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Long-acting granulocyte colony-stimulating factor pegfilgrastim (lipegfilgrastim) for stem cell mobilization in multiple myeloma patients undergoing autologous stem cell transplantation

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Abstract

Autologous stem cell transplantation (ASCT) is a standard of care in newly-diagnosed multiple myeloma (MM) patients. Several studies before the introduction of novel therapies in MM, demonstrated a pegylated G-CSF to be successful in mobilizing peripheral blood stem cells (PBSCs). Lipegfilgrastim is a novel long-acting G-CSF that is produced by the conjugation of a single 20-kDa polyethelene glycol to the natural O-glycosylation site of G-CSF. Twenty-four MM patients were included for PBSCs mobilization with a single SC injection of 6 mg lipegfilgrastim. PBSC collection was started when the CD34+ count was > 10 × 106 cells/L. The target progenitor cells were 6 × 106 cells/kg. The median day of apheresis was + 3 (range 2–5) following lipegfilgrastim. Median peripheral blood CD34+ count pre-mobilization was of 22.65 (range 3.36–105) × 106 cells/L. The median number of leukaphaeresis procedures was 2 (range 1–4). The median mobilized CD34+ cells/kg were 8.26 (range 0.77–12.42). One patient failed to mobilize and two patients mobilized < 6 × 106 cells/kg. Toxicity was mild and transient. Twenty-three patients underwent ASCT following high dose melphalan. All patients engrafted. As lipegfilgrastim is administered only once, it is conceivable that it improves both compliance and quality-of-life (NCT02488382).

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Acknowledgements

The authors thank and acknowledge the contribution of all centers referring patients to this study. This investigator-initiated study was supported by an academic Grant from Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel (A.N). Teva Pharmaceutical Industries Ltd also supplied the lipegfilgrastim used in the investigation. The funder of the study had no role in study design, data collection and analysis, and manuscript writing. The primary investigator had full access to all data and had the final responsibility for the submission of the publication.

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Authors and Affiliations

  1. The Division of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel

    Ivetta Danylesko, Rina Sareli, Nira Varda-Bloom, Ronit Yerushalmi, Noga Shem-Tov, Hila Magen, Avichai Shimoni & Arnon Nagler

  2. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

    Ivetta Danylesko, Rina Sareli, Nira Varda-Bloom, Ronit Yerushalmi, Noga Shem-Tov, Hila Magen, Avichai Shimoni & Arnon Nagler

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  1. Ivetta Danylesko
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Danylesko, I., Sareli, R., Varda-Bloom, N. et al. Long-acting granulocyte colony-stimulating factor pegfilgrastim (lipegfilgrastim) for stem cell mobilization in multiple myeloma patients undergoing autologous stem cell transplantation. Int J Hematol 114, 363–372 (2021). https://doi.org/10.1007/s12185-021-03177-9

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