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Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma: a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12)

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Abstract

Background

The Japan Study Group for Cell Therapy and Transplantation (JSCT) organized a phase II study to evaluate the efficacy and safety of a treatment protocol (JSCT-MM12) for multiple myeloma (MM) patients who were previously untreated and transplantation-eligible. Since bortezomib-based therapy is known to be effective for MM, the protocol is intensified more than the previous protocol (JSCT-MM10) and comprised the subsequent treatments: bortezomib + cyclophosphamide + dexamethasone (VCD) induction; bortezomib + high-dose-melphalan (B-HDM) conditioning with autologous stem cell transplantation (ASCT); bortezomib + thalidomide + dexamethasone (VTD) consolidation; and lenalidomide (LEN) maintenance.

Methods

Sixty-four symptomatic patients aged between 20 and 65 years were enrolled for treatment and received three cycles of VCD, followed by cyclophosphamide administration for autologous stem cell harvest and B-HDM/ASCT, and subsequently two cycles of VTD, after that LEN for 1 year.

Results

Complete response (CR)/stringent CR (sCR) rates for induction, ASCT, consolidation, and maintenance therapies were 20, 39, 52, and 56%, respectively. The grade 3/4 toxicities (≥ 10%) with VCD treatment included neutropenia (27%), anemia (19%), and thrombocytopenia (11%). There was no treatment-related mortality. After median follow-up of 41 months, estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 64% and 88%, respectively. The high-risk group revealed lower CR/sCR, PFS, and OS than the standard-risk group.

Conclusions

The study revealed that the treatment protocol consisting of VCD induction, B-HDM/ASCT followed by VTD consolidation, and LEN maintenance could produce highly beneficial responses and favorable tolerability in newly diagnosed MM. However, future study is required for improving treatment in the high-risk group.

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Acknowledgements

We are grateful to Professor Koji Yonemoto (Ryukyu University) for the data analysis. This work was supported by a grant from the Regional Medicine Research Foundation (Tochigi, Japan).

Author information

Authors and Affiliations

  1. Department of Hematology, National Hospital Organization Okayama Medical Center, 1711-1 Tamasu, Kita-ku, Okayama, 701-1192, Japan

    Kazutaka Sunami

  2. Department of Hematology, National Hospital Organization Shibukawa Medical Center, 383 Shirai, Shibukawa, Gunma, 377-0280, Japan

    Morio Matsumoto

  3. Department of Hematology, Japan Community Health Care Organization Kyoto Kuramaguchi Medical Center, 27 Shimofusa-cho, Koyama, Kita-ku, Kyoto, 603-8151, Japan

    Shin-ichi Fuchida

  4. Department of Hematology, Yamagata Prefectural Central Hospital, 1800 Aoyagi, Yamagata, 990-2292, Japan

    Eijiro Omoto

  5. Department of Hematology/Respiratory Medicine, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, 13-1 Takaramachi, Kanazawa, Ishikawa, 920-8641, Japan

    Hiroyuki Takamatsu

  6. Department of Internal Medicine, Japan Community Health Care Organization Kobe Central Hospital, 2-1-1 Soyama-cho, Kita-ku, Kobe, Hyogo, 651-1145, Japan

    Yoko Adachi

  7. Department of Hematology, National Hospital Organization Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka, 811-1395, Japan

    Ilsong Choi

  8. Division of Blood Transfusion, Akita University Hospital, 1-1-1 Hondo, Akita, 010-8543, Japan

    Naohito Fujishima

  9. Department of Hematology, Chugoku Central Hospital, 148-13 Kamiiwanari, Miyuki-cho, Fukuyama, Hiroshima, 720-0001, Japan

    Toru Kiguchi

  10. Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan

    Toshihiro Miyamoto & Koichi Akashi

  11. Department of Hematology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi, Hyogo, 673-8558, Japan

    Akio Maeda

  12. Innovative Cancer Center/Oncology-Hematology, Shimane University Hospital, 89-1 Enya, Izumo, Shimane, 693-8501, Japan

