A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)
Public ClinicalTrials.gov record NCT04512235. 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 IIIa AL Amyloidosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIa AL amyloidosis.
Study identification
- NCT ID
- NCT04512235
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 281 participants
Conditions and interventions
Conditions
Interventions
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
- Nov 3, 2020 (Actual)
- Primary completion
- Apr 8, 2025 (Actual)
- Completion
- Apr 8, 2027 (Estimated)
- Last update posted
- Jun 17, 2026
2020 – 2027
United States locations
- U.S. sites
- 32
- U.S. states
- 20
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | 85259 | — |
| Research Site | Duarte | California | 91010 | — |
| Research Site | Palo Alto | California | 94304 | — |
| Research Site | San Francisco | California | 94143 | — |
| Research Site | Jacksonville | Florida | 32224 | — |
| Research Site | Weston | Florida | 33331 | — |
| Research Site | Indianapolis | Indiana | 46202 | — |
| Research Site | New Orleans | Louisiana | 70112 | — |
| Research Site | Baltimore | Maryland | 21201 | — |
| 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 | Chapel Hill | North Carolina | 27599 | — |
| Research Site | Durham | North Carolina | 27705 | — |
| 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 | Madison | Wisconsin | 53792 | — |
| 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 78 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04512235, 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 Jun 17, 2026 · Synced Oct 25, 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 public registry record, listed eligibility criteria, and available contact information for NCT04512235 live on ClinicalTrials.gov.