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

doi:10.1038/sj.bmt.1702662

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

Medical Education

Research output: Contribution to journal › Article › peer-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 language	English (US)
Pages (from-to)	1083-1088
Number of pages	6
Journal	Bone Marrow Transplantation
Volume	26
Issue number	10
DOIs	https://doi.org/10.1038/sj.bmt.1702662
State	Published - 2000

Keywords

Clinical trial
Engraftment
PEG-rHuMGDF
Platelet
Transplantation

ASJC Scopus subject areas

Transplantation
Hematology

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10.1038/sj.bmt.1702662

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title = "Use of PEG-rHuMGDF in platelet angraftment after autologous stem cell transplantation",

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.",

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AU - Fields, K. K.

AU - Crump, M.

AU - Bence-Bruckler, I.

AU - Bernstein, S.

AU - Williams, S.

AU - Frankel, S.

AU - Miller, A.

AU - Demetri, G.

AU - Nabholtz, J. M.

AU - Cruickshank, S.

AU - Lill, M.

PY - 2000

Y1 - 2000

N2 - 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.

AB - 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.

KW - Clinical trial

KW - Engraftment

KW - PEG-rHuMGDF

KW - Platelet

KW - Transplantation

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

Abstract

Keywords

ASJC Scopus subject areas

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