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NCT01660633 · ClinicalTrials.gov registry record · Phase 2
Safety & Efficacy Study High Dose Evomela Injection for MA Conditioning in MM Patients With Autologous Transplantation
A Phase 2 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT01660633: Completed Phase 2 study, sponsored by Acrotech Biopharma.
NCT01660633 is a Phase 2 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01660633, a Phase 2 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this trial is to confirm the safety and efficacy of high-dose Melphalan HCL for Injection (Propylene Glycol-Free) as a myeloablative conditioning regimen in multiple myeloma patients (MM) undergoing autologous transplantation.
Primary Outcome
AE coding will be performed using the MedDRA Version 11.0 or greater. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.0 whenever possible. AEs occurring when treatment starts on Day -3 through Day + 100 will be recorded in the AE section of the eCRF and causality will be assigned by the Principal Investigator.
Interventions
- DRUG High-Dose Melphalan HCL for Injection (Propylene Glycol-Free)
- OTHER Autologous Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01660633 record still lists
NCT01660633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which High-Dose Melphalan HCL for Injection (Propylene Glycol-Free) is the first listed.
NCT01660633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01660633 about?
NCT01660633 is a clinical study titled "Safety & Efficacy Study High Dose Evomela Injection for MA Conditioning in MM Patients With Autologous Transplantation". The purpose of this trial is to confirm the safety and efficacy of high-dose Melphalan HCL for Injection (Propylene Glycol-Free) as a myeloablative conditioning regimen in multiple myeloma patients (MM) undergoing autologous transplantation.
What is the current status of trial NCT01660633?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2012-12. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01660633?
The interventions under investigation include: High-Dose Melphalan HCL for Injection (Propylene Glycol-Free) (DRUG), Autologous Transplantation (OTHER).
Who is sponsoring clinical trial NCT01660633?
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 NCT01660633's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 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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