Safety and management of adverse events of ixazomib/lenalidomide/dexamethasone therapy in Japanese patients with relapsed/refractory multiple myeloma

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  • IIDA Shinsuke
    Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences
  • IZUMI Tohru
    Department of Hematology, Tochigi Cancer Center
  • AOTSUKA Nobuyuki
    Department of Hematology and Oncology, Japanese Red Cross Narita Hospital
  • KOMENO Takuya
    Department of Hematology, National Hospital Organization Mito Medical Center
  • ISHIDA Tadao
    Department of Hematology, Japanese Red Cross Medical Center
  • SUNAMI Kazutaka
    Department of Hematology, National Hospital Organization Okayama Medical Center
  • HANDA Hiroshi
    Department of Medicine and Clinical Science, Gunma University Graduate School of Medicine
  • BERG Deborah
    Millennium Pharmaceuticals Inc., a Wholly Owned Subsidiary of Takeda Pharmaceutical Company Limited
  • KASE Yoichi
    Oncology Clinical Research Department, Oncology Therapeutic Area Unit for Japan and Asia, Takeda Pharmaceutical Company Limited
  • SOEDA Junpei
    Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited

Bibliographic Information

Other Title
  • 再発・難治性多発性骨髄腫の日本人におけるixazomib/lenalidomide/dexamethasoneの安全性と有害事象の管理
  • 臨床研究 再発・難治性多発性骨髄腫の日本人におけるixazomib/lenalidomide/dexamethasoneの安全性と有害事象の管理
  • リンショウ ケンキュウ サイハツ ・ ナンチセイ タハツセイ コツズイシュ ノ ニホンジン ニ オケル ixazomib/lenalidomide/dexamethasone ノ アンゼンセイ ト ユウガイ ジショウ ノ カンリ

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Abstract

<p>Based on the outcomes of the TOURMALINE-MM1 trial—a global, randomized, double-blind, placebo-controlled phase III clinical study—the use of an oral proteasome inhibitor has been approved in combination with lenalidomide and dexamethasone (Rd) for the treatment of relapsed/refractory multiple myeloma (MM). In this study, we enrolled 41 Japanese patients, who constituted the safety population. The overall incidence of adverse events (AEs) was similar in IRd and placebo-Rd groups. AEs including thrombocytopenia, skin disorders (rash), vomiting, nausea, and diarrhea occurred more frequently in the IRd group than in the placebo-Rd group. There were no cumulative toxicities, and most toxicities were usually manageable with close monitoring, supportive care, and dose modifications. Compared with the overall safety population, the safety profile of Japanese patients was consistent. Moreover, in Japanese patients, there were no on-study deaths and the incidence of serious AEs was less frequent.</p>

Journal

  • Rinsho Ketsueki

    Rinsho Ketsueki 59 (11), 2399-2407, 2018

    The Japanese Society of Hematology

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