302
Participants
Start Date
January 31, 2005
Primary Completion Date
October 31, 2006
Study Completion Date
January 31, 2008
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 ≥ 6\*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 ≥ 6\*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.
St. Vincent's Comprehensive Cancer Center, New York
New York Hospital, New York
Memorial Sloan Kettering, New York
Roswell Park Cancer Institute, Buffalo
University of Rochester Medical Center, Rochester
Hospital of the University of Pennsylvania, Philadelphia
Thomas Jefferson University, Philadelphia
Virginia Commonwealth University, Richmond
Duke University Medical Center, Durham
Emory University, Atlanta
University of Florida, Gainesville
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Ohio State University, Columbus
Case Western Reserve University, Cleveland
Cleveland Clinic Foundation, Cleveland
Indiana Blood and Marrow Transplantation Center, Beech Grove
University of Iowa Hosptials and Clinics, Iowa City
Fairview-University Medical Center, University of Minnesota, Minneapolis
Mayo Clinic, Rochester
Loyola University Medical Center, Maywood
Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia, St Louis
Kansas City Cancer Center, Kansas City
Universitätsklinikum Heidelberg,, Heidelberg
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock
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
Utah Blood and Marrow Transplant Program, University of Utah, Salt Lake City
City of Hope Samaritan Bone Marrow Transplant Program, Phoenix
Cedars-Sinai, Los Angeles
University of California, Los Angeles
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
The Cancer Center at Hackensack University Medical Center, Hackensack
Vancouver General Hospital, Vancouver
Genzyme, a Sanofi Company
INDUSTRY