Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study

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, 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

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.

Keywords: Dexamethasone; Japan; Japanese; lenalidomide; multiple myeloma.

© 2016 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Figures

Figure 1
Figure 1
Disposition of study patients.
Figure 2
Figure 2
Interim progression‐free survival (PFS) in the efficacy evaluable population (N = 24).

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