RecruitingPhase 2NCT05922501

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


Sponsor

Massachusetts General Hospital

Enrollment

50 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a four-drug combination — isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone — for people with multiple myeloma (a blood cancer affecting plasma cells) whose disease has come back or stopped responding to previous treatments. Each of these drugs targets myeloma cells through different mechanisms, and the combination is being tested to see if it can produce deeper and longer-lasting responses. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with multiple myeloma that has relapsed or is no longer responding to treatment - You have received at least one prior line of therapy, including both lenalidomide and a proteasome inhibitor (such as bortezomib or carfilzomib) - Your disease has progressed within 60 days of your last treatment - You have measurable disease detectable by blood, urine, or free light chain tests - Your blood counts and organ function are within acceptable ranges (with some flexibility) **You may NOT be eligible if:** - You have significant organ impairment that makes the treatment unsafe - You are unable to tolerate any of the four drugs in the combination - You do not meet the required blood count minimums at screening 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

An IgG1-derived monoclonal antibody that targets CD38 proteins, administered intravenously.

DRUGBelantamab mafodotin

An antibody-drug conjugate that is the combination of an antibody targeting BCMA and a drug, administered intravenously.

DRUGPomalidomide

An immunomodulatory agent, capsule taken orally.

DRUGDexamethasone

A glucocorticoid which is a substance that stops inflammation cause by immune system disorders, tablet taken orally.


Locations(2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT05922501


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