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Bortezomib maintenance therapy in transplant-ineligible myeloma patients who plateaued after bortezomib-based induction therapy: a multicenter phase II clinical trial

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Abstract

In the era of novel therapeutic agents for multiple myeloma (MM), both the significance of achieving the plateau phase and the efficacy of subsequent maintenance therapy remain unclear. In the present study, we evaluated the efficacy and safety of bortezomib maintenance therapy (biweekly for 1 year) in transplant-ineligible MM patients who plateaued after bortezomib-based induction therapy. Of 36 evaluable patients, the overall response rate during induction therapy was 61%, with a stringent complete response in 6%, a complete response in 6%, a very good partial response in 17%, and a partial response in 33%. Twenty patients achieved the plateau phase and subsequently received bortezomib maintenance therapy. Median progression-free survival from the induction and maintenance therapies was 13.8 months (95% confidence interval, 11.4–23.7 months) and 10.7 months (95% confidence interval, 3.7–10.7 months), respectively. During maintenance therapy, there were no cases with grade ≥ 2 peripheral neuropathy, nor was there any improvement in the quality of the response. In conclusion, although maintenance therapy with biweekly bortezomib for up to 1 year was feasible, plateau-oriented bortezomib induction therapy followed by bortezomib maintenance therapy was not adequate in newly diagnosed transplant-ineligible MM patients.

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Acknowledgements

We thank all of the patients who participated in this study and their families as well as all investigators, physicians, nurses, and clinical research coordinators who helped with this study.

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Authors and Affiliations

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

    Atsushi Isoda, Yuri Miyazawa & Morio Matsumoto

  2. Department of Hematology, Gunma Cancer Center, Gunma, Japan

    Kayoko Murayama

  3. Department of Medical Oncology, Iwate Medical University School of Medicine, Iwate, Japan

    Shigeki Ito

  4. Department of Hematology, Showa Inan General Hospital, Nagano, Japan

    Yoichi Kohara

  5. Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Yamanashi, Japan

    Masaki Iino

  6. Department of Medicine and Clinical Science, Gunma University Graduate School of Medicine, Gunma, Japan

    Hiroshi Handa

  7. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan

    Yosuke Imai, Takuro Ishiguro & Takaaki Chou

  8. Department of Hematology, Iwate Prefecture Ofunato Hospital, Iwate, Japan

    Wataru Izumita

  9. Department of Hematology, National Hospital Organization Matsumoto Medical Center, Nagano, Japan

    Kiyoshi Kitano & Yukio Hirabayashi

  10. Division of Hematology, Department of Internal Medicine, Shinshu University School of Medicine, Nagano, Japan

    Hideyuki Nakazawa

  11. Department of Biomedical Laboratory Medicine, Shinshu University School of Medicine, Nagano, Japan

    Fumihiro Ishida

  12. Division of Hematology and Oncology, University of Yamanashi, Yamanashi, Japan

    Toru Mitsumori & Keita Kirito

  13. Department of Laboratory Sciences, Gunma University Graduate School of Health Sciences, Gunma, Japan

    Hirokazu Murakami

Authors
  1. Atsushi Isoda
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  2. Kayoko Murayama
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  3. Shigeki Ito
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  4. Yoichi Kohara
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  5. Masaki Iino
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  6. Yuri Miyazawa
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  7. Morio Matsumoto
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  8. Hiroshi Handa
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  9. Yosuke Imai
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  10. Takuro Ishiguro
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  11. Wataru Izumita
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  12. Kiyoshi Kitano
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  13. Yukio Hirabayashi
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  14. Hideyuki Nakazawa
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  15. Fumihiro Ishida
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  16. Toru Mitsumori
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  17. Keita Kirito
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  18. Takaaki Chou
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  19. Hirokazu Murakami
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For the Kanshinetsu Multiple Myeloma Study Group

Corresponding author

Correspondence to Atsushi Isoda.

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Conflict of interest

K. Kirito received an honorarium from Novartis Pharma K.K. T. Chou received an honorarium from Takeda Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Celgene K.K., Bristol-Myers Squibb, Janssen Pharmaceutical K.K., and Novartis Pharma K.K. H. Murakami received an honorarium from Ono Pharmaceutical Co. Ltd. and Bristol-Myers Squibb.

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Isoda, A., Murayama, K., Ito, S. et al. Bortezomib maintenance therapy in transplant-ineligible myeloma patients who plateaued after bortezomib-based induction therapy: a multicenter phase II clinical trial. Int J Hematol 108, 39–46 (2018). https://doi.org/10.1007/s12185-018-2448-9

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  • DOI: https://doi.org/10.1007/s12185-018-2448-9

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