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NCT00689936 · ClinicalTrials.gov registry record · Phase 3
Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,623
- Enrollment target
NCT00689936: Completed Phase 3 study, sponsored by Celgene.
NCT00689936 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 1,623 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (110% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00689936, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,623 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
Primary Outcome
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no pro
Interventions
- DRUG Lenalidomide and low-dose dexamethasone
- DRUG Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
- DRUG Melphalan, Prednisone and Thalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,623 participants |
| Start Date | 2008-08-21 |
| Est. Completion | 2016-07-14 |
| Phase | Phase 3 |
What the finished NCT00689936 record still lists
NCT00689936 is an interventional study that assigns participants to a tested intervention. Its 1,623 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (110% higher).
The record links to 0 conditions, and to 3 interventions - of which Lenalidomide and low-dose dexamethasone is the first listed.
NCT00689936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00689936 about?
NCT00689936 is a clinical study titled "Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma". The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
What is the current status of trial NCT00689936?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,623 participants. The study started on 2008-08-21. Estimated completion is 2016-07-14.
What interventions are being tested in trial NCT00689936?
The interventions under investigation include: Lenalidomide and low-dose dexamethasone (DRUG), Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles (DRUG), Melphalan, Prednisone and Thalidomide (DRUG).
Who is sponsoring clinical trial NCT00689936?
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 NCT00689936's enrollment target sits among peer trials
1,623 141st of 2000 higher than 1,860 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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