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NCT00153920 · ClinicalTrials.gov registry record · Phase 2
Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT00153920: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00153920 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00153920, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.
Primary Outcome
Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; \<5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of
Interventions
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2003-12 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
What the finished NCT00153920 record still lists
NCT00153920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which bortezomib is the first listed.
NCT00153920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00153920 about?
NCT00153920 is a clinical study titled "Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma". Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with ...
What is the current status of trial NCT00153920?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2003-12. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00153920?
The interventions under investigation include: bortezomib (DRUG).
Who is sponsoring clinical trial NCT00153920?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00153920's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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