1. Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial
- Author
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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, and Akifumi Takaori-Kondo
- Subjects
multiple myeloma ,bortezomib ,cyclophosphamide ,autologous stem cell transplantation ,induction therapy ,consolidation therapy ,maintenance therapy ,japan ,Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
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.
- Published
- 2022
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