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
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be 18 years of age inclusive or older. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction regimen with autologous stem cell transplant followed by maintenance is considered one line). * RRMM with measurable disease: * Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or * Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/o…
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
- Drug
Locations (28)
- Winship Cancer Institute of Emory University- Site Number : 8400010Atlanta, Georgia
- University of Illinois-Chicago - College of Medicine- Site Number : 8400007Chicago, Illinois
- University of Michigan Health System - Ann Arbor- Site Number : 8400004Ann Arbor, Michigan
- Roswell Park Cancer Institute- Site Number : 8400008Buffalo, New York
- The Ohio State University- Site Number : 8400012Columbus, Ohio
- Investigational Site Number : 0360006Wollongong, New South Wales