Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis (NCT05145816)
A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Vanderbilt Ingram Cancer Center — Nashville, Tennessee
Age range: 18 Years
🧪 Interventions in This Study
- Belantamab mafodotin 2.5 mg/kg (8 weeks) (DRUG)
- Belantamab mafodotin 1.9 mg/kg (8 weeks) (DRUG)
- Belantamab mafodotin 1.4 mg/kg (12 weeks) (DRUG)
- Belantamab mafodotin 1.9 mg/kg (12 weeks) (DRUG)
- Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages (DRUG)
- Belantamab mafodotin 1.0 mg/kg (12 weeks) (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Vanderbilt Ingram Cancer Center — Nashville, Tennessee
- UT Southwestern Medical Center — Dallas, Texas
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (214) 648-7097
Email: Donglan.Xia@UTSouthwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in AL Amyloidosis
- Ixazomib Maintenance Study in Patients With AL Amyloidosis — Boston, Massachusetts
- Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis — Boston, Massachusetts
- Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis — Orange, California
- A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES) — Duarte, California
- A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES) — Scottsdale, Arizona
- A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement — Palo Alto, California
Explore by condition: All AL Amyloidosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.