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

Sponsor
Stichting European Myeloma Network
Study ID
NCT04617925
Phase
PHASE2
Status
Completed

Conditions

  • AL Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin will be administered as a monotherapy intravenously at a 2.5 mg/kg calculated dose

Study Details

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

Key Dates

Start date
Feb 26, 2021
Status verified
Sep 2025
Primary completion
Jul 17, 2025
Completion
Jul 17, 2025

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: belantamab mafodotin
    Belantamab mafodotin will be administered as an IV infusion at a dose of 2.5 mg/kg every six weeks until progression of disease, unacceptable toxicity or subsequent therapy, for a maximum of eight doses (approximately 12 months), according to the response adapted modifications

Primary Outcome Measure

response rate [ Time Frame: at 6 months (cycle 4) ]

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