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 clinical trial is studying a drug called Belantamab mafodotin 1.0 mg/kg (12 weeks), a drug called Belantamab mafodotin 1.4 mg/kg (12 weeks), and others for people with al amyloidosis and amyloidosis. The study is currently recruiting participants at 3 locations.

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

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

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NCT05145816


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