title: Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study.
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.
authors.affiliation: Japanese Red Cross Medical Center, Tokyo, Japan.
authors.forename: Kenshi
authors.initials: K
authors.lastname: Suzuki
authors.affiliation: Hitachi General Hospital, Hitachi, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Shinagawa
authors.affiliation: Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
authors.forename: Toshiki
authors.initials: T
authors.lastname: Uchida
authors.affiliation: University Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Taniwaki
authors.affiliation: Department of Hematology, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Hirata
authors.affiliation: Department of Hematology and Cell Therapy, Yamagata University Faculty of Medicine, Yamagata, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Ishizawa
authors.affiliation: Kameda General Hospital, Kamogawa, Japan.
authors.forename: Kosei
authors.initials: K
authors.lastname: Matsue
authors.affiliation: Tokai University Hospital, Isehara, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Ogawa
authors.affiliation: Division of Hematology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Shimizu
authors.affiliation: National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan.
authors.forename: Maki
authors.initials: M
authors.lastname: Otsuka
authors.affiliation: National Hospital Organization Nishigunma National Hospital, Shibukawa, Japan.
authors.forename: Morio
authors.initials: M
authors.lastname: Matsumoto
authors.affiliation: Nagoya City University Hospital, Nagoya, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Iida
authors.affiliation: The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Terui
authors.affiliation: Faculty of Medicine, Kinki University Hospital, Osakasayama, Japan.
authors.forename: Itaru
authors.initials: I
authors.lastname: Matsumura
authors.affiliation: Shizuoka Cancer Center, Sunto, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ikeda
authors.affiliation: National Hospital Organization Disaster Medical Center, Tachikawa, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Takezako
authors.affiliation: Celgene K.K., Tokyo, Japan.
authors.forename: Yumi
authors.initials: Y
authors.lastname: Ogaki
authors.affiliation: Celgene K.K., Tokyo, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Midorikawa
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Houck
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Annette
authors.initials: A
authors.lastname: Ervin-Haynes
authors.affiliation: Niigata Cancer Center Hospital, Niigata, Japan.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Chou
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy*; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide
keywords: Dexamethasone; Japan; Japanese; lenalidomide; multiple myeloma