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NCT00307086 · ClinicalTrials.gov registry record · Phase 2
Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
A Phase 2 study of Multiple Myeloma and Plasma Cell Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00307086: Completed Phase 2 study of Multiple Myeloma and Plasma Cell Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00307086 is a Phase 2 study of Multiple Myeloma and Plasma Cell Leukemia that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 30 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00307086, a Phase 2 study of Multiple Myeloma and Plasma Cell Leukemia, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objectives of this study are to: * To determine the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen. * To determine the safety, tolerability, and response rates of bortezomib given in combination with high-dose melphalan, as a conditioning regimen, for tandem transplants in patients with primary refractory multiple myeloma or plasma cell leukemia. The secondary objectives of this study are to: * To determine gene expression profiles (pharmacogenomics) and perform RTPCR for Fanconi anemia pathway genes, prior to and after treatment with bortezomib, in patients with primary refractory multiple myeloma and plasma cell leukemia and correlate profiles with responses to treatment. * To determine the time to disease progression and overall survival in patients with primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib followed by tandem autologous transplantation * To determine the response rates of 2 cycles of bortezomib in patients with primary refractory multiple myeloma or plasma cell leukemia
Primary Outcome
Median overall survival after first peripheral blood stem cell transplant (PBSCT).
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Bortezomib
- PROCEDURE PBSCT
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-06 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT00307086 record still lists
NCT00307086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Melphalan is the first listed.
NCT00307086 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00307086 about?
NCT00307086 is a clinical study titled "Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants". The primary objectives of this study are to: * To determine the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen. * To determine the safety, tolerability, and response rates of bortezomib given in combination with high-dose melphalan, as a...
What is the current status of trial NCT00307086?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2005-06. Estimated completion is 2012-03.
What conditions does trial NCT00307086 study?
This clinical trial studies the following conditions: Multiple Myeloma, Plasma Cell Leukemia.
What interventions are being tested in trial NCT00307086?
The interventions under investigation include: Melphalan (DRUG), Bortezomib (DRUG), PBSCT (PROCEDURE).
Who is sponsoring clinical trial NCT00307086?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00307086 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00307086's enrollment target sits among peer trials
30 338th of 438 higher than 80 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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