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NCT00507416 · ClinicalTrials.gov registry record · Phase 3
Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 502
- Enrollment target
NCT00507416: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT00507416 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 502 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00507416, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 502 participants
- Enrollment target
Study Summary
This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem cell transplantation.
Primary Outcome
PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria. Progressive disease requires 1 of the following: * Increase of ≥ 25% from nadir in: * Serum M-component (absolute increase ≥ 0.5 g/dl) * Urine M-compo
Interventions
- DRUG Melphalan
- DRUG Dexamethasone
- DRUG Prednisone
- DRUG Bortezomib
- DRUG Thalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2007-06 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT00507416 record still lists
NCT00507416 is an interventional study that assigns participants to a tested intervention. The registered 502 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 (35% lower).
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT00507416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00507416 about?
NCT00507416 is a clinical study titled "Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone". This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered can...
What is the current status of trial NCT00507416?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2007-06. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00507416?
The interventions under investigation include: Melphalan (DRUG), Dexamethasone (DRUG), Prednisone (DRUG), Bortezomib (DRUG), Thalidomide (DRUG).
Who is sponsoring clinical trial NCT00507416?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00507416's enrollment target sits among peer trials
502 743rd of 2000 higher than 1,258 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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