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-HaynesTakaaki Chou

Research output: Contribution to journalArticle

4 Citations (Scopus)

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. The FIRST trial (MM-020) demonstrated that lenalidomide plus low-dose dexamethasone (Rd) reduced risk of multiple myeloma (MM) disease progression or death; however, no Japanese patients were included in the study. MM-025 evaluated the efficacy and safety of continuous Rd treatment in 26 Japanese patients with newly diagnosed MM (NDMM). The study results support the use of continuous Rd treatment in Japanese patients with NDMM.

Original languageEnglish
Pages (from-to)653-658
Number of pages6
JournalCancer Science
Volume107
Issue number5
DOIs
Publication statusPublished - 2016 May 1

Fingerprint

Multiple Myeloma
Dexamethasone
Disease Progression
Safety
lenalidomide
Melphalan
Thalidomide
Stem Cell Transplantation
Patient Safety
Prednisone
Neutropenia
Disease-Free Survival
Anemia
Therapeutics
Kidney
Survival
Population

Keywords

  • Dexamethasone
  • Japan
  • Japanese
  • Lenalidomide
  • Multiple myeloma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Suzuki, K., Shinagawa, A., Uchida, T., Taniwaki, M., Hirata, H., Ishizawa, K., ... Chou, T. (2016). Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study. Cancer Science, 107(5), 653-658. https://doi.org/10.1111/cas.12916

Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma : A phase II study. / Suzuki, Kenshi; Shinagawa, Atsushi; Uchida, Toshiki; Taniwaki, Masafumi; Hirata, Hirokazu; Ishizawa, Kenichi; Matsue, Kosei; Ogawa, Yoshiaki; Shimizu, Takayuki; Otsuka, Maki; Matsumoto, Morio; Iida, Shinsuke; Terui, Yasuhito; Matsumura, Itaru; Ikeda, Takashi; Takezako, Naoki; Ogaki, Yumi; Midorikawa, Shuichi; Houck, Vanessa; Ervin-Haynes, Annette; Chou, Takaaki.

In: Cancer Science, Vol. 107, No. 5, 01.05.2016, p. 653-658.

Research output: Contribution to journalArticle

Suzuki, K, Shinagawa, A, Uchida, T, Taniwaki, M, Hirata, H, Ishizawa, K, Matsue, K, Ogawa, Y, Shimizu, T, Otsuka, M, Matsumoto, M, Iida, S, Terui, Y, Matsumura, I, Ikeda, T, Takezako, N, Ogaki, Y, Midorikawa, S, Houck, V, Ervin-Haynes, A & Chou, T 2016, 'Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study', Cancer Science, vol. 107, no. 5, pp. 653-658. https://doi.org/10.1111/cas.12916
Suzuki, Kenshi ; Shinagawa, Atsushi ; Uchida, Toshiki ; Taniwaki, Masafumi ; Hirata, Hirokazu ; Ishizawa, Kenichi ; Matsue, Kosei ; Ogawa, Yoshiaki ; Shimizu, Takayuki ; Otsuka, Maki ; Matsumoto, Morio ; Iida, Shinsuke ; Terui, Yasuhito ; Matsumura, Itaru ; Ikeda, Takashi ; Takezako, Naoki ; Ogaki, Yumi ; Midorikawa, Shuichi ; Houck, Vanessa ; Ervin-Haynes, Annette ; Chou, Takaaki. / Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma : A phase II study. In: Cancer Science. 2016 ; Vol. 107, No. 5. pp. 653-658.
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