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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 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 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 |
Appears in Collections: | Journal Articles |
This item is licensed under a Creative Commons License