Pegfilgrastim (Neulasta) for Stem Cell Mobilization in Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Amgen

Criteria

Inclusion Criteria:

1. 1. Age 18 years or older

2. Patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation and PBPC cell collection without chemopriming.

3. Zubrod performance status < 3 (Appendix E)

4. 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

5. WBC > 3,500/ul

6. Platelet count > 100,000/ul prior to first apheresis procedure

7. Patients should not have received prior chemotherapy. Only patients who have been treated with thalidomide, bortezomib, +/- dexamethasone will be eligible.

8. Sufficient peripheral venous access or central venous catheter

9. Informed consent

Exclusion Criteria:

1. Serious intercurrent medical illness

2. History of bleeding disorders (except patients with treated, myeloma related bleeding disorders)

3. Untreated hypercoagulation abnormalities

4. Patients with prior history of pulmonary embolism, deep venous thrombosis requiring anticoagulant therapy, or placement of a venous filter.

5. Untreated symptomatic cardiac disease defined as left ventricular EF of <40% and NYHA functional class of > II (Appendix F)

6. Uncontrolled infection defined as fever or antibiotics within 72 hours of registration.

7. History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.

8. Palpable splenomegaly or craniocaudal spleen length greater than 12 cms

9. Pregnancy

10. Use of aspirin, ibuprofen containing products within 7 days of enrollment

11. History of uncontrolled autoimmune disorder

12. Sickle cell trait/sickle cell disease

13. Women who are lactating or breast feeding

14. 14. Patients with abnormal cytogenetics that may be secondary to myelodysplasia (-5, -7 and 11q23 abnormalities) will be excluded

15. Peripheral vascular disease