Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

Last updated: February 10, 2014
Sponsor: Genzyme, a Sanofi Company
Overall Status: Completed

Phase

3

Condition

Bone Neoplasm

Cancer/tumors

Leukemia

Treatment

N/A

Clinical Study ID

NCT00103662
AMD3100-3102
2005-003599-39
  • Ages 18-78
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)

  • Recovered from all acute toxic effects of prior chemotherapy

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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

  • Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L

  • Platelet (PLT) > 100*10^9/L

  • Serum creatinine <=2.2 mg/dL

  • Cardiac and pulmonary status sufficient to undergo apheresis and transplantation

  • Negative for HIV

Exclusion Criteria):

  • Failed previous stem cell collection

  • Previous stem cell transplantation

  • Brain metastases or myelomatous meningitis

  • Radiation to ≥ 50% of the pelvis

  • Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality

  • Received bone-seeking radionuclides (e.g. holmium)

  • A residual acute medical condition resulting from prior chemotherapy

Study Design

Total Participants: 302
Study Start date:
January 01, 2005
Estimated Completion Date:
January 31, 2008

Study Description

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor 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 correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Connect with a study center

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Universitätsklinikum Heidelberg,

    Heidelberg, 69120
    Germany

    Site Not Available

  • City of Hope Samaritan Bone Marrow Transplant Program

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Cedars-Sinai

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California

    Los Angeles, California 90095
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32611
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Indiana Blood and Marrow Transplantation Center

    Beech Grove, Indiana 46107
    United States

    Site Not Available

  • University of Iowa Hosptials and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Fairview-University Medical Center, University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Kansas City Cancer Center

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Memorial Sloan Kettering

    New York, New York 10065
    United States

    Site Not Available

  • New York Hospital

    New York, New York 10032
    United States

    Site Not Available

  • St. Vincent's Comprehensive Cancer Center

    New York, New York 10011
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Case Western Reserve University

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Wilford Hall Medical Center

    Lackland AFB, Texas 78236
    United States

    Site Not Available

  • Texas Transplant Institute

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Utah Blood and Marrow Transplant Program, University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Site Not Available

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