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
Latest Information Update: 24 Sep 2025
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