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NCT00463385 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
NCT00463385: Completed Phase 2 study, sponsored by Celgene.
NCT00463385 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00463385, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety of and to select a treatment regimen of pomalidomide (CC-4047) either as single-agent or in combination with prednisone to study further in patients with myelofibrosis with myeloid metaplasia (MMM).
Primary Outcome
A clinical responder was defined as either: 1. A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or 2. A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or 3. A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at bas
Interventions
- DRUG Prednisone
- DRUG Pomalidomide
- DRUG Placebo to pomalidomide
- DRUG Placebo to prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2007-04-01 |
| Est. Completion | 2013-12-31 |
| Phase | Phase 2 |
What the finished NCT00463385 record still lists
NCT00463385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT00463385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00463385 about?
NCT00463385 is a clinical study titled "A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia". The purpose of this study is to determine the safety of and to select a treatment regimen of pomalidomide (CC-4047) either as single-agent or in combination with prednisone to study further in patients with myelofibrosis with myeloid metaplasia (MMM).
What is the current status of trial NCT00463385?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2007-04-01. Estimated completion is 2013-12-31.
What interventions are being tested in trial NCT00463385?
The interventions under investigation include: Prednisone (DRUG), Pomalidomide (DRUG), Placebo to pomalidomide (DRUG), Placebo to prednisone (DRUG).
Who is sponsoring clinical trial NCT00463385?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00463385's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 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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