title: A noninterventional observational registry of patients with multiple myeloma treated with lenalidomide in Taiwan.
abstract: OBJECTIVE
  The incidence of multiple myeloma in Asia has risen in the past 30 years. Lenalidomide, an IMiD immunomodulatory agent, has improved the overall survival in patients with relapsed/refractory multiple myeloma (RRMM) when used with dexamethasone versus dexamethasone alone. This observational registry (T-CC-MM-009; NCT01752075) assessed the safety and efficacy of lenalidomide plus dexamethasone in a large Chinese population of patients with RRMM.
  
  
  METHODS
  This registry followed the first 100 patients treated with lenalidomide plus dexamethasone in Taiwan. Patients were ≥18 years old and had ≥1 prior treatment. The recommended starting dose for the first four 28-day cycles was 25 mg lenalidomide on days 1-21 and 40 mg dexamethasone on days 1-4, 9-12, and 17-20. Thereafter, dexamethasone was given on days 1-4 only. The primary objective was safety; secondary objectives were efficacy, lenalidomide dosage, and reasons for discontinuation.
  
  
  RESULTS
  The median duration of treatment was 34.6 weeks, and 75.5% completed ≥3 cycles. Most patients (82.7%) experienced ≥1 treatment-related adverse event; the most commonly reported were neutropenia (23.5%), thrombocytopenia (19.4%), anemia (16.3%), fatigue (16.3%), and hypoesthesia (15.3%). Bleeding events (25.5% of patients) were mostly grade 1/2 (80%). Three patients (3%) had venous thromboembolic events. Two invasive second primary malignancies were reported; however, time to onset was <1 year, suggesting they may not be related to lenalidomide. The overall response rate was 34.7%; median time to disease progression was 20.5 months.
  
  
  CONCLUSIONS
  These data confirm the safety and efficacy of lenalidomide plus dexamethasone for patients with RRMM in Taiwan.
authors.affiliation: Hematology Department, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: syhuang55@ntuh.gov.tw.
authors.forename: Shang-Yi
authors.initials: SY
authors.lastname: Huang
authors.affiliation: Hematology Department, Taipei Veterans General Hospital, Beitou District, Taipei City, Taiwan.
authors.forename: Yuan-Bin
authors.initials: YB
authors.lastname: Yu
authors.affiliation: Hematology Department, China Medical University Hospital, Taichung City, Taiwan.
authors.forename: Su-Peng
authors.initials: SP
authors.lastname: Yeh
authors.affiliation: Hematology Department, National Cheng Kung University Hospital, Tainan, Taiwan.
authors.forename: Tsai-Yun
authors.initials: TY
authors.lastname: Chen
authors.affiliation: Hematology Department, Tri Service General Hospital, Neihu District, Taipei City, Taiwan.
authors.forename: Woei-Yau
authors.initials: WY
authors.lastname: Kao
authors.affiliation: Hematology Department, Chang Gung Memorial Hospital, Chiayi, and Chang Gung University, Puzi City, Chiayi County, Taiwan.
authors.forename: Chih-Cheng
authors.initials: CC
authors.lastname: Chen
authors.affiliation: Hematology Department, Chang Gung Memorial Hospital, Kaohsiung, Kaohsiung County, Taiwan.
authors.forename: Ming-Chung
authors.initials: MC
authors.lastname: Wang
authors.affiliation: Hematology Department, Changhua Christian Hospital, Changhua, Taiwan.
authors.forename: Hsuan-Yu
authors.initials: HY
authors.lastname: Lin
authors.affiliation: Hematology Department, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors.forename: Sheng-Fung
authors.initials: SF
authors.lastname: Lin
authors.affiliation: Hematology Department, Taichung Veterans General Hospital, Taichung, Taiwan.
authors.forename: Tseng-Hsi
authors.initials: TH
authors.lastname: Lin
authors.affiliation: Hematology Department, Celgene Corporation, Summit, NJ, USA.
authors.forename: Ye
authors.initials: Y
authors.lastname: Hua
authors.affiliation: Hematology Department, Celgene Corporation, Summit, NJ, USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Puccio-Pick
authors.affiliation: Hematology Department, Celgene Corporation, Summit, NJ, USA.
authors.forename: Dena
authors.initials: D
authors.lastname: DeMarco
authors.affiliation: Hematology Department, Celgene Corporation, Summit, NJ, USA.
authors.forename: Christian
authors.initials: C
authors.lastname: Jacques
authors.affiliation: Hematology Department, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan County, Taiwan.
authors.forename: Po
authors.initials: P
authors.lastname: Dunn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D012042:Registries; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D013792:Thalidomide; D000077269:Lenalidomide
keywords: dexamethasone; lenalidomide; multiple myeloma; registry