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Pegfilgrastim (Neulasta) for stem cell mobilization



Pegfilgrastim (Neulasta) for stem cell mobilization

For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 48

Location and Contact Information:

MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  770030
United States
Recruiting Chitra  Hosing 713-745-5745


Additional Information:
Study ID Numbers:
  ID03-0164; 
Study Start Date: December 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067639

Other Multiple Myeloma Studies:
1. Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma

2. Bone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy

3. Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma

4. Chemotherapy Related Anemia

5. Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

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Pegfilgrastim (Neulasta) for stem cell mobilization

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