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A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis

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Trial Profile

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis

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

Latest Information Update: 21 Jun 2024

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At a glance

  • Drugs Anselamimab (Primary) ; Bortezomib; Cyclophosphamide; Dexamethasone
  • Indications Amyloid light-chain amyloidosis; Amyloidosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms CARES
  • Sponsors Alexion AstraZeneca Rare Disease; Caelum Biosciences
  • Most Recent Events

    • 23 May 2024 According to an AstraZeneca media release, data from the the study will be presented at the 2024 International Symposium on Amyloidosis (ISA).
    • 27 Nov 2023 Outcome measures amended. Time Frame changed from 50 weeks to Up to week 52.
    • 27 Nov 2023 Planned End Date changed from 14 Dec 2024 to 14 Dec 2026.
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