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NCT01734928 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 559
- Enrollment target
NCT01734928: Completed Phase 3 study, sponsored by Celgene.
NCT01734928 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 559 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01734928, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 559 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.
Primary Outcome
Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death. Progressive Disease is defined as an Increase of ≥ 25% from nadir in: * Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g * Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 559 participants |
| Start Date | 2013-01-07 |
| Est. Completion | 2022-05-13 |
| Phase | Phase 3 |
What the finished NCT01734928 record still lists
NCT01734928 is an interventional study that assigns participants to a tested intervention. The registered 559 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 (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01734928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01734928 about?
NCT01734928 is a clinical study titled "Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma". The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination o...
What is the current status of trial NCT01734928?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 559 participants. The study started on 2013-01-07. Estimated completion is 2022-05-13.
What interventions are being tested in trial NCT01734928?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT01734928?
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 NCT01734928's enrollment target sits among peer trials
559 673rd of 2000 higher than 1,328 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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