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NCT00113919 · ClinicalTrials.gov registry record · Phase 1
UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients
A Phase 1 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00113919: Clinical Trial Phase 1 study, sponsored by University of Arkansas.
NCT00113919 is a Phase 1 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113919, a Phase 1 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.
Primary Outcome
maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are \> or = 65 years of age or have renal insufficiency, defined as creatinine \> 3g/dL or creatinine clearance \< 30 ml/min
Interventions
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2004-06 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
Why NCT00113919 stopped before completion
NCT00113919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Busulfan is the first listed.
NCT00113919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00113919 about?
NCT00113919 is a clinical study titled "UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients". The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite diffic...
What is the current status of trial NCT00113919?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2004-06. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00113919?
The interventions under investigation include: Busulfan (DRUG).
Who is sponsoring clinical trial NCT00113919?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00113919's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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