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

This paper summarizes a pilot, sequential dose-escalation study of PEG-rHuM GDF in patients with advanced malignancies who had delayed platelet recover y after autologous stem cell transplantation (ASCT), Patients were randomiz ed to receive either placebo (n = 11) Or PEG-rHuMGDF at 5 (n = 9), 10 (n = 6), or 25 (n = 7) mug/kg/day by subcutaneous injection for 14 days and were monitored for 5 weeks. Across all treatment groups, eight patients had pla telet recovery to greater than or equal to 20 x 10(9)/l by day 21, The prop ortion of patients achieving platelet recovery, the median number of days a nd units of platelet transfusions were similar for the placebo and the PEG- rHuMGDF groups. PEG-rHuMGDF was well tolerated at all dosages, The incidenc e rates of adverse events in all groups were similar. No deaths on study, n o drug-related serious adverse events, and no development of neutralizing a ntibodies to MGDF occurred.