Use of PEG-rHuMGDF in platelet engraftment after autologous stem cell transplantation.
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.
Fields
K K
KK
H Lee Moffitt Cancer Center, Tampa, FL 33617, USA.
Crump
M
M
Bence-Bruckler
I
I
Bernstein
S
S
Williams
S
S
Frankel
S
S
Miller
A
A
Demetri
G
G
Nabholtz
J M
JM
Cruickshank
S
S
Lill
M
M
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011994:Recombinant Proteins / Q000494:pharmacology; D013921:Thrombocytopenia / Q000188:drug therapy*; D013926:Thrombopoietin / Q000494:pharmacology*; D014182:Transplantation, Autologous
D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D013926:Thrombopoietin