Phase 1/2a Study of Belantamab Mafodotin for Relapsed or Refractory AL Amyloidosis
This study is testing a drug called Belantamab Mafodotin for people with AL amyloidosis (a rare disease where abnormal proteins build up in organs) that has come back or not responded to previous treatments. Researchers want to find out if Belantamab Mafodotin is safe and what effects it has, both good and bad. They also want to find the best dose to use. The study will have two parts: the first part will test different doses of the drug, and the second part will use the dose found to be safest and most effective. You may be able to join if you are 18 or older and have AL amyloidosis that has returned or not responded to at least one prior treatment, including a proteasome inhibitor, an alkylator, and an anti-CD38 antibody. The study aims to enroll 37 participants, but the current recruitment status is unclear.
- Study design
- This is an interventional study with two parts, aiming to enroll 37 participants. Part 1 will explore different doses of Belantamab Mafodotin to find a safe and effective level.
- What's involved
- Participants in Part 1 will receive Belantamab Mafodotin intravenously every 8 or 12 weeks. Safety will be monitored for up to 24 weeks from the start of treatment in Part 1, and up to 90 days after completing therapy in Part 2.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored for up to 24 weeks from the start of treatment in Part 1, and up to 90 days after completing therapy in Part 2.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Larry Anderson, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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What this trial measures
- Safety/Tolerability as measured by number of subjects with dose limiting toxicity (Part 1)Up to 24 weeks from Cycle 1 Day 1
Safety/Tolerability is measured by the number of participants treated with different dose level of belantamab mafodotin who experience dose limiting toxicity adverse events (AE) \>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0 for Part 1.
- Safety/Tolerability at the recommended Phase II dose of Belantamab Mafodotin, as measured by number of subjects with dose limiting toxicity (Part 2)Up to 90 days after completing therapy
Safety/Tolerability at the recommended Phase II dose of Belantamab Mafodotin is measured by the number of subjects who experience dose limiting toxicities (\>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0) and cardiac and ocular AEs.