# A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)

> **NCT04512235** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Alexion Pharmaceuticals, Inc.** · enrollment: 281 (actual)

## Conditions studied

- AL Amyloidosis

## Interventions

- **DRUG:** CAEL-101
- **OTHER:** Placebo
- **DRUG:** cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen

## Key facts

- **NCT ID:** NCT04512235
- **Lead sponsor:** Alexion Pharmaceuticals, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2020-11-03
- **Primary completion:** 2025-04-08
- **Final completion:** 2027-04-08
- **Target enrollment:** 281 (ACTUAL)
- **Last updated:** 2026-04-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04512235

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04512235, "A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT04512235. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*