RecruitingPhase 1Phase 2NCT04643002

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

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

Sponsor

Sanofi

Enrollment

258 participants

Start Date

Jan 25, 2021

Study Type

INTERVENTIONAL

Conditions

Plasma Cell Myeloma Refractory

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This master protocol study is testing isatuximab (a drug that targets a protein called CD38 on myeloma cells) in combination with various other new treatments for patients with relapsed or refractory multiple myeloma — a blood cancer of plasma cells — whose disease has returned after prior therapies. **You may be eligible if...** - You are 18 or older - You have multiple myeloma that has relapsed or stopped responding to treatment - You have received at least 2 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) - Your myeloma is measurable by blood, urine, or other lab tests - Your general health score is 0–1 (ECOG) **You may NOT be eligible if...** - Your organ function is significantly impaired - You are pregnant or breastfeeding - You are refractory to anti-CD38 therapy (certain sub-studies) - You have had certain recent prior treatments that conflict with the sub-study you are eligible for Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsatuximab

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

DRUGDexamethasone

Pharmaceutical form: Tablet; Route of administration: Oral

DRUGPomalidomide

Pharmaceutical form: Capsule; Route of administration: Oral

DRUGBelantamab mafodotin

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

DRUGPegenzileukin

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

DRUGSAR439459

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

DRUGBelumosudil

Pharmaceutical form: tablet; route of administration: oral

DRUGEvorpacept

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

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