NCT04643002

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, Investigator decision, or study termination by the Sponsor i.e., up to Aapproximately 28 months.

Conditions

• Plasma Cell Myeloma Refractory

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-25
• Primary completion: 2027-09-13
• Completion: 2028-04-20
• First posted: 2020-11-24
• Last updated: 2026-03-30

Locations

28 sites across 11 countries: United States, Australia, France, Germany, Greece, Israel, Italy, Norway, Portugal, Puerto Rico, South Korea

Regulatory

• FDA-regulated drug study