RecruitingPhase 1NCT05055063

A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma

A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma (BELLA)

Sponsor

M.D. Anderson Cancer Center

Enrollment

30 participants

Start Date

May 18, 2022

Study Type

INTERVENTIONAL

Conditions

Myeloma

Summary

This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficacy will be assessed through the overall response rate (ORR) at the end of the study. With the limited number of patients for the dose-expansion part, we will not have formal futility monitoring rule.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests belantamab mafodotin — an antibody-drug treatment that targets a specific protein on myeloma cells — for people with high-risk smoldering multiple myeloma (SMM). SMM is a precancerous condition that can develop into active multiple myeloma, and this trial aims to treat it early before it progresses. **You may be eligible if...** - You have been diagnosed with high-risk smoldering multiple myeloma confirmed by bone marrow biopsy (≥10% plasma cells), blood tests showing immune suppression, and flow cytometry showing ≥95% abnormal plasma cells - You are 18 or older with good kidney function and adequate blood counts - You are in good overall health (ECOG 0–2) **You may NOT be eligible if...** - You have already progressed to active multiple myeloma - You have eye conditions that might be worsened by this drug (which can affect vision) - Your kidney function, blood counts, or liver function are too low - You are pregnant or breastfeeding 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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