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 Maziarz, Chitra Hosing, Stefan Früehauf, Mitchell Horwitz, Dennis Cooper, Gary Bridger, Gary Calandra

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)5720-5726
Number of pages7
JournalBlood
Volume113
Issue number23
DOIs
StatePublished - 2009

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Stem Cell Transplantation
Granulocyte Colony-Stimulating Factor
Hematopoietic Stem Cells
Stem cells
Multiple Myeloma
Placebos
Blood Component Removal
JM 3100
Transplantation
Safety
Injections

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

Cite this

DiPersio, J. F., Stadtmauer, E. A., Nademanee, A., Micallef, I. N. M., Stiff, P. J., Kaufman, J. L., ... Calandra, G. (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. Blood, 113(23), 5720-5726. https://doi.org/10.1182/blood-2008-08-174946

Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. / DiPersio, John F.; Stadtmauer, Edward A.; Nademanee, Auayporn; Micallef, Ivana N M; Stiff, Patrick J.; Kaufman, Jonathan L.; Maziarz, Richard; Hosing, Chitra; Früehauf, Stefan; Horwitz, Mitchell; Cooper, Dennis; Bridger, Gary; Calandra, Gary.

In: Blood, Vol. 113, No. 23, 2009, p. 5720-5726.

Research output: Contribution to journalArticle

DiPersio, JF, Stadtmauer, EA, Nademanee, A, Micallef, INM, Stiff, PJ, Kaufman, JL, Maziarz, R, Hosing, C, Früehauf, S, Horwitz, M, Cooper, D, Bridger, G & Calandra, G 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', Blood, vol. 113, no. 23, pp. 5720-5726. https://doi.org/10.1182/blood-2008-08-174946
DiPersio, John F. ; Stadtmauer, Edward A. ; Nademanee, Auayporn ; Micallef, Ivana N M ; Stiff, Patrick J. ; Kaufman, Jonathan L. ; Maziarz, Richard ; Hosing, Chitra ; Früehauf, Stefan ; Horwitz, Mitchell ; Cooper, Dennis ; Bridger, Gary ; Calandra, Gary. / Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. In: Blood. 2009 ; Vol. 113, No. 23. pp. 5720-5726.
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abstract = "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.",
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T1 - Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma

AU - DiPersio, John F.

AU - Stadtmauer, Edward A.

AU - Nademanee, Auayporn

AU - Micallef, Ivana N M

AU - Stiff, Patrick J.

AU - Kaufman, Jonathan L.

AU - Maziarz, Richard

AU - Hosing, Chitra

AU - Früehauf, Stefan

AU - Horwitz, Mitchell

AU - Cooper, Dennis

AU - Bridger, Gary

AU - Calandra, Gary

PY - 2009

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