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NCT00396383 · ClinicalTrials.gov registry record · Phase 2
Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT00396383: Clinical Trial Phase 2 study, sponsored by Genzyme, a Sanofi Company.
NCT00396383 is a Phase 2 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00396383, a Phase 2 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2\*10\^6 CD34+ cells/kg and the target is ≧4\*10\^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of transplant will be assessed for a minimum of one year.
Primary Outcome
Number of participants achieving a target of ≥ 4\*10\^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.
Interventions
- DRUG plerixafor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2004-11 |
| Est. Completion | 2007-05 |
| Phase | Phase 2 |
Why NCT00396383 stopped before completion
NCT00396383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which plerixafor is the first listed.
NCT00396383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00396383 about?
NCT00396383 is a clinical study titled "Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation". This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients....
What is the current status of trial NCT00396383?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2004-11. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00396383?
The interventions under investigation include: plerixafor (DRUG).
Who is sponsoring clinical trial NCT00396383?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00396383's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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