title: Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma.
abstract: We conducted a multicenter, open-label study to investigate the safety, efficacy, and pharmacokinetics of lenalidomide in Japanese patients with relapsed or refractory multiple myeloma The study was composed of the "monotherapy phase", a dose-escalation phase, to determine the tolerability to single agent lenalidomide and the "combination phase" to determine the safety and obtain preliminary data on the efficacy of lenalidomide plus dexamethasone. The primary end points were the tolerability to 25 mg lenalidomide and safety. Nine and six patients were enrolled in the monotherapy phase and the combination phase, respectively. Since 25 mg of monotherapy treatment did not satisfy the DLT criteria, this dose was employed in the combination phase. The major adverse event was myelosuppression. At the planned interim analysis (median study duration, 26.3 weeks), grade 3 or grade 4 neutropenia was observed with high frequency (66.7%). However, all adverse events observed were clinically manageable. In the combination cohort, the overall response rate (> or =PR) was 100%. The pharmacokinetics of lenalidomide showed rapid absorption and elimination after both single and multiple doses. In conclusion, 25 mg of lenalidomide was given safely as a single agent or in combination with dexamethasone in Japanese patients. The good efficacy of the combination therapy was also demonstrated in this study.
authors.affiliation: Department of Medical Oncology and Immunology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan. iida@med.nagoya-cu.ac.jp
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Iida
authors.forename: Takaaki
authors.initials: T
authors.lastname: Chou
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Okamoto
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Nagai
authors.forename: Kiyohiko
authors.initials: K
authors.lastname: Hatake
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Murakami
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Takagi
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimizu
authors.forename: Henry
authors.initials: H
authors.lastname: Lau
authors.forename: Kenichi
authors.initials: K
authors.lastname: Takeshita
authors.forename: Masaaki
authors.initials: M
authors.lastname: Takatoku
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D003907:Dexamethasone / Q000008:administration & dosage*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy*; D016879:Salvage Therapy / Q000379:methods; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide