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

K. K. Fields*, M. Crump, I. Bence-Bruckler, S. Bernstein, S. Williams, S. Frankel, A. Miller, G. Demetri, J. M. Nabholtz, S. Cruickshank, M. Lill

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

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 x 109/I 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.

Original languageEnglish (US)
Pages (from-to)1083-1088
Number of pages6
JournalBone Marrow Transplantation
Volume26
Issue number10
DOIs
StatePublished - 2000
Externally publishedYes

Keywords

  • Clinical trial
  • Engraftment
  • PEG-rHuMGDF
  • Platelet
  • Transplantation

ASJC Scopus subject areas

  • Hematology
  • Transplantation

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