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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.
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CLINICAL TRIALS AND OBSERVATIONS
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. DiPersio1,
Edward A. Stadtmauer2,
Auayporn Nademanee3,
Ivana N. M. Micallef4,
Patrick J. Stiff5,
Jonathan L. Kaufman6,
Richard T. Maziarz7,
Chitra Hosing8,
Stefan Früehauf9,
Mitchell Horwitz10,
Dennis Cooper11,
Gary Bridger12,
Gary Calandra12, and
for the 3102 Investigators
1 Washington University, St Louis, MO;
2 Abramson Cancer Center of the University of Pennsylvania, Philadelphia;
3 City of Hope Comprehensive Cancer Center, Duarte, CA;
4 Mayo Clinic, Rochester, MN;
5 Loyola University, Chicago, IL;
6 Emory University, Atlanta, GA;
7 Oregon Health & Science University, Portland;
8 M. D. Anderson Cancer Center, Houston, TX;
9 Universitätsklinikum Heidelberg, Heidelberg, Germany;
10 Duke University Medical Center; Durham, NC;
11 Yale University School of Medicine; New Haven, CT; and
12 Genzyme Corporation (formerly AnorMED Inc), Cambridge, MA
This phase 3, multicenter, randomized (1:1), double-blind, placebo-controlled study evaluated the safety and efficacy of plerixafor with granulocyte colony-stimulating factor (G-CSF) in mobilizing hematopoietic stem cells in patients with multiple myeloma. Patients received G-CSF (10 µg/kg) subcutaneously daily for up to 8 days. Beginning on day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 µg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until more than or equal to 6 x 106 CD34+ cells/kg were collected. The primary endpoint was the percentage of patients who collected more than or equal to 6 x 106 CD34+ cells/kg in less than or equal to 2 aphereses. A total of 106 of 148 (71.6%) patients in the plerixafor group and 53 of 154 (34.4%) patients in the placebo group met the primary endpoint (P < .001). A total of 54% of plerixafor-treated patients reached target after one apheresis, whereas 56% of the placebo-treated patients required 4 aphereses to reach target. The most common adverse events related to plerixafor were gastrointestinal disorders and injection site reactions. Plerixafor and G-CSF were well tolerated, and significantly more patients collected the optimal CD34+ cell/kg target for transplantation earlier compared with G-CSF alone. This study is registered at www.clinicaltrials.gov as #NCT00103662
[ClinicalTrials.gov]
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