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NCT00325416 · ClinicalTrials.gov registry record · Phase 1
Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma.
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 177
- Enrollment target
NCT00325416: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00325416 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 177 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (195% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00325416, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 177 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the safest dose of topotecan when given in a high dose before a stem cell transplant; topotecan will be given with melphalan.
Primary Outcome
MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m\^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (\> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety. Phase I Dose Escalation: Level 1 - 20 mg/
Interventions
- DRUG melphalan
- PROCEDURE Autologous Stem Cell Rescue
- DRUG topotecan (TPT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2001-11-19 |
| Est. Completion | 2018-01-30 |
| Phase | Phase 1 |
What the finished NCT00325416 record still lists
NCT00325416 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (195% higher).
The record links to 0 conditions, and to 3 interventions - of which melphalan is the first listed.
NCT00325416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00325416 about?
NCT00325416 is a clinical study titled "Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma.". The purpose of this research study is to determine the safest dose of topotecan when given in a high dose before a stem cell transplant; topotecan will be given with melphalan.
What is the current status of trial NCT00325416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 177 participants. The study started on 2001-11-19. Estimated completion is 2018-01-30.
What interventions are being tested in trial NCT00325416?
The interventions under investigation include: melphalan (DRUG), Autologous Stem Cell Rescue (PROCEDURE), topotecan (TPT) (DRUG).
Who is sponsoring clinical trial NCT00325416?
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 NCT00325416's enrollment target sits among peer trials
177 313th of 2000 higher than 1,685 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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