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NCT00056160 · ClinicalTrials.gov registry record · Phase 3
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
NCT00056160: Completed Phase 3 study, sponsored by Celgene.
NCT00056160 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 353 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00056160, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
Study Summary
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
Primary Outcome
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
Interventions
- DRUG Dexamethasone
- DRUG CC-5013
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2003-01-01 |
| Est. Completion | 2008-10-01 |
| Phase | Phase 3 |
What the finished NCT00056160 record still lists
NCT00056160 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT00056160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00056160 about?
NCT00056160 is a clinical study titled "CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma". Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
What is the current status of trial NCT00056160?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2003-01-01. Estimated completion is 2008-10-01.
What interventions are being tested in trial NCT00056160?
The interventions under investigation include: Dexamethasone (DRUG), CC-5013 (DRUG).
Who is sponsoring clinical trial NCT00056160?
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 NCT00056160's enrollment target sits among peer trials
353 1028th of 2000 higher than 971 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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