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RECRUITING
NCT04643002
PHASE1/PHASE2

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: Phase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

258

Start Date

2021-01-25

Completion Date

2028-04-20

Last Updated

2026-03-30

Healthy Volunteers

No

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

Locations (28)

Winship Cancer Institute of Emory University- Site Number : 8400010

Atlanta, Georgia, United States

University of Illinois-Chicago - College of Medicine- Site Number : 8400007

Chicago, Illinois, United States

University of Michigan Health System - Ann Arbor- Site Number : 8400004

Ann Arbor, Michigan, United States

Roswell Park Cancer Institute- Site Number : 8400008

Buffalo, New York, United States

The Ohio State University- Site Number : 8400012

Columbus, Ohio, United States

Investigational Site Number : 0360006

Wollongong, New South Wales, Australia

Investigational Site Number : 0360002

Melbourne, Victoria, Australia

Investigational Site Number : 0360001

Richmond, Victoria, Australia

Investigational Site Number : 2500003

Paris, Washington, France

Investigational Site Number : 2500002

Lille, France

Investigational Site Number : 2500001

Nantes, France

Investigational Site Number : 2500004

Paris, France

Investigational Site Number : 2760006

Frankfurt, Germany

Investigational Site Number : 2760008

Lübeck, Germany

Investigational Site Number : 3000002

Athens, Greece

Investigational Site Number : 3000001

Athens, Greece

Investigational Site Number : 3760002

Jerusalem, Israel

Investigational Site Number : 3760003

Ramat Gan, Israel

Investigational Site Number : 3760001

Tel Aviv, Israel

Investigational Site Number : 3800001

Meldola, Reggio Emilia, Italy

Investigational Site Number : 5780001

Oslo, Norway

Investigational Site Number : 6200001

Coimbra, Portugal

Investigational Site Number : 6200002

Porto, Portugal

Puerto Rico Medical Research Center- Site Number : 8400005

Hato Rey, Puerto Rico, Puerto Rico

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea