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  • Title: Use of PEG-rHuMGDF in platelet engraftment after autologous stem cell transplantation.
    Author: Fields KK, Crump M, Bence-Bruckler I, Bernstein S, Williams S, Frankel S, Miller A, Demetri G, Nabholtz JM, Cruickshank S, Lill M.
    Journal: Bone Marrow Transplant; 2000 Nov; 26(10):1083-8. PubMed ID: 11108307.
    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) microg/kg/day by subcutaneous injection for 14 days and were monitored for 5 weeks. Across all treatment groups, eight patients had platelet recovery to > or = 20 x 10(9)/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.
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