298
Participants
Start Date
January 31, 2005
Primary Completion Date
July 31, 2006
Study Completion Date
December 31, 2007
Granulocyte colony-stimulating factor plus plerixafor
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Granulocyte colony-stimulating factor plus placebo
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Roswell Park Cancer Institute, Buffalo
University of Rochester Medical Center, Rochester
Hospital of the University of Pennsylvania, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
Virginia Commonwealth University, Richmond
Duke University Medical Center, Durham
Shands Teaching Hospital, University of Florida, Gainesville
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Case Western Reserve University, Cleveland
Cleveland Clinic Foundation, Cleveland
Indiana Blood and Marrow Transplantation Center, Beech Grove
University of Iowa Hospitals and Clinics, Iowa City
University of Minnesota, Minneapolis
Mayo Clinic, Rochester
Loyola University Medical Center, Maywood
Washington University School of Medicine, St Louis
Kansas City Cancer Center, Kansas City
Nebraska Medical Center: Clarkson and University Hospitals, Omaha
The University of Texas MD Anderson Cancer Center, Houston
Texas Transplant Institute, San Antonio
University of Texas Health Science Center, San Antonio
Wilford Hall Medical Center, Lackland Air Force Base
Rocky Mountain Cancer Center, Denver
City of Hope Samaritan Bone Marrow Transplant Program, Phoenix
City of Hope National Medical Center, Duarte
Oregon Health & Science University, Portland
Fred Hutchinson Cancer Research Center, Seattle
Yale University School of Medicine, New Haven
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
Dana-Farber Cancer Institute, Boston
Vancouver General Hospital, Vancouver
Genzyme, a Sanofi Company
INDUSTRY