    Junji Suzumiya

  13. Department of Hematology, Osaka Saiseikai Nakatsu Hospital, 2-10-39 Shibata, Kitaku, Osaka, 530-0012, Japan

    Ryosuke Yamamura

  14. Division of Hematology and Oncology, Department of Medicine, Kurume University School of Medicine, 67 Asahicho, Kurume, Fukuoka, 830-0011, Japan

    Koji Nagafuji

  15. Department of Hematology, Yokohama Municipal Citizen’s Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8555, Japan

    Tomonori Nakazato

  16. Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8553, Japan

    Yoshiaki Kuroda

  17. Third Department of Internal Medicine, Yamaguchi University School of Medicine, 1-1-1 Minamikogushi, Ube, Yamaguchi, 755-8505, Japan

    Toshiaki Yujiri

  18. Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0006, Japan

    Yasushi Takamatsu

  19. Karatsu Higashimatsuura Medical Association, 2566-11 Chiyodacho, Karatsu, Saga, 847-0041, Japan

    Mine Harada

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  1. Kazutaka Sunami
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  2. Morio Matsumoto
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  3. Shin-ichi Fuchida
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  6. Yoko Adachi
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  9. Toru Kiguchi
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  19. Mine Harada
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  20. Koichi Akashi
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Corresponding author

Correspondence to Kazutaka Sunami.

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Conflict of interest

Kazutaka Sunami received research funding from Ono Pharmaceutical, MSD, Celgene, Abbvie, Takeda pharmaceutical, Sanofi, Bristol-Myers Squibb, Daiichi Sankyo, Janssen, Novartis, Alexion Pharma and GlaxoSmithKline, and received honoraria from Ono Pharmaceutical, Celgene, Takeda Pharmaceutical, and Bristol-Myers Squibb. Morio Matsumoto received honoraria from Janssen, Celgene and Ono Pharmaceutical. Shin-ichi Fuchida received honoraria from Takeda Pharmaceutical. Hiroyuki Takamatsu received honoraria from Janssen and Celgene. Toru Kiguchi received research funding from Daiichi Sankyo, Bristol-Myers Squibb, Otsuka Pharmaceutical, Kyowa Hakko Kirin, MSD, Astellas, Nippon Shinyaku, Novartis, Sumitomo Dainippon, Janssen, Celgene, Symbio Pharmaceutical, Taiho Pharmaceutical, Teijin, Sanofi and Celltrion. Toshihiro Miyamoto received honoraria from Celgene and MSD. Junji Suzumiya received honoraria from Eisai, Celgene, Janssen, Chugai Pharmaceutical, Abbvie and Takeda Pharmaceutical, and research funding from Chugai Pharmaceutical, Eisai, Takeda Pharmaceutical, Kyowa Hakko Kirin, Astellas, Toyama Chemical, Celgene, Celltrion and Symbio Pharmaceutical. Yasushi Takamatsu received honoraria from Ono Pharmaceutical, Kyowa Hakko Kirin and Janssen, and received from research funding from Takeda Pharmaceutical, Ono Pharmaceutical and Celgene. Koichi Akashi received honoraria from Takeda Pharmaceutical, Bristol-Myers Squibb, Novartis, Kyowa Hakko Kirin, Janssen, Pfizer, Chugai Pharmaceutical, Ono Pharmaceutical, Eisai, Astellas and Celgene, and received research funding from Taiho Pharmaceutical, Sanofi, Novartis, MSD, Astellas, Bristol-Myers Squibb, Eli Lilly, Kyowa Hakko Kirin, Chugai Pharmaceutical, Asahi Kasei, Eisai, Otsuka Pharmaceutical, Ono Pharmaceutical, Teijin, Nippon Shinyaku, Shionogi, Mitsubishi Tanabe, Sumitomo Dainippon, Toyama Chemical, Daiichi Sankyo, Takeda Pharmaceutical, Yakult, Taisho Toyama Pharmaceutical, The Chemo-Sero-Therapeutic Research Institute, Alexion Pharma and Merck Serono. The other authors have no conflict of interests to declare.

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Sunami, K., Matsumoto, M., Fuchida, Si. et al. Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma: a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12). Int J Clin Oncol 24, 966–975 (2019). https://doi.org/10.1007/s10147-019-01436-8

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