Pegfilgrastim (Neulasta) for Stem Cell Mobilization in Patients With Multiple Myeloma
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Pegfilgrastim (Neulasta) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Chitra Hosing, MD, Principal Investigator, Affiliation: U.T. M.D. Anderson Cancer Center
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.
Clinical Details
Official title: Pegfilgrastim (Neulasta) for Mobilization of Peripheral Blood Progenitor Cells (PBPC) in Patients With Multiple Myeloma
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
MD Anderson Cancer Center, Houston, Texas 770030, United States
Additional Information
Starting date: December 2003
Last updated: May 23, 2007
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