Hematology (Dec 2022)

Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial

  • Hiroyuki Muranushi,
  • Junya Kanda,
  • Masayuki Kobayashi,
  • Takeshi Maeda,
  • Toshiyuki Kitano,
  • Masaaki Tsuji,
  • Yasunori Ueda,
  • Takayuki Ishikawa,
  • Masaharu Nohgawa,
  • Mitsumasa Watanabe,
  • Kazunori Imada,
  • Toshinori Moriguchi,
  • Mitsuru Itoh,
  • Hitoshi Ohno,
  • Akihito Yonezawa,
  • Hirokazu Hirata,
  • Nobuyoshi Arima,
  • Kohsuke Asagoe,
  • Naoyuki Anzai,
  • Kayoko Nagata,
  • Shinji Yasuno,
  • Yoshihiro Kuwabara,
  • Hiromi Kitao,
  • Ihhwa Kim,
  • Kiyomi Kawagishi,
  • Kenji Ueshima,
  • Shinjiro Tominari,
  • Takeo Nakayama,
  • Kouhei Yamashita,
  • Akifumi Takaori-Kondo

DOI
https://doi.org/10.1080/16078454.2022.2032915
Journal volume & issue
Vol. 27, no. 1
pp. 239 – 248

Abstract

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Objectives: We conducted a phase II trial to prospectively evaluate the efficacy and safety of bortezomib-cyclophosphamide-dexamethasone (VCD) induction, autologous stem cell transplantation (ASCT), VCD consolidation, and bortezomib maintenance in transplant-eligible newly diagnosed multiple myeloma (NDMM) patients in Japan (UMIN000010542). Methods: From 2013 to 2016, 42 patients with a median age of 58 (range 42–65) years with NDMM were enrolled in 15 centers. The primary endpoint was the complete response (CR) /stringent CR (sCR) rate after transplantation, and overall/progression-free survival rates were also evaluated. Results: Following induction therapy, the overall response rate was obtained in 71% of patients, including a CR/sCR of 10% and a very good partial response (VGPR) of 26%. Twenty-six of the 42 patients completed ASCT following the protocol and CR/sCR and VGPR rate 100 days after ASCT was 26% and 17%, respectively. During consolidation therapy, 3 of the 24 patients achieved deeper responses. Eight of the 18 patients completed 2-year bortezomib maintenance without disease progression and grade 3/4 toxicities. Five patients were VGPR or partial response after ASCT but maintained response with 2-year bortezomib maintenance. Two-year overall and progression-free survival rates were 92.5% (95% confidence interval [CI]: 78.5%−97.5%) and 62.6% (95% CI: 45.8%−75.5%), respectively. Grade 3/4 toxicities (≥ 10%) included neutropenia (19%) and anemia (17%) in induction, and thrombocytopenia (29%) in consolidation. Conclusion: VCD induction/consolidation and bortezomib maintenance with ASCT for NDMM resulted in a high CR/sCR rate and provided good overall/progression-free survival in Japan.

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