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NCT01311687 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
NCT01311687: Completed Phase 3 study, sponsored by Celgene.
NCT01311687 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 455 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01311687, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
Study Summary
The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.
Primary Outcome
Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease required 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow p
Interventions
- DRUG Dexamethasone
- DRUG pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2011-03-11 |
| Est. Completion | 2017-08-29 |
| Phase | Phase 3 |
What the finished NCT01311687 record still lists
NCT01311687 is an interventional study that assigns participants to a tested intervention. The registered 455 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 (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01311687 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01311687 about?
NCT01311687 is a clinical study titled "A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study". The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.
What is the current status of trial NCT01311687?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2011-03-11. Estimated completion is 2017-08-29.
What interventions are being tested in trial NCT01311687?
The interventions under investigation include: Dexamethasone (DRUG), pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01311687?
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 NCT01311687's enrollment target sits among peer trials
455 829th of 2000 higher than 1,170 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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