A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
Public ClinicalTrials.gov record NCT04973137. 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.
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Official title
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
Study identification
- NCT ID
- NCT04973137
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 208 participants
Conditions and interventions
Conditions
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 30, 2021 (Actual)
- Primary completion
- Apr 2, 2025 (Actual)
- Completion
- Jun 20, 2025 (Actual)
- Last update posted
- Dec 16, 2025
2021 – 2025
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale Cancer Center | North Haven | Connecticut | 06473 | — |
| Smilow Cancer Hospital Care Center at Trumbull | Trumbull | Connecticut | 06611 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Johns Hopkins University | Bethesda | Maryland | 20814-1422 | — |
| Boston University School of Med. | Boston | Massachusetts | 02118 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | — |
| Perlmutter Cancer Center - 38th Street | New York | New York | 10016 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| New York University Langone Hospital - Long Island | New York | New York | 11501 | — |
| Duke Clinical Research Institute | Durham | North Carolina | 27705 | — |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | — |
| The Ohio State University College of Medicine | Columbus | Ohio | 43210 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Vanderbilt - Ingram Cancer Center - Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | — |
| University of Washington | Seattle | Washington | 98109 | — |
| Froedtert and Medical College of Wisconsin | 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 88 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04973137, 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 Dec 16, 2025 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04973137 live on ClinicalTrials.gov.