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<p>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 (<i>n</i> = 30) or daily filgrastim (<i>n</i> = 31), and ML (pegfilgrastim only, <i>n</i> = 13) cohorts. In the MM cohort, CD34-positive cell counts ≥ 2 × 10<sup>6</sup>/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<sup>6</sup>/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.</p><p>Trial Registration: jRCT2011210029, NCT05007652. </p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月25日

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

摘要

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 × 106/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 × 106/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.