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A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

Trial Profile

A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2024

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At a glance

  • Drugs Daratumumab (Primary) ; Bortezomib; Cyclophosphamide; Cyclophosphamide; Dexamethasone; Dexamethasone; Hyaluronidase
  • Indications Amyloid light-chain amyloidosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ANDROMEDA
  • Sponsors Janssen Pharmaceutical KK; Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 03 Mar 2023 Results of subgroup analysis assessing safety and efficacy of daratumumab plus bortezomib/cyclophosphamide/dexamethasone in Asian patients with newly diagnosed AL amyloidosis, published in the Annals of Hematology.
    • 01 Jun 2022 Results of an analysis assessed the patient-reported outcomes published in the American Journal of Hematology
    • 30 Dec 2021 Planned End Date changed from 2 Aug 2024 to 16 Aug 2024.
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