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Thalidomide maintenance therapy in Japanese myeloma patients: a multicenter, phase II clinical trial (COMET study)

  • Hirokazu MurakamiEmail author
  • Tetsuhiro Kasamatsu
  • Jun Murakami
  • Toru Kiguchi
  • Takeshi Kanematsu
  • Daisuke Ogawa
  • Hiroyuki Takamatsu
  • Hiroshi Handa
  • Shuji Ozaki
  • Hirokazu Miki
  • Takeshi Takahashi
  • Takaaki Takeo
  • Tatsuya Yamauchi
  • Takanobu Morishita
  • Hiroshi Kosugi
  • Kazuyuki Shimizu
Original Article
  • 73 Downloads

Abstract

A prospective, multicenter, phase II study was performed to assess the efficacy and safety of thalidomide maintenance therapy at different doses in Japanese multiple myeloma (MM) patients. This study included 34 patients (median age, 74 years) who were previously treated with not more than three prior therapies and whose response status was evaluated as at least stable disease. They were randomized into Group A (no maintenance; 12 patients), Group B (50 mg thalidomide maintenance; 12 patients), and Group C (100 mg thalidomide maintenance; 10 patients), respectively. Thalidomide maintenance therapy resulted in improved depth of response in three cases (13.6%) and sustained response after induction therapy in eight cases (36.4%). Two-year progression-free survival (PFS) was 25.0%, 33.3%, and 77.8% in Groups A, B, and C, respectively, and was significantly higher in Group C than in Group A (p = 0.005). There was no difference in the incidence of hematological or non-hematological adverse events between Groups B and C. The current study demonstrates that maintenance with daily thalidomide at 100 mg, but not 50 mg, improved depth of response and prolonged PFS, and that this treatment was feasible for use in Japanese MM patients.

Keywords

Multiple myeloma Thalidomide Maintenance Efficacy Adverse events 

Notes

Acknowledgements

The authors would like to thank Dr. Kunihiko Hayashi of the Department of Laboratory Sciences, Gunma University Graduate School of Health Sciences, for comments on the statistical analysis. This study was supported by the Epidemiological and Clinical Research Information Network (ECRIN).

Compliance with ethical standards

Conflict of interest

Dr. Murakami H received a research grant from Fujimoto Pharmaceutical Co. Ltd. and Celgen Co. Ltd, and served on scientific advisory boards and speakers’ bureaus for Celgen Co. Ltd., Sanofi K.K., and Ono Pharmaceutical CO, Ltd. Dr. Kiguchi T received a research grant from Celgen Co. Ltd., Sanofi K.K., and Janssen Pharmaceutical K.K. Other authors have no conflict of interest.

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Copyright information

© Japanese Society of Hematology 2019

Authors and Affiliations

  • Hirokazu Murakami
    • 1
    Email author
  • Tetsuhiro Kasamatsu
    • 1
  • Jun Murakami
    • 2
  • Toru Kiguchi
    • 3
  • Takeshi Kanematsu
    • 4
  • Daisuke Ogawa
    • 5
  • Hiroyuki Takamatsu
    • 6
  • Hiroshi Handa
    • 7
  • Shuji Ozaki
    • 8
  • Hirokazu Miki
    • 9
  • Takeshi Takahashi
    • 10
  • Takaaki Takeo
    • 11
  • Tatsuya Yamauchi
    • 12
  • Takanobu Morishita
    • 13
  • Hiroshi Kosugi
    • 14
  • Kazuyuki Shimizu
    • 15
  1. 1.Department of Laboratory SciencesGunma University Graduate School of Health SciencesMaebashiJapan
  2. 2.Department of HematologyToyama University HospitalToyamaJapan
  3. 3.Department of HematologyChugoku Central HospitalFukuyamaJapan
  4. 4.Department of Clinical LaboratoryNagoya University HospitalNagoyaJapan
  5. 5.Department of HematologyNagasaki Prefectural Shimabara HospitalShimabaraJapan
  6. 6.Department of HematologyKanazawa University HospitalKanazawaJapan
  7. 7.Department of HematologyGunma UniversityMaebashiJapan
  8. 8.Department of HematologyTokushima Prefectural Central HospitalTokushimaJapan
  9. 9.Division of Transfusion Medicine and Cell TherapyTokushima University HospitalTokushimaJapan
  10. 10.Department of HematologyGifu Municipal HospitalGifuJapan
  11. 11.Department of HematologyYokkaichi Municipal HospitalYokkaichiJapan
  12. 12.Department of HematologyToki Municipal General HospitalTokiJapan
  13. 13.Department of HematologyJapanese Red Cross Nagoya Daiichi HospitalNagoyaJapan
  14. 14.Department of HematologyOgaki Municipal HospitalOgakiJapan
  15. 15.Department of Hematology/OncologyHigashi Nagoya National HospitalNagoyaJapan

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