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

NCT00067639 | Completed Phase 2

• 1 other identifier: ID03-0164
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; PBSC mobilization; Pegfilgrastim; Neulasta; PEG-G-CSF

Outcome Measures

Primary Outcomes (1)

• Efficacy of pegfilgrastim in mobilizing progenitor cells

  Baseline to 10 days after pegfilgrastim injection

Study Arms (1)

Pegfilgrastim + Apheresis

EXPERIMENTAL

12 mg Pegfilgrastim as subcutaneous injection on day 1 + Apheresis daily till target stem cell dose reached.

Drug: Pegfilgrastim (Neulasta); Procedure: Apheresis

Interventions

Pegfilgrastim (Neulasta) DRUG

12 mg single injection of pegfilgrastim under the skin prior to apheresis.

Also known as: PEG-G-CSF

Pegfilgrastim + Apheresis

Apheresis PROCEDURE

Collection of stem cells, repeated daily until target stem cell dose reached, maximum of 5 procedures.

Also known as: Leukapheresis

Pegfilgrastim + Apheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 \> 3,500/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, bortezomib, +/- dexamethasone will be eligible.
• Sufficient peripheral venous access or central venous catheter
• Informed consent

You may not qualify if:

• Serious intercurrent medical illness
• History of bleeding disorders (except patients with treated, myeloma related bleeding disorders)
• Untreated hypercoagulation abnormalities
• Patients with prior history of pulmonary embolism, deep venous thrombosis requiring anticoagulant therapy, or placement of a venous filter.
• Untreated symptomatic cardiac disease defined as left ventricular EF of \<40% and NYHA functional class of \> II (Appendix F)
• Uncontrolled infection defined as fever or antibiotics within 72 hours of registration.
• History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.
• Palpable splenomegaly or craniocaudal spleen length greater than 12 cms
• Pregnancy
• Use of aspirin, ibuprofen containing products within 7 days of enrollment
• History of uncontrolled autoimmune disorder
• Sickle cell trait/sickle cell disease
• Women who are lactating or breast feeding
• \. Patients with abnormal cytogenetics that may be secondary to myelodysplasia (-5, -7 and 11q23 abnormalities) will be excluded
• Peripheral vascular disease

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Amgen: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 770030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pegfilgrastim; pegylated granulocyte colony-stimulating factor, human; Blood Component Removal; Leukapheresis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Cytapheresis; Biological Therapy; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Chitra Hosing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2003
• First Posted: August 26, 2003
• Study Start: December 1, 2003
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)