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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 IIIa AL Amyloidosis

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 IIIa AL Amyloidosis

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

Latest Information Update: 24 Sep 2025

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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

  • 08 Sep 2025 Planned End Date changed from 24 Sep 2027 to 8 Apr 2027.
  • 16 Jul 2025 Primary endpoint (A hierarchical combination of Time to All-cause Mortality and Frequency of Cardiovascular hospitalizations) has not been met, according to an AstraZeneca media release.
  • 16 Jul 2025 According to an AstraZeneca media release, Ashutosh Wechalekar is the Principle investigator of this programme

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