NCT04617925

A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis

A Phase 2 Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Stichting European Myeloma Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase 2 study in subjects with previously treated patients with light chain (AL) amyloidosis in need for therapy. Approximately 35 subjects will receive therapy with belantamab mafodotin. Subject participation will include a Screening Phase, a Treatment Phase, a Post-Treatment Observation Phase, and a Long-term Follow-up Phase. A safety run-in will be conducted in 6 subjects treated with belantamab mafodotin for at least 1 cycle. According to the two-stage statistical design of the study, an interim analysis of efficacy will occur. If after 15 patients have been enrolled at least 3 complete or very good partial responses have been recorded, the accrual will continue until all planned patients have been enrolled

Conditions

• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	Belantamab mafodotin	Belantamab mafodotin will be administered as a monotherapy intravenously at a 2.5 mg/kg calculated dose

Timeline

• Start date: 2021-02-26
• Primary completion: 2025-07-17
• Completion: 2025-07-17
• First posted: 2020-11-05
• Last updated: 2025-09-05

Locations

6 sites across 6 countries: France, Germany, Greece, Italy, Netherlands, United Kingdom