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Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
Sponsor: Sanofi
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
Conditions
Interventions
Isatuximab
Pharmaceutical form: Concentrated solution for intravenous infusion; Route of administration: Intravenous infusion
Dexamethasone
Pharmaceutical form: Tablet; Route of administration: Oral
Pomalidomide
Pharmaceutical form: Capsule; Route of administration: Oral
Belantamab mafodotin
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Pegenzileukin
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
SAR439459
Pharmaceutical form: Solution for injection; Route of administration: Intravenous
Belumosudil
Pharmaceutical form: tablet; route of administration: oral
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