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

Trial Information

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation

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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.

Outcome Description:

Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.

Outcome Time Frame:

up to Day 6

Safety Issue:

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

AMD3100-3102

NCT ID:

NCT00103662

Start Date:

January 2005

Completion Date:

January 2008

Related Keywords:

Multiple Myeloma
Multiple Myeloma
Neoplasms, Plasma Cell

Name	Location
Cleveland Clinic Foundation	Cleveland, Ohio 44195
Roswell Park Cancer Institute	Buffalo, New York 14263
Mayo Clinic	Rochester, Minnesota 55905
Fred Hutchinson Cancer Research Center	Seattle, Washington 98109
H. Lee Moffitt Cancer Center and Research Institute	Tampa, Florida 33612
Loyola University Medical Center	Maywood, Illinois 60153
University of Rochester Medical Center	Rochester, New York 14642
Wilford Hall Medical Center	Lackland Air Force Base, Texas 78236-5300
Rocky Mountain Cancer Center	Denver, Colorado 80218
City of Hope National Medical Center	Los Angeles, California 91010
St. Vincent's Comprehensive Cancer Center	New York, New York 10011
Oregon Health & Science University	Portland, Oregon 97201
Duke University Medical Center	Durham, North Carolina 27710
University of Florida	Gainesville, Florida 32610-0277
Hospital of the University of Pennsylvania	Philadelphia, Pennsylvania 19104
Case Western Reserve University	Cleveland, Ohio 44106
Emory University	Atlanta, Georgia 30322
University of Texas Health Science Center	San Antonio, Texas 78284
Thomas Jefferson University	Philadelphia, Pennsylvania 19107-6541
Ohio State University	Columbus, Ohio 43210
Fairview-University Medical Center, University of Minnesota	Minneapolis, Minnesota 55455
Texas Transplant Institute	San Antonio, Texas 78229
Virginia Commonwealth University	Richmond, Virginia
Yale University School Of Medicine	New Haven, Connecticut 06520
Kansas City Cancer Center	Kansas City, Missouri 64111
The Cancer Center at Hackensack University Medical Center	Hackensack, New Jersey 07601
University of California	San Francisco, California 94108
The University of Texas MD Anderson Cancer Center	Houston, Texas 77030-4009
Memorial Sloan Kettering	New York, New York 10021
City of Hope Samaritan Bone Marrow Transplant Program	Phoenix, Arizona 85006
Indiana Blood and Marrow Transplantation Center	Beech Grove, Indiana 46107
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences	Little Rock, Arkansas 72205
Cedars-Sinai	Los Angeles, California 90048
University of Iowa Hosptials and Clinics	Iowa City, Iowa 52242
Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia	Saint Louis, Missouri 63110
New York Hospital	New York, New York 10032
Utah Blood and Marrow Transplant Program, University of Utah	Salt Lake City, Utah 84132

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