A phase II study of lenalidomide consolidation and maintenance therapy after autologous PBSCT in patients with multiple myeloma

  • Shin-ichi Fuchida
  • Kazutaka Sunami
  • Morio Matsumoto
  • Hirokazu Okumura
  • Tohru Murayama
  • Toshihiro Miyamoto
  • Eichi Otsuka
  • Naohito Fujishima
  • Tohru Izumi
  • Shigehisa Tamaki
  • Yasushi Hiramatsu
  • Yoshiaki Kuroda
  • Chihiro Shimazaki
  • Koichi Akashi
  • Mine Harada
  • on behalf of the Japan Study Group for Cell Therapy and Transplantation (JSCT)
Original Article


The efficacy and safety of lenalidomide (LEN) consolidation therapy and subsequent LEN maintenance therapy after high-dose therapy with autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in patients with newly diagnosed symptomatic multiple myeloma (MM). Forty-one patients were enrolled and received high-dose dexamethasone (DEX) therapy as an initial induction. The patients who did not respond to the DEX therapy were further treated with four cycles of bortezomib plus DEX (BD) induction therapy. For patients who responded to BD, PBSC harvesting was scheduled following high-dose cyclophosphamide and filgrastim administration. After PBSC harvesting, high-dose chemotherapy of melphalan with auto-PBSCT was performed. One hundred days after auto-PBSCT, patients received consolidation therapy consisting two cycles of LEN plus low-dose DEX (Ld) and LEN maintenance therapy. Only one death occurred during mobilization therapy, but the protocol developed in this study was considered generally safe to provide. Overall response rates after consolidation and maintenance therapies were 73.7% and 81.6%, respectively. Two-year progression-free survival and overall survival were 76.3% and 92.1%, respectively. These observations suggest that LEN consolidation and maintenance therapy are effective and safe, and provide favorable response rates in patients with MM.


Lenalidomide Consolidation therapy Maintenance therapy Autologous PBSCT Multiple myeloma 



This work was supported by a grant from the Regional Medicine Research Foundation (Tochigi, Japan). We are grateful to Ms. Hiroko Watanabe (Kyusyu University) for the data analysis.

Conflict of interest

The authors have no conflict of interest.


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Copyright information

© The Japanese Society of Hematology 2018

Authors and Affiliations

  • Shin-ichi Fuchida
    • 1
  • Kazutaka Sunami
    • 2
  • Morio Matsumoto
    • 3
  • Hirokazu Okumura
    • 4
  • Tohru Murayama
    • 5
  • Toshihiro Miyamoto
    • 6
  • Eichi Otsuka
    • 7
  • Naohito Fujishima
    • 8
  • Tohru Izumi
    • 9
  • Shigehisa Tamaki
    • 10
  • Yasushi Hiramatsu
    • 11
  • Yoshiaki Kuroda
    • 12
  • Chihiro Shimazaki
    • 1
  • Koichi Akashi
    • 6
  • Mine Harada
    • 13
  • on behalf of the Japan Study Group for Cell Therapy and Transplantation (JSCT)
  1. 1.Department of HematologyJapan Community Health care Organization Kyoto Kuramaguchi Medical CenterKyotoJapan
  2. 2.National Hospital Organization Okayama Medical CenterOkayamaJapan
  3. 3.National Hospital Organization Nishigunma National HospitalShibukawaJapan
  4. 4.Toyama Prefectural Central HospitalToyamaJapan
  5. 5.Hyogo Cancer CenterAkashiJapan
  6. 6.Kyushu University HospitalFukuokaJapan
  7. 7.Oita Prefectural HospitalOitaJapan
  8. 8.Akita University HospitalAkitaJapan
  9. 9.Tochigi Cancer CenterUtsunomiyaJapan
  10. 10.Ise Red Cross HospitalIseJapan
  11. 11.Japanese Red Cross Society Himeji HospitalHimejiJapan
  12. 12.Hiroshima University HospitalHiroshimaJapan
  13. 13.Karatsu Higashimatsuura Medical AssociationKaratsuJapan

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