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NCT01177735 · ClinicalTrials.gov registry record · Phase 2
Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk Multiple Myeloma
A Phase 2 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT01177735: Completed Phase 2 study, sponsored by University of Arkansas.
NCT01177735 is a Phase 2 study that has completed, run by University of Arkansas. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01177735, a Phase 2 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
This is a phase II study, open-label, single institution trial of pomalidomide in GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have included lenalidomide. Patient accrual is 30 over a 2 year period. Primary objective: * To determine progression-free survival (PFS) after initiation of pomalidomide therapy Secondary objective: * To determine the response rate (CR, n-CR, VGPR) and duration of response after pomalidomide therapy. * To determine gene expression profiling (GEP) changes exerted within 48 hours of initiation of daily pomalidomide dosing. * To determine gene expression profiling (GEP) changes exerted within 48 hours of initiation 3 concurrent days of exposure to lenalidomide. * To determine MRI- and PET-CT-defined CR in studies obtained at baseline and every 6 month examinations.
Primary Outcome
Progression -free survival (PFS) after initiation of pomalidomide therapy. Progressive disease is defined as increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL); Urine M-component and/or (the absolute increase must be \> 200 mg/24 h); Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10
Interventions
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01177735 record still lists
NCT01177735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Pomalidomide is the first listed.
NCT01177735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01177735 about?
NCT01177735 is a clinical study titled "Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk Multiple Myeloma". This is a phase II study, open-label, single institution trial of pomalidomide in GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have included lenalidomide. Patient accrual is 30 over a 2 year period. Primary objective: * To determine progression-free survival (PF...
What is the current status of trial NCT01177735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2011-10. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01177735?
The interventions under investigation include: Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01177735?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01177735's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 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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