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NCT00067639 · ClinicalTrials.gov registry record · Phase 2
Pegfilgrastim (Neulasta) for Stem Cell Mobilization in Patients With Multiple Myeloma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00067639: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00067639 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00067639, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for autologous transplantation. One of the cited advantages of this procedure is the avoidance of bone marrow harvest, which frequently requires general anesthesia. Other advantages include faster neutrophil and platelet engraftment times, faster immune recovery, decrease in the amount of tumor contamination and technical ability to obtain stem cells from patients previously considered unharvestable because of marrow fibrosis or because of prior radiotherapy to the pelvis. Filgrastim has emerged as the preferred cytokine for stem cell mobilization based on its safety profile and the positive experience in granulocyte donors however, the number of circulating CD34+ cells does not occur until the third day after starting filgrastim injections. Pegfilgrastim stimulates the production and maturation of neutrophil precursors and enhances the functions of mature neutrophils in the same manner as filgrastim. Data form normal volunteers and in studies of patients with cancer have shown prolonged serum levels of the cytokine, with "self-regulation" of pegfilgrastim levels as a function of the neutrophil count. This confers a therapeutic advantage in clinical settings by allowing a less frequent dosing.
Interventions
- PROCEDURE Apheresis
- DRUG Pegfilgrastim (Neulasta)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2003-12 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00067639
The ClinicalTrials.gov registry entry for NCT00067639 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Apheresis is the first listed.
NCT00067639 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00067639 about?
NCT00067639 is a clinical study titled "Pegfilgrastim (Neulasta) for Stem Cell Mobilization in Patients With Multiple Myeloma". In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for autologous transplantation. One of the cited advantages of this procedure is the avoidance of bone marrow harvest, which frequently requires general anesthesia. Other advantages include faster neutrophil and...
What is the current status of trial NCT00067639?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2003-12. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00067639?
The interventions under investigation include: Apheresis (PROCEDURE), Pegfilgrastim (Neulasta) (DRUG).
Who is sponsoring clinical trial NCT00067639?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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