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NCT00427765 · ClinicalTrials.gov registry record · Phase 2
Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT00427765: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00427765 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00427765, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
Primary Objectives: 1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma. 2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen. 3. To determine the disease-free and overall survival of patients receiving this preparative regimen. 4. To determine the treatment-related morbidity and mortality of this combination of drugs.
Primary Outcome
Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.
Interventions
- DRUG Melphalan
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2004-12 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT00427765 record still lists
NCT00427765 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 2 interventions - of which Melphalan is the first listed.
NCT00427765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00427765 about?
NCT00427765 is a clinical study titled "Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma". Primary Objectives: 1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 d...
What is the current status of trial NCT00427765?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2004-12. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00427765?
The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG).
Who is sponsoring clinical trial NCT00427765?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00427765's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 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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