RecruitingPhase 1Phase 2NCT05145816

Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis

A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis


Sponsor

University of Texas Southwestern Medical Center

Enrollment

37 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug. The study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2a study is testing belantamab mafodotin — an antibody-drug conjugate (a targeted drug that delivers chemotherapy directly to cancer cells) — in people with AL amyloidosis, a rare disease where abnormal proteins (light chains) are deposited in organs such as the heart, kidneys, and liver, causing damage. The drug targets a protein called BCMA found on the abnormal plasma cells that produce these light chains. The study is for people whose disease has come back or stopped responding to prior treatments. You may be eligible if: - You are 18 years of age or older - You have relapsed or refractory AL amyloidosis confirmed by biopsy - You have measurable disease based on blood or urine tests - You have had at least one prior treatment including a proteasome inhibitor, alkylator, and anti-CD38 antibody (or are not eligible for these) - Your heart function (LVEF) is above 35% and NYHA Class 1–3a - You have adequate blood counts, kidney, and liver function - Your ECOG performance status is 0, 1, or 2 You may NOT be eligible if: - You have previously been treated for active multiple myeloma - You have corneal disease (other than mild punctate keratopathy) - You are eligible for autologous stem cell transplantation - You have significant cardiovascular disease (NYHA Class 3b or 4) - You wear contact lenses (participants must not use contact lenses during the study) - You are pregnant or breastfeeding - You have had recent major surgery (within 4 weeks) - You have active infection requiring treatment 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBelantamab mafodotin 2.5 mg/kg (8 weeks)

2.5 mg/kg IV Belantamab mafodotin IV every 8 weeks for Part 1

DRUGBelantamab mafodotin 1.9 mg/kg (8 weeks)

1.9 mg/kg IV Belantamab mafodotin IV every 8weeks for Part 1

DRUGBelantamab mafodotin 1.4 mg/kg (12 weeks)

1.4 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1

DRUGBelantamab mafodotin 1.9 mg/kg (12 weeks)

1.9 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1

DRUGBelantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages

Belantamab mafodotin Dose 1.0 mg/kg, 1.4 mg/kg, 1.9mg/kg or 2.5mg/kg every 8 weeks or 12 weeks as determined by Part 1 recommended dosages.

DRUGBelantamab mafodotin 1.0 mg/kg (12 weeks)

1.0 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1


Locations(3)

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05145816


Related Trials