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

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00103662

Run by

Genzyme, a Sanofi Company

People needed

302

Starts

2005-01-01

Expected to finish

2008-01-01

Last updated by the study team

2014-03-13

Who can join

Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• City of Hope Samaritan Bone Marrow Transplant Program — Phoenix, Arizona, United States
• Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• City of Hope National Medical Center — Duarte, California, United States
• Cedars-Sinai — Los Angeles, California, United States
• University of California — Los Angeles, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Indiana Blood and Marrow Transplantation Center — Beech Grove, Indiana, United States
• University of Iowa Hosptials and Clinics — Iowa City, Iowa, United States
• Fairview-University Medical Center, University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Kansas City Cancer Center — Kansas City, Missouri, United States
• Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia — St Louis, Missouri, United States
• The Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• St. Vincent's Comprehensive Cancer Center — New York, New York, United States
• New York Hospital — New York, New York, United States
• Memorial Sloan Kettering — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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