Journal Article

Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma

Sonoki, Takashi, Tsukada, Junichi, Takeuchi, Masahiro, Goto, Hideki, Fujiwara, Shin-ichiro, Ishitsuka, Kenji, Teshima, Takanori, Ouchi, Yoshiumi, Ri, Masaki, Ishida, Tadao, Miyamoto, Toshihiro, Sunami, Kazutaka, Sawa, Masashi, Maeda, Yoshinobu, Shimogomi, Aiko, Hino, Masayuki, Ichihashi, Yuki, Toyosaki, Masako

2025

Overview

This phase 2 study evaluated the impact of pegfilgrastim, a single-dose, long-acting granulocyte colony-stimulating factor, on the steady-state mobilization of hematopoietic stem cells into peripheral blood in patients with multiple myeloma (MM) or malignant lymphoma (ML). Efficacy and safety, along with CD34-positive cell mobilization outcomes were assessed in patients with MM, who were randomly assigned to pegfilgrastim ( n  = 30) or daily filgrastim ( n  = 31), and ML (pegfilgrastim only, n  = 13) cohorts. In the MM cohort, CD34-positive cell counts ≥ 2 × 10 6 /kg were achieved in 100% of patients in the pegfilgrastim group and 96.7% in the filgrastim group (difference: 3.3%; 80% confidence interval: −0.9–7.5%), demonstrating the non-inferiority of pegfilgrastim to filgrastim. All patients in the ML cohort achieved ≥ 2 × 10 6 /kg CD34-positive cell counts. The plerixafor administration rates in the MM cohort were 50.0% and 63.3% in the pegfilgrastim and filgrastim groups, respectively, and 91.7% in the ML cohort. There were no major differences in safety measures between the two groups. Although the sample size was small, particularly in the ML cohort, a single dose of pegfilgrastim demonstrated comparable efficacy and safety to daily doses of filgrastim, indicating its potential for clinical use while reducing patient burden. Trial Registration: jRCT2011210029, NCT05007652.

• Publisher: Nature Publishing Group UK,Nature Portfolio
• Subject: 692/308/2779/109 / 692/699/67/1990/804 / Adult / Aged / Antigens, CD34 - metabolism / Benzylamines / CD34 / Cyclams / Female / Filgrastim - administration & dosage / Filgrastim - adverse effects / Hematopoietic Stem Cell Mobilization - adverse effects / Hematopoietic Stem Cell Mobilization - methods / Humanities and Social Sciences / Humans / Lymphoma / Lymphoma - drug therapy / Lymphoma - therapy / Male / Middle Aged / Mobilization / multidisciplinary / Multiple myeloma / Multiple Myeloma - drug therapy / Multiple Myeloma - therapy / Pegfilgrastim / Peripheral blood stem cell / Peripheral Blood Stem Cells - cytology / Peripheral Blood Stem Cells - drug effects / Polyethylene Glycols - administration & dosage / Polyethylene Glycols - adverse effects / Science / Science (multidisciplinary)