A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis (EMN27)
A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis (EMN27)
ClinicalTrials.gov ID: NCT04617925
Sponsor: European Myeloma Network
Information provided by: European Myeloma Network (Responsible Party)
Last Update Posted: 2023-03-14
Brief 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.
OFFICIAL TITLE
A Phase 2 Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis
INTERVENTION / TREATMENT
Drug: Belantamab mafodotin
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-02-26 |
| Primary Completion (Estimated) | 2025-05 |
| Study Completion (Estimated) | 2025-05 |
| Enrollment (Estimated) | 35 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
EMN27
|