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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. 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.
Interventions
- DRUG Melphalan
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2004-12 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00427765
The ClinicalTrials.gov registry entry for NCT00427765 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Melphalan is the first listed.
NCT00427765 reports 0 study locations.
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.
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