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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Amgen |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00067639 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Pegfilgrastim (Neulasta) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Pegfilgrastim (Neulasta) for Mobilization of Peripheral Blood Progenitor Cells (PBPC) in Patients With Multiple Myeloma |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Serum creatinine < 2.0 mg/dl
Contacts and Locations| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 770030 | |
| Principal Investigator: | Chitra Hosing, MD | U.T. M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | ID03-0164 |
| Study First Received: | August 25, 2003 |
| Last Updated: | May 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00067639 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma PBSC mobilization Pegfilgrastim Neulasta |
|
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |