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Pomalidomide with or without dexamethasone for relapsed/refractory multiple myeloma in Japan: a retrospective analysis by the Kansai Myeloma Forum

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Abstract

Determinants of the efficacy and safety of pomalidomide (POM) monotherapy or POM plus dexamethasone (DEX) (POM/DEX) for relapsed and refractory multiple myeloma (RRMM) were examined retrospectively in a real-world clinical practice setting in Japan. The subjects were 108 patients registered with the Kansai Myeloma Forum, who were treated with either POM or POM/DEX. Of these, 79 (73%), 73 (68%), and 58 (54%) were resistant to bortezomib (BTZ), lenalidomide (LEN), and both BTZ and LEN, respectively. The median overall survival (OS) was not reached. The median time to treatment failure (TTF) was 4.4 months. The best response was recorded in 96 patients, with a 31% overall response rate (ORR) and a 79% rate of achieving at least stable disease. Number of pre-POM regimens ≥ 5, non-IgG-type M-protein, and time from initial therapy to POM or POM/DEX therapy < 2 years were associated with shorter TTF and OS. Frequent (> 10%) severe adverse events included neutropenia (55.1%), thrombocytopenia (33.7%), anemia (30.6%), febrile neutropenia (12.2%), fatigue (11.2%), and anorexia (10.2%). In conclusion, POM and POM/DEX showed substantial efficacy against RRMM, but new combination therapies with POM are needed to improve efficacy further without causing hematologic toxicities.

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Acknowledgements

We wish to thank all myeloma patients registered in KMF and all KMF investigators for their scientific support. We also thank Ms. Okuyama R for her assistance to this study.

Author information

Authors and Affiliations

  1. Division of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566, Japan

    Yayoi Matsumura-Kimoto & Junya Kuroda

  2. Department of Hematology, Japanese Red Cross Osaka Hospital, Osaka, Japan

    Hitomi Kaneko & Kazunori Imada

  3. Department of Hematology, Matsushita Memorial Hospital, Osaka, Japan

    Yuri Kamitsuji & Katsuya Wada

  4. Department of Hematology, Japan Community Health Care Organization Kyoto Kuramaguchi Medical Center, Kyoto, Japan

    Shin-ichi Fuchida & Chihiro Shimazaki

  5. First Department of Internal Medicine, Kansai Medical University, Osaka, Japan

    Aya Nakaya & Shosaku Nomura

  6. Department of Hematology and Oncology, Osaka University Graduate School of Medicine, Osaka, Japan

    Hirohiko Shibayama & Yuzuru Kanakura

  7. Department of Hematology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan

    Nobuhiko Uoshima

  8. Department of Biostatistics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan

    Isao Yokota

  9. Department of Hematology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan

    Hitoji Uchiyama

  10. Division of Hematology, Nara Hospital, Kinki University School of Medicine, Nara, Japan

    Hideo Yagi

  11. Department of Hematology, Toyonaka Municipal Hospital, Osaka, Japan

    Satoru Kosugi

  12. Department of Hematology, Nishiwaki Municipal Hospital, Hyogo, Japan

    Toshimitsu Matsui

  13. Department of Hematology and Oncology, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka, Japan

    Jun Ishikawa

  14. Department of Hematology, PL General Hospital, Osaka, Japan

    Mitsuhiro Matsuda

  15. Department of Hematology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan

    Kensuke Ohta

  16. Department of Hematology and Oncology, Kawasaki Hospital, Hyogo, Japan

    Masato Iida

  17. Division of Hematology and Rheumatology, Department of Internal Medicine, Faculty of Medicine, Kinki University, Osaka, Japan

    Hirokazu Tanaka & Itaru Matsumura

  18. Department of Hematology and Oncology, Kyoto University, Kyoto, Japan

    Masayuki Kobayashi & Akifumi Takaori-Kondo

  19. Department of Hematology, Graduate School of Medicine, Osaka City University, Osaka, Japan

    Masayuki Hino

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  1. Yayoi Matsumura-Kimoto
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Kansai Myeloma Forum Investigators

Contributions

Author contributions

YMK and JK designed the study. YMK and IY performed the statistical analysis. HK, YK, SF, AN, HS, NU, HU, HY, SK, TM, JI, MM, KO, MI, HK, MK, KW, CS, SN, KI, MH, IM, YK, and ATK provided patient data.

Corresponding author

Correspondence to Junya Kuroda.

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Conflict of interest

This work was supported by grants from Celgene Co., Ltd., Takeda Pharmaceutical Co., Ltd., Fujimoto Pharmaceutical Co., Ltd., and Ono Pharmaceutical Co., Ltd.

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Matsumura-Kimoto, Y., Kuroda, J., Kaneko, H. et al. Pomalidomide with or without dexamethasone for relapsed/refractory multiple myeloma in Japan: a retrospective analysis by the Kansai Myeloma Forum. Int J Hematol 107, 541–550 (2018). https://doi.org/10.1007/s12185-018-2416-4

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  • DOI: https://doi.org/10.1007/s12185-018-2416-4

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