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Pegfilgrastim (Neulasta) for Stem Cell Mobilization in Patients With Multiple Myeloma
This study has been completed.
First Received: August 25, 2003   Last Updated: May 23, 2007   History of Changes
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 48
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Age 18 years or older.
  • Patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation and PBPC cell collection without chemopriming.
  • Zubrod performance status < 3 (Appendix E)
  • Serum bilirubin < 1.5 times the upper limit of normal. Serum SGOT and SGPT < 2 times the upper limit of normal.

Serum creatinine < 2.0 mg/dl

  • WBC greater > 4,500/ul
  • Platelet count > 100,000/ul prior to first apheresis procedure
  • Patients should not have received prior chemotherapy. Only patients who have been treated with thalidomide+/- dexamethasone will be eligible.
  • Sufficient peripheral venous access or central venous catheter
  • Informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067639

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 770030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Amgen
Investigators
Principal Investigator: Chitra Hosing, MD U.T. M.D. Anderson Cancer Center
  More Information

No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
PBSC mobilization
Pegfilgrastim
Neulasta

Study placed in the following topic categories:
Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 02, 2009