RecruitingPhase 1Phase 2NCT05002816

Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma

Sponsor

Yale University

Enrollment

24 participants

Start Date

Feb 21, 2022

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The purpose of this research study is to determine if two drugs approved for treating multiple myeloma, belantamab mafodotin and elotuzumab, are safe and more effective when used together.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — belantamab mafodotin and elotuzumab — in people with multiple myeloma (a blood cancer) whose disease has come back or stopped responding to at least three previous treatments. **You may be eligible if...** - You are 18 or older with multiple myeloma that has relapsed or is refractory (not responding) after at least 3 prior treatment lines - Your previous treatments included an immunomodulatory drug (like lenalidomide), a proteasome inhibitor (like bortezomib), and an anti-CD38 antibody (like daratumumab) - Your blood counts, liver, and kidney function meet minimum thresholds - Your general health is good enough (ECOG score 0–2) **You may NOT be eligible if...** - You have not tried at least 3 prior lines of treatment - Your organ function is too impaired - You have a serious active infection or other condition making treatment unsafe 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

DRUGElotuzumab

Elotuzumab will be administered via intravenous infusion at an established dose of 10 mg/kg on days 1, 8, 15, 22 every 28 days for cycles 1 and 2, followed by 20mg/kg on day 1 of each cycle thereafter, cycles repeated every 28 days.

DRUGBelantamab mafodotin

Belantamab mafodotin will be administered via IV infusion on day 1 of each 28 day cycle. There will be 3 dose levels for belantamab mafodotin, with the starting dose of 1.9 mg/kg IV at every 4 week interval. Up to 12 subjects will be treated at this dose level. If the initial dose is found to be too toxic, dose of belantamab mafodotin 1.9 mg/kg every 8 weeks will be tested, further dose reduction to 1.4mg/kg every 8 weeks will be administered. Following the dose evaluation, there will be a dose expansion cohort wtih 12 additional subjects. There is no dose escalation planned in this study.