A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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