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<p>This single-arm phase 2 trial investigated the efficacy and safety of bortezomib-lenalidomide-dexamethasone (VRD) induction for transplant-eligible Japanese patients with newly diagnosed multiple myeloma. Treatment consisted of four cycles of VRD (bortezomib 1.3&#xa0;mg/m<sup>2</sup>, s.c., days 1, 4, 8, 11; lenalidomide 25 mg/body/day, days 1–14; dexamethasone 40&#xa0;mg/day, p.o., days 1, 4, 8, 11), stem cell mobilization with low-dose cyclophosphamide (1&#xa0;g/m<sup>2</sup>, day 1) and bortezomib (1.3&#xa0;mg/m<sup>2</sup>, days 4, 7), and high-dose therapy with melphalan supported by autologous peripheral blood stem cell transplantation. Primary endpoints were post-induction complete response (CR) and near CR (nCR) rates. Seven of the 23 enrolled patients discontinued induction therapy, including 5 due to grade 3 or 4 non-hematologic toxicities. Moreover, 8 of the 16 patients who completed induction therapy required dose reduction. Post-induction CR and nCR rates in the intent-to-treat population were 17.4% and 8.7%, respectively. Comparison of pre- and post-induction quality of life (QoL) indicators, such as QLQ-C30 and QLQ-MY20, revealed that VRD induction does not adversely affect QoL in patients who tolerate the treatment. Collectively, these findings indicate a need to optimize the dose and schedule of VRD induction, at least in Japanese patients.</p>

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A phase 2 trial of VRD induction for transplant-eligible Japanese patients with newly diagnosed multiple myeloma

  • 期刊论文

  • 发表日期：

    2025年5月20日

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  • Ikuyo Tsutsumi,
  • Masahide Yamamoto,
  • Takayuki Fujio,
  • Nobuharu Kosugi,
  • Gaku Oshikawa,
  • Koh Yamamoto,
  • Takasi Kumagai,
  • Toru Miki,
  • Daisuke Kudo,
  • Shigeo Toyota,
  • Yuichi Nakamura,
  • Nobutaka Kawai,
  • Masao Hagiwara,
  • Takeshi Kobayashi,
  • Ayako Arai,
  • Takuya Komeno,
  • Hiroshi Kojima

摘要

This single-arm phase 2 trial investigated the efficacy and safety of bortezomib-lenalidomide-dexamethasone (VRD) induction for transplant-eligible Japanese patients with newly diagnosed multiple myeloma. Treatment consisted of four cycles of VRD (bortezomib 1.3 mg/m2, s.c., days 1, 4, 8, 11; lenalidomide 25 mg/body/day, days 1–14; dexamethasone 40 mg/day, p.o., days 1, 4, 8, 11), stem cell mobilization with low-dose cyclophosphamide (1 g/m2, day 1) and bortezomib (1.3 mg/m2, days 4, 7), and high-dose therapy with melphalan supported by autologous peripheral blood stem cell transplantation. Primary endpoints were post-induction complete response (CR) and near CR (nCR) rates. Seven of the 23 enrolled patients discontinued induction therapy, including 5 due to grade 3 or 4 non-hematologic toxicities. Moreover, 8 of the 16 patients who completed induction therapy required dose reduction. Post-induction CR and nCR rates in the intent-to-treat population were 17.4% and 8.7%, respectively. Comparison of pre- and post-induction quality of life (QoL) indicators, such as QLQ-C30 and QLQ-MY20, revealed that VRD induction does not adversely affect QoL in patients who tolerate the treatment. Collectively, these findings indicate a need to optimize the dose and schedule of VRD induction, at least in Japanese patients.