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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 is a Phase 2 study that has completed, run by University of Arkansas. The registered enrollment target is 71 participants.
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.
Interventions
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01177735
The ClinicalTrials.gov registry entry for NCT01177735 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pomalidomide is the first listed.
NCT01177735 reports 0 study locations.
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.
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