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

NCT04617925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-09-05

No results posted yet for this study

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

Conditions

  • AL Amyloidosis

Interventions

DRUG

Belantamab mafodotin

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Stichting European Myeloma Network

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2025-07-17
Completion
2025-07-17

Countries

  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04617925 on ClinicalTrials.gov