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Blood, 4 June 2009, Vol. 113, No. 23, pp. 5720-5726. Prepublished online as a Blood First Edition Paper on April 10, 2009; DOI 10.1182/blood-2008-08-174946. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2008-08-174946v1 113/23/5720    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by DiPersio, J. F. Articles by Calandra, G. Search for Related Content PubMed PubMed Citation Articles by DiPersio, J. F. Articles by Calandra, G. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted August 18, 2008 Accepted March 25, 2009 Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma John F. DiPersio*, Edward A. Stadtmauer, Auayporn Nademanee, Ivana N.M. Micallef, Patrick J. Stiff, Jonathan L. Kaufman, Richard T. Maziarz, Chitra Hosing, Stefan Fruehauf, Mitchell Horwitz, Dennis Cooper, Gary Bridger, and Gary Calandra Washington University, St. Louis, MO, United States Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, United States City of Hope Comprehensive Cancer Center, Duarte, CA, United States Mayo Clinic, Rochester, MN, United States Loyola University, Chicago, IL, United States Emory University, Atlanta, GA, United States Oregon Health & Science University, Portland, OR, United States MD Anderson Cancer Center, Houston, TX, United States Universitatsklinikum Heidelberg, Heidelberg, Germany Duke University Medical Center, Durham, NC, United States Yale University School of Medicine, New Haven, CT, United States Genzyme Corporation, Cambridge, MA, United States * Corresponding author; email: jdipersi{at}im.wustl.edu. This phase 3, multi-center, randomized (1:1), double-blind, placebo-controlled study evaluated the safety and efficacy of plerixafor with G-CSF in mobilizing hematopoietic stem cells in patients with multiple myeloma. Patients received G-CSF (10µg/kg) subcutaneously daily for up to 8 days. Beginning on Day 4 and continuing daily for up to 4 days, patients received either plerixafor (0.24 mgg/kg) or placebo subcutaneously. Starting on Day 5, patients began daily apheresis for up to 4 days or until 6 x 106 CD34+cells/kg were collected. The primary endpoint was the percentage of patients who collected 6 x 106 CD34+cells/kg in 2 aphereses. 106/148 (71.6%) patients in the plerixafor group and 53/154 (34.4%) patients in the placebo group met the primary endpoint, p<0.001. 54% of plerixafor-treated patients reached target after 1 apheresis while 56% of the placebo-treated patients required 4 aphereses to reach target. 96% of the plerixafor-treated patients and 88% of the placebo-treated patients underwent transplantation. Engraftment was similar and durable between the two groups. The most common adverse events related to plerixafor were gastrointestinal disorders and injection site reactions. Plerixafor and G-CSF was well tolerated and significantly more patients collected the optimal CD34+ cell/kg target for transplant earlier compared to G-CSF alone. This study is registered with www.clinicaltrials.gov as NCT00103662. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: A. K. Azab and I. M. Ghobrial Response: Sensitization initiated Blood, July 23, 2009; 114(4): 926 - 927. [Full Text] [PDF]

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