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NCT00395967 · ClinicalTrials.gov registry record · Phase 2
AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00395967 is a Phase 2 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 5 participants.
The verdict
NCT00395967, a Phase 2 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria. The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
Interventions
- DRUG G-CSF plus plerixafor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2005-04 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00395967
The ClinicalTrials.gov registry entry for NCT00395967 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which G-CSF plus plerixafor is the first listed.
NCT00395967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00395967 about?
NCT00395967 is a clinical study titled "AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone". This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were e...
What is the current status of trial NCT00395967?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2005-04. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00395967?
The interventions under investigation include: G-CSF plus plerixafor (DRUG).
Who is sponsoring clinical trial NCT00395967?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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