NCT05922501

Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma

A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.

Detailed description

This is a phase II study of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. Approximately 50 participants will take part in this research study. The primary objective is determining the overall response rate of the treatment. Treatment is until progression, adverse events, or withdrawal of consent.

Conditions

• Relapsed Cancer
• Refractory Multiple Myeloma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab	An IgG1-derived monoclonal antibody that targets CD38 proteins, administered intravenously.
DRUG	Belantamab mafodotin	An antibody-drug conjugate that is the combination of an antibody targeting BCMA and a drug, administered intravenously.
DRUG	Pomalidomide	An immunomodulatory agent, capsule taken orally.
DRUG	Dexamethasone	A glucocorticoid which is a substance that stops inflammation cause by immune system disorders, tablet taken orally.

Timeline

• Start date: 2024-05-31
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2023-06-28
• Last updated: 2026-01-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study