DRUG

Belantamab mafodotin

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

DRUG

Pegenzileukin

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

DRUG

SAR439459

Pharmaceutical form: Solution for injection; Route of administration: Intravenous

DRUG

Belumosudil

Pharmaceutical form: tablet; route of administration: oral

DRUG

Evorpacept

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2027-09-13
Completion
2028-04-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Norway
  • Portugal
  • Puerto Rico
  • South Korea

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 NCT04643002 on ClinicalTrials.gov