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

NCT00067639 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-08-01

No results posted yet for this study

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

Interventions

DRUG

Pegfilgrastim (Neulasta)

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

PROCEDURE

Apheresis

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

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Chitra Hosing, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00067639 on ClinicalTrials.gov