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Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma

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An Erratum to this article was published on 01 July 2010

Abstract

We conducted a multicenter, open-label study to investigate the safety, efficacy, and pharmacokinetics of lenalidomide in Japanese patients with relapsed or refractory multiple myeloma The study was composed of the “monotherapy phase”, a dose-escalation phase, to determine the tolerability to single agent lenalidomide and the “combination phase” to determine the safety and obtain preliminary data on the efficacy of lenalidomide plus dexamethasone. The primary end points were the tolerability to 25 mg lenalidomide and safety. Nine and six patients were enrolled in the monotherapy phase and the combination phase, respectively. Since 25 mg of monotherapy treatment did not satisfy the DLT criteria, this dose was employed in the combination phase. The major adverse event was myelosuppression. At the planned interim analysis (median study duration, 26.3 weeks), grade 3 or grade 4 neutropenia was observed with high frequency (66.7%). However, all adverse events observed were clinically manageable. In the combination cohort, the overall response rate (≥PR) was 100%. The pharmacokinetics of lenalidomide showed rapid absorption and elimination after both single and multiple doses. In conclusion, 25 mg of lenalidomide was given safely as a single agent or in combination with dexamethasone in Japanese patients. The good efficacy of the combination therapy was also demonstrated in this study.

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Conflict of interest statement

Conflicts of interest of all authors are as follows; H. Lau, K. Takeshita, and M. Takatoku are employees of Celgene Co., Ltd. S. Iida, T. Chou, S. Okamoto, H. Nagai, K. Hatake, H. Murakami, T. Takagi, K. Shimizu, and T. Hotta received acceptance research expenses for this trial from Celgene KK, Tokyo. S. Iida received research grants from Kyowa Hakko Kirin Co., Ltd. and Chugai Pharmaceutical Co., Ltd. H. Murakami received grants from Janssen Pharmaceutical K.K. and Novartis Pharma K.K. S. Iida declares honoraria from Janssen Pharmaceutical K.K.

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Authors and Affiliations

  1. Department of Medical Oncology and Immunology, Nagoya City University Graduate School of Medical Sciences, 1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan

    Shinsuke Iida

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

    Takaaki Chou

  3. Division of Hematology, Keio University School of Medicine, Tokyo, Japan

    Shinichiro Okamoto

  4. National Hospital Organization Nagoya Medical Center, Nagoya, Japan

    Hirokazu Nagai & Tomomitsu Hotta

  5. Cancer Institute Hospital, Tokyo, Japan

    Kiyohiko Hatake

  6. School of Health Sciences, Faculty of Medicine, Gunma University, Maebashi, Japan

    Hirokazu Murakami

  7. Kimitsu Chuo Hospital, Kisarazu, Japan

    Toshiyuki Takagi

  8. Nagoya City Midori General Hospital, Nagoya, Japan

    Kazuyuki Shimizu

  9. Celgene Corporation, Summit, USA

    Henry Lau & Kenichi Takeshita

  10. Celgene KK, Tokyo, Japan

    Kenichi Takeshita & Masaaki Takatoku

Authors
  1. Shinsuke Iida
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  2. Takaaki Chou
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  3. Shinichiro Okamoto
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  4. Hirokazu Nagai
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  5. Kiyohiko Hatake
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  6. Hirokazu Murakami
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  7. Toshiyuki Takagi
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  8. Kazuyuki Shimizu
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  9. Henry Lau
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  10. Kenichi Takeshita
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  11. Masaaki Takatoku
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  12. Tomomitsu Hotta
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Corresponding author

Correspondence to Shinsuke Iida.

Additional information

An erratum to this article can be found at http://dx.doi.org/10.1007/s12185-010-0634-5

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Iida, S., Chou, T., Okamoto, S. et al. Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol 92, 118–126 (2010). https://doi.org/10.1007/s12185-010-0624-7

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  • DOI: https://doi.org/10.1007/s12185-010-0624-7

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