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Mobilization of Stem Cells With AMD3100 in Multiple Myeloma Patients

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Completed

18 to 78

Pharmaceutical / Industry

AMD3100-3102
NCT00103662

Trial Description

Summary

The purpose of this study is to determine whether the combination of AMD3100 and G-CSF (filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.

Further Study Information

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim, a colony stimulating factor, is used to cause the growth of stem cells, which can then be collected from the peripheral blood by a process called apheresis. AMD3100 aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation are correlated to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of AMD3100 with filgrastim is better than filgrastim alone in helping multiple myeloma patients collect more than 6 million stem cells in two or less apheresis sessions.

Eligibility Criteria

Inclusion Criteria:

Diagnosis of multiple myeloma in first or second complete or partial remission

ECOG performance status of 0 or 1

White Blood Cell count (WBC) > 2.5 x 10^9/L

Platelet (PLT) > 100 x 10^9/L

Exclusion Criteria:

Failed previous stem cell collection

Previous stem cell transplantation

Brain metastases or myelomatous meningitis

Radiation to pelvis

History of ventricular arrhythmias

Trial Contact Information

Trial Lead Organizations/Sponsors

Genzyme Corporation

Medical Monitor

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00103662
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.