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NCT00065351 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
NCT00065351 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 222 participants.
The verdict
NCT00065351, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
Study Summary
For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline. Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter. Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.
Interventions
- DRUG CC-5013
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2003-07-01 |
| Est. Completion | 2007-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00065351
The ClinicalTrials.gov registry entry for NCT00065351 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CC-5013 is the first listed.
NCT00065351 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00065351 about?
NCT00065351 is a clinical study titled "Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma". For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline. Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will ...
What is the current status of trial NCT00065351?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2003-07-01. Estimated completion is 2007-03-01.
What interventions are being tested in trial NCT00065351?
The interventions under investigation include: CC-5013 (DRUG).
Who is sponsoring clinical trial NCT00065351?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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