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NCT00322491 · ClinicalTrials.gov registry record · Phase 2
Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00322491: Completed Phase 2 study, sponsored by Genzyme, a Sanofi Company.
NCT00322491 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00322491, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.
Primary Outcome
Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Interventions
- DRUG G-CSF Plus Plerixafor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2004-03 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
What the finished NCT00322491 record still lists
NCT00322491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which G-CSF Plus Plerixafor is the first listed.
NCT00322491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00322491 about?
NCT00322491 is a clinical study titled "Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients". This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcome...
What is the current status of trial NCT00322491?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2004-03. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00322491?
The interventions under investigation include: G-CSF Plus Plerixafor (DRUG).
Who is sponsoring clinical trial NCT00322491?
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 NCT00322491's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 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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