Clinical trial · no report yet · Phase 3
NCT04504825
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)
- NCT04504825 ↗
- Active, not recruiting
- Alexion Pharmaceuticals, Inc.
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- AL Amyloidosis
- Interventions
- CAEL-101; Placebo; cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen
- Arms
- CAEL-101 combined with SoC plasma cell dyscrasia · Experimental
- Placebo combined with SoC plasma cell dyscrasia · Placebo comparator
- Enrollment
- 125
- Primary outcomes
- A Hierarchical Combination of Time to All-cause Mortality and Frequency of Cardiovascular Hospitalizations (CVHs) Analyzed by Win Ratio
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Start
- Aug 25, 2020
- Primary completion
- May 10, 2025
- Results posted
- Yes
- Registry record
- NCT04504825 · updated Jul 2, 2026
Publications
linked from the registry- Wechalekar AD, Dispenzieri A, Sanchorawala V, Kastritis E, Bhutani D, Bianchi G, Jimenez-Zepeda VH, Suzuki K, Lentzsch S, Huart A, Carpinteiro A, Swenson ES, Khan Z, Catini J, Kulkarni H, Meltzer B, Lake S, Liedtke M; CARES Investigators. Efficacy and Safety of Anselamimab in Immunoglobulin Light Chain Amyloidosis: Results From the Randomized CARES Trials. J Clin Oncol. 2026 Jul 10;44(20):1899-1910. doi: 10.1200/JCO-26-00755. Epub 2026 May 29. PubMed 42212672