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NCT00925782 · ClinicalTrials.gov registry record · Phase 2
PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation
A Phase 2 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00925782: Completed Phase 2 study, sponsored by Acrotech Biopharma.
NCT00925782 is a Phase 2 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00925782, a Phase 2 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT).
Primary Outcome
AUC (0-t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations. The AUC results provided is the summary of Melphalan PK following
Interventions
- DRUG Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection
- DRUG Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT00925782 record still lists
NCT00925782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection is the first listed.
NCT00925782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00925782 about?
NCT00925782 is a clinical study titled "PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation". To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT).
What is the current status of trial NCT00925782?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00925782?
The interventions under investigation include: Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection (DRUG), Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free) (DRUG).
Who is sponsoring clinical trial NCT00925782?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00925782's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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