Efficacy and safety of plerixafor for the mobilization/collection of peripheral hematopoietic stem cells for autologous transplantation in Japanese patients with multiple myeloma
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To evaluate the efficacy and safety of plerixafor for the mobilization/collection of peripheral hematopoietic stem cells (HSCs) for autologous transplantation in Japanese patients with multiple myeloma (MM). In a randomized study, patients received G-CSF (filgrastim, 400 µg/m2/day) for 4 days prior to the first dose of plerixafor. Starting on Day 4 evening and for up to 4 days, patients received either plerixafor (240 µg/kg/day) + G-CSF group (PG group) or G-CSF alone (G group). Daily apheresis started on Day 5 for up to 4 days, or until ≥6 × 106 CD34+ cells/kg were collected. A total of 7 patients were randomized in each treatment group. Five patients in PG group and no patients in G group achieved a collection of ≥6 × 106 CD34+ cells/kg in ≤2 days of apheresis [difference of 71.4% (90%CI 29–100%)]. These results were supported by the shorter median time to collect ≥6 × 106 CD34+ cells/kg (2 days in PG group; no patient in G group). The incidence of treatment emergent adverse events (TEAEs) was higher in PG group than in G group. Plerixafor was well tolerated, and effective for the mobilization/collection of peripheral HSCs for autologous transplantation in Japanese patients with MM.
KeywordsPlerixafor G-CSF Multiple myeloma Stem cell Apheresis
Financial support for this study was provided by Sanofi K.K., Tokyo, Japan. Medical writing support was provided by Honyaku Center Inc. and funded by Sanofi K.K. All authors agreed to the content of the manuscript.
Compliance with ethical standards
Conflict of interest
M. Ri has received grants from Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology, and has received honoraria from Celgene K.K. and Janssen Pharmaceutical K.K. K. Sunami has received research funding from Sanofi K.K., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., Bristol-Myers Squibb K.K., Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., Ltd. and Ono Pharmaceutical Co., Ltd., and has received honoraria and research funding from Celgene K.K. C. Shimazaki has received consulting fees from Fujimoto Pharmaceutical and Ono Pharmaceutical Co., Ltd. and has received speaking fees from Celgene K.K. and Janssen Pharmaceutical K.K. A. Hayashi, Y. Sunaga and T. Sasaki are employees of Sanofi K.K. The other authors have no conflicts of interest to declare.
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