A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)
Public ClinicalTrials.gov record NCT04504825. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT04504825
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Industry
- Enrollment
- 125 participants
Conditions and interventions
Conditions
Interventions
- CAEL-101 Drug
- Placebo Other
- cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 24, 2020
- Primary completion
- May 9, 2025
- Completion
- Oct 21, 2027
- Last update posted
- Mar 16, 2026
2020 – 2027
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | — |
| Research Site | Palo Alto | California | 94304 | — |
| Research Site | San Francisco | California | 94143 | — |
| Research Site | Weston | Florida | 33331 | — |
| Research Site | Indianapolis | Indiana | 46202 | — |
| Research Site | New Orleans | Louisiana | 70112 | — |
| Research Site | Boston | Massachusetts | 02111 | — |
| Research Site | Boston | Massachusetts | 02118 | — |
| Research Site | Boston | Massachusetts | 02215 | — |
| Research Site | Detroit | Michigan | 48201 | — |
| Research Site | Rochester | Minnesota | 55905 | — |
| Research Site | St Louis | Missouri | 63110 | — |
| Research Site | New York | New York | 10032 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Rochester | New York | 14642 | — |
| Research Site | Winston-Salem | North Carolina | 27157 | — |
| Research Site | Cleveland | Ohio | 44195 | — |
| Research Site | Columbus | Ohio | 43210 | — |
| Research Site | Portland | Oregon | 97239 | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Nashville | Tennessee | 37232 | — |
| Research Site | Dallas | Texas | 75390 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Salt Lake City | Utah | 84112 | — |
| Research Site | Seattle | Washington | 98109 | — |
| Research Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04504825, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2026 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04504825 live on ClinicalTrials.gov.