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A Phase 2, Open-label, Single-arm, Proof-of-concept Study Evaluating the Efficacy and Safety of Belantamab Mafodotin Administered in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain Amyloidosis (ALANIS)

Trial Profile

A Phase 2, Open-label, Single-arm, Proof-of-concept Study Evaluating the Efficacy and Safety of Belantamab Mafodotin Administered in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain Amyloidosis (ALANIS)

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Jan 2026

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At a glance

  • Drugs Belantamab mafodotin (Primary) ; Bortezomib (Primary) ; Cyclophosphamide (Primary) ; Dexamethasone (Primary)
  • Indications Amyloid light-chain amyloidosis
  • Focus Proof of concept; Therapeutic Use
  • Acronyms ALANIS
  • Sponsors GSK

Most Recent Events

  • 16 Dec 2025 Planned End Date changed from 27 Oct 2031 to 4 Feb 2032.
  • 16 Dec 2025 Planned primary completion date changed from 30 Apr 2027 to 10 Aug 2027.
  • 16 Dec 2025 Planned initiation date changed from 1 Dec 2025 to 11 Mar 2026.

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