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A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis — EMN27  

AL Amyloidosis Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04617925
Study type Interventional
Source European Myeloma Network
Contact Efstathios European Myeloma Network (EMN), MD
Phone +31107033123
Email sarah.lonergan@emn.life
Status Recruiting
Phase Phase 2
Start date February 26, 2021
Completion date May 2025
View Details
See also
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