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NCT02841033 · ClinicalTrials.gov registry record · Phase 1
Daratumumab for the Treatment of Patients With AL Amyloidosis
A Phase 1 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02841033: Completed Phase 1 study, sponsored by Boston Medical Center.
NCT02841033 is a Phase 1 study that has completed, run by Boston Medical Center. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02841033, a Phase 1 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.
Primary Outcome
Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio
Interventions
- DRUG daratumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2020-07-17 |
| Phase | Phase 1 |
What the finished NCT02841033 record still lists
NCT02841033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which daratumumab is the first listed.
NCT02841033 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02841033 about?
NCT02841033 is a clinical study titled "Daratumumab for the Treatment of Patients With AL Amyloidosis". Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evalu...
What is the current status of trial NCT02841033?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-03-20. Estimated completion is 2020-07-17.
What interventions are being tested in trial NCT02841033?
The interventions under investigation include: daratumumab (DRUG).
Who is sponsoring clinical trial NCT02841033?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02841033's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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