Vinorelbine combined with filgrastim at a dose of 10 µg/kg of body weight (BW) per day is a reliable and well-tolerated regimen for mobilization of hematopoietic progenitor cells (HPCs) in patients with multiple myeloma. This prospective, randomized, phase II study was initiated to assess the feasibility of a reduced filgrastim dosage. Vinorelbine was combined with either standard-dose filgrastim (10 µg/kg BW per day) or reduced-dose filgrastim (5 µg/kg BW per day). Leukapheresis sessions were planned to start at day 8 and were continued until the predefined target amount of 4 × 10 6 HPCs/kg BW was collected. The study demonstrated the feasibility of vinorelbine combined with reduced daily filgrastim with a mean of 1.29 leukapheresis sessions necessary per patient (95% confidence interval,.95 to 1.7). All patients could start leukapheresis as planned at day 8, and the collection success rate was 100% for the whole patient collective after a maximum of 2 leukapheresis sessions. No statistically significant differences with regard to the amount of HPCs collected between the 2 groups were observed (P =.99). Accordingly, no differences were seen with regard to length of hospitalization for autotransplant (P =.34) and duration of neutrophil (P =.93) and platelet engraftment (P =.42). Patients receiving reduced-dose filgrastim reported significantly lower peak pain values in a numeric analogue scale (P =.01), and the costs were significantly lower than in patients undergoing standard-dose chemomobilization (P =.001). Vinorelbine 35 mg/m 2 plus filgrastim 5 µg/kg BW once per day until completion of HPC collection is feasible and appears to be advantageous with respect to the severity of pain intensity and treatment costs.
Samaras, P., Rütti, M. F., Seifert, B., Bachmann, H., Schanz, U., Eisenring, M., … Stenner-Liewen, F. (2018). Mobilization of Hematopoietic Progenitor Cells with Standard- or Reduced-Dose Filgrastim after Vinorelbine in Multiple Myeloma Patients: A Randomized Prospective Single-Center Phase II Study. Biology of Blood and Marrow Transplantation, 24(4), 694–699. https://doi.org/10.1016/j.bbmt.2017.12.775