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NCT01621672 · ClinicalTrials.gov registry record · Phase 3
UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma
A Phase 3 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
NCT01621672: Completed Phase 3 study, sponsored by University of Arkansas.
NCT01621672 is a Phase 3 study that has completed, run by University of Arkansas. The registered enrollment target is 42 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621672, a Phase 3 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to determine in a phase II trial, whether further maintenance therapy with Revlimid can extend the duration of progression-free survival and the duration of complete or near complete response compared to no further therapy beyond the TT3 protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years with VTD (2003-33) or VRD (2006-66).
Primary Outcome
Progression was defined as any one or more of the following: * Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or * Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or * If patient had serum M protein \< 1 g/dL, urine M protein \< 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the differe
Interventions
- DRUG Revlimid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT01621672 record still lists
NCT01621672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Revlimid is the first listed.
NCT01621672 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01621672 about?
NCT01621672 is a clinical study titled "UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma". The purpose of this study is to determine in a phase II trial, whether further maintenance therapy with Revlimid can extend the duration of progression-free survival and the duration of complete or near complete response compared to no further therapy beyond the TT3 protocol-prescribed 3 years of ma...
What is the current status of trial NCT01621672?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2010-04. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01621672?
The interventions under investigation include: Revlimid (DRUG).
Who is sponsoring clinical trial NCT01621672?
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 NCT01621672's enrollment target sits among peer trials
42 1877th of 2000 higher than 124 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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