Lenalidomide and low‐dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study |
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| Authors: | Kenshi Suzuki Atsushi Shinagawa Toshiki Uchida Masafumi Taniwaki Hirokazu Hirata Kenichi Ishizawa Kosei Matsue Yoshiaki Ogawa Takayuki Shimizu Maki Otsuka Morio Matsumoto Shinsuke Iida Yasuhito Terui Itaru Matsumura Takashi Ikeda Naoki Takezako Yumi Ogaki Shuichi Midorikawa Vanessa Houck Annette Ervin‐Haynes Takaaki Chou |
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| Affiliation: | 1. Japanese Red Cross Medical Center, Tokyo, Japan;2. Hitachi General Hospital, Hitachi, Japan;3. Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan;4. University Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan;5. Department of Hematology, Kansai Electric Power Hospital, Osaka, Japan;6. Department of Hematology and Cell Therapy, Yamagata University Faculty of Medicine, Yamagata, Japan;7. Kameda General Hospital, Kamogawa, Japan;8. Tokai University Hospital, Isehara, Japan;9. Division of Hematology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan;10. National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan;11. National Hospital Organization Nishigunma National Hospital, Shibukawa, Japan;12. Nagoya City University Hospital, Nagoya, Japan;13. The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan;14. Faculty of Medicine, Kinki University Hospital, Osakasayama, Japan;15. Shizuoka Cancer Center, Sunto, Japan;16. National Hospital Organization Disaster Medical Center, Tachikawa, Japan;17. Celgene K.K., Tokyo, Japan;18. Celgene Corporation, Summit, NJ, USA;19. Niigata Cancer Center Hospital, Niigata, Japan |
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| Abstract: | In the FIRST trial (MM‐020), lenalidomide plus low‐dose dexamethasone (Rd) reduced the risk of disease progression or death compared with combination melphalan–prednisone–thalidomide. As the FIRST trial did not include any Japanese patients, the efficacy and safety of continuous treatment with Rd was evaluated in 26 Japanese patients with newly diagnosed multiple myeloma (NDMM) in a single‐arm, multicenter, open‐label phase II trial (MM‐025). Patients received lenalidomide on days 1–21 of each 28‐day cycle, with a starting dose of 25 mg/day (dose adjusted for renal impairment), and 40 mg/day dexamethasone (dose adjusted for age) on days 1, 8, 15 and 22 of each 28‐day cycle until disease progression or discontinuation for any reason. In the efficacy evaluable population, overall response rate was 87.5%, including 29.2% of patients who achieved a complete response/very good partial response. Median durations of response, progression‐free survival and overall survival have not been reached. The most common grade 3–4 adverse events were neutropenia (23%) and anemia (19%). The efficacy and safety of Rd were consistent with data from larger studies, including the FIRST trial, thereby supporting the use of Rd continuous in Japanese patients with NDMM who are ineligible for stem cell transplantation. |
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| Keywords: | Dexamethasone Japan Japanese lenalidomide multiple myeloma |
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