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NCT00064038 · ClinicalTrials.gov registry record · Phase 3
S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 198
- Enrollment target
NCT00064038: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT00064038 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 198 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00064038, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 198 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I, stage II, or stage III multiple myeloma.
Primary Outcome
Progression is defined as a \> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc. In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 5
Interventions
- OTHER placebo
- DRUG dexamethasone
- DRUG lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2004-11 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00064038 record still lists
NCT00064038 is an interventional study that assigns participants to a tested intervention. The registered 198 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 (74% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00064038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00064038 about?
NCT00064038 is a clinical study titled "S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma". RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or...
What is the current status of trial NCT00064038?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 198 participants. The study started on 2004-11. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00064038?
The interventions under investigation include: placebo (OTHER), dexamethasone (DRUG), lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00064038?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00064038's enrollment target sits among peer trials
198 1389th of 2000 higher than 611 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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