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
18 Years
78 Years
Both
Multiple Myeloma
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:
No
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 |
