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NCT04304144 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT04304144: Completed Phase 2 study, sponsored by Alexion Pharmaceuticals.
NCT04304144 is a Phase 2 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04304144, a Phase 2 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
AL 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 the recommended dose of CAEL-101 to facilitate progression of further clinical trials and evaluate safety and tolerability of CAEL-101 in combination with the standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy and daratumumab .
Primary Outcome
An adverse event (AE) was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birt
Interventions
- DRUG Daratumumab
- DRUG CAEL-101
- DRUG SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-03-18 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 2 |
What the finished NCT04304144 record still lists
NCT04304144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Daratumumab is the first listed.
NCT04304144 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04304144 about?
NCT04304144 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis". AL 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 sys...
What is the current status of trial NCT04304144?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-03-18. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT04304144?
The interventions under investigation include: Daratumumab (DRUG), CAEL-101 (DRUG), SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) (DRUG).
Who is sponsoring clinical trial NCT04304144?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04304144's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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