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NCT01570387 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
A Phase 1 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01570387: Completed Phase 1 study, sponsored by Boston Medical Center.
NCT01570387 is a Phase 1 study that has completed, run by Boston Medical Center. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01570387, a Phase 1 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study seeks to enroll patients with AL amyloidosis, for whom treatment with one of the standard melphalan chemotherapy-based regimens is either not recommended or is not their preference. Pomalidomide (CC-4047) is a drug given by mouth, which can change or regulate the functioning of the immune system. So, in theory, it may reduce or prevent the production of the amyloid protein. Pomalidomide is not currently FDA-approved for AL Amyloidosis. Pomalidomide is chemically similar to thalidomide and lenalidomide, both of these drugs have been approved by the FDA for treatment of patients with multiple myeloma (MM), a disease similar to AL Amyloidosis. Participants in this study will receive pomalidomide and dexamethasone. Phase I is a dose-escalation study and dose escalation will proceed through 3 dose-levels according to standard rules in which dose levels are started sequentially after complete evaluation of the occurrence of dose-limiting toxicities. In the Phase II portion, participants will receive pomalidomide and dexamethasone using the defined maximum tolerated dose.
Primary Outcome
Number of patients in Phase I cohort 1 experiencing dose-limiting toxicity at the 2 milligram dose of pomalidomide combined with dexamethasone in subjects with previously- treated light-chain amyloidosis
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2012-06 |
| Est. Completion | 2019-04 |
| Phase | Phase 1 |
What the finished NCT01570387 record still lists
NCT01570387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01570387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01570387 about?
NCT01570387 is a clinical study titled "A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis". This study seeks to enroll patients with AL amyloidosis, for whom treatment with one of the standard melphalan chemotherapy-based regimens is either not recommended or is not their preference. Pomalidomide (CC-4047) is a drug given by mouth, which can change or regulate the functioning of the immun...
What is the current status of trial NCT01570387?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2012-06. Estimated completion is 2019-04.
What interventions are being tested in trial NCT01570387?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01570387?
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 NCT01570387's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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