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NCT00215943 · ClinicalTrials.gov registry record · Phase 3
Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)
A Phase 3 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
NCT00215943: Clinical Trial Phase 3 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00215943 is a Phase 3 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00215943, a Phase 3 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
Study Summary
Investigators planned to accrue 176 participants, to compare the response rate, overall response rate and survival of patients with multiple myeloma (MM) when randomized to two regimens (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone). Investigators also planned to test if treatment with zoledronate immediately prior to chemotherapy results in an enhanced response to treatment (i.e. increase in complete response rates).
Primary Outcome
Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of seru
Interventions
- DRUG dexamethasone
- DRUG vincristine
- DRUG thalidomide
- DRUG zoledronic acid
- DRUG adriamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2003-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
Why NCT00215943 stopped before completion
NCT00215943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which dexamethasone is the first listed.
NCT00215943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00215943 about?
NCT00215943 is a clinical study titled "Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)". Investigators planned to accrue 176 participants, to compare the response rate, overall response rate and survival of patients with multiple myeloma (MM) when randomized to two regimens (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone). Investigators also planned to test if tre...
What is the current status of trial NCT00215943?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2003-06. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00215943?
The interventions under investigation include: dexamethasone (DRUG), vincristine (DRUG), thalidomide (DRUG), zoledronic acid (DRUG), adriamycin (DRUG).
Who is sponsoring clinical trial NCT00215943?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00215943's enrollment target sits among peer trials
90 1724th of 2000 higher than 263 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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