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Title: Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial
Authors: Muranushi, Hiroyuki
Kanda, Junya  kyouindb  KAKEN_id  orcid https://orcid.org/0000-0002-6704-3633 (unconfirmed)
Kobayashi, Masayuki
Maeda, Takeshi
Kitano, Toshiyuki
Tsuji, Masaaki
Ueda, Yasunori
Ishikawa, Takayuki
Nohgawa, Masaharu
Watanabe, Mitsumasa
Imada, Kazunori
Moriguchi, Toshinori
Itoh, Mitsuru
Ohno, Hitoshi
Yonezawa, Akihito
Hirata, Hirokazu
Arima, Nobuyoshi
Asagoe, Kohsuke
Anzai, Naoyuki
Nagata, Kayoko
Yasuno, Shinji
Kuwabara, Yoshihiro
Kitao, Hiromi
Kim, Ihhwa
Kawagishi, Kiyomi
Ueshima, Kenji
Tominari, Shinjiro
Nakayama, Takeo  kyouindb  KAKEN_id  orcid https://orcid.org/0000-0002-7918-6252 (unconfirmed)
Yamashita, Kouhei
Takaori-Kondo, Akifumi
Author's alias: 村主, 啓行
諫田, 淳也
小林, 正行
永田, 佳代子
上嶋, 健治
富成, 伸次郎
中山, 健夫
山下, 浩平
髙折, 晃史
Keywords: Multiple myeloma
bortezomib
cyclophosphamide
autologous stem cell transplantation
induction therapy
consolidation therapy
maintenance therapy
Japan
Issue Date: 2022
Publisher: Taylor & Francis
Journal title: Hematology
Volume: 27
Issue: 1
Start page: 239
End page: 248
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.
Rights: © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group
This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrest-ricted use, distribution, and reproduction in any medium, provided the original work is properly cited
URI: http://hdl.handle.net/2433/277938
DOI(Published Version): 10.1080/16078454.2022.2032915
PubMed ID: 35152852
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