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

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

Timeline

Start

2021-02-26

Primary completion

2025-07-17

Completion

2025-07-17

Drugs

Indications