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International Journal of Hematology

, Volume 107, Issue 5, pp 541–550 | Cite as

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

  • Yayoi Matsumura-Kimoto
  • Junya Kuroda
  • Hitomi Kaneko
  • Yuri Kamitsuji
  • Shin-ichi Fuchida
  • Aya Nakaya
  • Hirohiko Shibayama
  • Nobuhiko Uoshima
  • Isao Yokota
  • Hitoji Uchiyama
  • Hideo Yagi
  • Satoru Kosugi
  • Toshimitsu Matsui
  • Jun Ishikawa
  • Mitsuhiro Matsuda
  • Kensuke Ohta
  • Masato Iida
  • Hirokazu Tanaka
  • Masayuki Kobayashi
  • Katsuya Wada
  • Chihiro Shimazaki
  • Shosaku Nomura
  • Kazunori Imada
  • Masayuki Hino
  • Itaru Matsumura
  • Yuzuru Kanakura
  • Akifumi Takaori-Kondo
  • Kansai Myeloma Forum Investigators
Original Article
  • 834 Downloads

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.

Keywords

Multiple myeloma Pomalidomide Efficacy Adverse events 

Notes

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 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.

Compliance with ethical standards

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.

Supplementary material

12185_2018_2416_MOESM1_ESM.docx (15 kb)
Supplementary material 1 (DOCX 15 kb)

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Copyright information

© The Japanese Society of Hematology 2018

Authors and Affiliations

  • Yayoi Matsumura-Kimoto
    • 1
  • Junya Kuroda
    • 1
  • Hitomi Kaneko
    • 2
  • Yuri Kamitsuji
    • 3
  • Shin-ichi Fuchida
    • 4
  • Aya Nakaya
    • 5
  • Hirohiko Shibayama
    • 6
  • Nobuhiko Uoshima
    • 7
  • Isao Yokota
    • 8
  • Hitoji Uchiyama
    • 9
  • Hideo Yagi
    • 10
  • Satoru Kosugi
    • 11
  • Toshimitsu Matsui
    • 12
  • Jun Ishikawa
    • 13
  • Mitsuhiro Matsuda
    • 14
  • Kensuke Ohta
    • 15
  • Masato Iida
    • 16
  • Hirokazu Tanaka
    • 17
  • Masayuki Kobayashi
    • 18
  • Katsuya Wada
    • 3
  • Chihiro Shimazaki
    • 4
  • Shosaku Nomura
    • 5
  • Kazunori Imada
    • 2
  • Masayuki Hino
    • 19
  • Itaru Matsumura
    • 17
  • Yuzuru Kanakura
    • 6
  • Akifumi Takaori-Kondo
    • 18
  • Kansai Myeloma Forum Investigators
  1. 1.Division of Hematology and Oncology, Department of MedicineKyoto Prefectural University of MedicineKyotoJapan
  2. 2.Department of HematologyJapanese Red Cross Osaka HospitalOsakaJapan
  3. 3.Department of HematologyMatsushita Memorial HospitalOsakaJapan
  4. 4.Department of HematologyJapan Community Health Care Organization Kyoto Kuramaguchi Medical CenterKyotoJapan
  5. 5.First Department of Internal MedicineKansai Medical UniversityOsakaJapan
  6. 6.Department of Hematology and OncologyOsaka University Graduate School of MedicineOsakaJapan
  7. 7.Department of HematologyJapanese Red Cross Kyoto Daini HospitalKyotoJapan
  8. 8.Department of Biostatistics, Graduate School of Medical ScienceKyoto Prefectural University of MedicineKyotoJapan
  9. 9.Department of HematologyJapanese Red Cross Kyoto Daiichi HospitalKyotoJapan
  10. 10.Division of Hematology, Nara HospitalKinki University School of MedicineNaraJapan
  11. 11.Department of HematologyToyonaka Municipal HospitalOsakaJapan
  12. 12.Department of HematologyNishiwaki Municipal HospitalHyogoJapan
  13. 13.Department of Hematology and OncologyOsaka Medical Center for Cancer and Cardiovascular DiseaseOsakaJapan
  14. 14.Department of HematologyPL General HospitalOsakaJapan
  15. 15.Department of HematologyOsaka Saiseikai Nakatsu HospitalOsakaJapan
  16. 16.Department of Hematology and OncologyKawasaki HospitalHyogoJapan
  17. 17.Division of Hematology and Rheumatology, Department of Internal Medicine, Faculty of MedicineKinki UniversityOsakaJapan
  18. 18.Department of Hematology and OncologyKyoto UniversityKyotoJapan
  19. 19.Department of Hematology, Graduate School of MedicineOsaka City UniversityOsakaJapan

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