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  • Original Article
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Myeloid Reconstitution

Use of PEG-rHuMGDF in platelet engraftment after autologous stem cell transplantation

Bone Marrow Transplantation volume 26, pages 1083–1088 (2000)Cite this article

Abstract

This paper summarizes a pilot, sequential dose-escalation study of PEG-rHuMGDF in patients with advanced malignancies who had delayed platelet recovery after autologous stem cell transplantation (ASCT). Patients were randomized to receive either placebo (n = 11) or PEG-rHuMGDF at 5 (n = 9), 10 (n = 6), or 25 (n = 7) μg/kg/day by subcutaneous injection for 14 days and were monitored for 5 weeks. Across all treatment groups, eight patients had platelet recovery to ⩾20 × 109/l by day 21. The proportion of patients achieving platelet recovery, the median number of days and units of platelet transfusions were similar for the placebo and the PEG-rHuMGDF groups. PEG-rHuMGDF was well tolerated at all dosages. The incidence rates of adverse events in all groups were similar. No deaths on study, no drug-related serious adverse events, and no development of neutralizing antibodies to MGDF occurred. Bone Marrow Transplantation (2000) 26, 1083–1088.

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Acknowledgements

The authors wish to thank Drs Stefan Gluck, Pierre Laneuville, Adrian Langleben, John Shephard, James Vredenburgh, and Daniel Weisdorf for scientific guidance, the respective study coordinators of each participating institution for data management, and Catherine Allen for study monitoring and management. Janet Lee Nichol, MS and MaryAnn Foote, PhD assisted with the writing of this manuscript.

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Authors and Affiliations

  1. H Lee Moffitt Cancer Center, Tampa, FL, USA

    KK Fields

  2. The Toronto Hospital, Toronto, ON, Canada

    M Crump

  3. Ottawa General Hospital, Ottawa, ON, Canada

    I Bence-Bruckler

  4. Roswell Park Cancer Institute, Buffalo, NY, USA

    S Bernstein

  5. University of Chicago Medical Center, Chicago, IL, USA

    S Williams

  6. Georgetown University Medical Center, Washington DC, USA

    S Frankel

  7. Tulane University Medical Center, New Orleans, LA, USA

    A Miller

  8. Dana-Farber Cancer Institute, Boston, MA, USA

    G Demetri

  9. Cross Cancer Center, Edmonton, AB, Canada

    J-M Nabholtz

  10. Amgen Inc, Thousand Oaks, CA, USA

    S Cruickshank

  11. Cedars Sinai Medical Center, Los Angeles, CA, USA

    M Lill

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  1. KK Fields
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Fields, K., Crump, M., Bence-Bruckler, I. et al. Use of PEG-rHuMGDF in platelet engraftment after autologous stem cell transplantation. Bone Marrow Transplant 26, 1083–1088 (2000). https://doi.org/10.1038/sj.bmt.1702662

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  • DOI: https://doi.org/10.1038/sj.bmt.1702662

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