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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: Completed Phase 2 study, sponsored by Celgene.

NCT00065351 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 222 participants
Start Date 2003-07-01
Est. Completion 2007-03-01
Phase Phase 2
Celgene

308 total trials

What the finished NCT00065351 record still lists

NCT00065351 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher).

The record links to 0 conditions, and to 1 intervention - of which CC-5013 is the first listed.

NCT00065351 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00065351's enrollment target sits among peer trials

222 274th of 2000 higher than 1,726 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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Source: ClinicalTrials.gov NCT00065351, the US trial registry maintained by the National Library of Medicine. NCT00065351 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.