title: [Reported use of thalidomide in multiple myeloma: presentation of problems in the Thaled® outpatient department].
abstract: BACKGROUND
  Thalidomide was approved in Japan for multiple myeloma treatment in October 2008. A program called the Thalidomide Education and Risk Management System (TERMS®) was established to help ensure that every effort is made to use the drug safely.
  
  
  OBJECTIVE
  We report the use of thalidomide to treat multiple myeloma, and describe problems arising in the Thaled® outpatient department.
  
  
  METHODS
  Multiple myeloma patients treated with thalidomide at Hitachi General Hospital.
  
  
  METHODS
  Monitoring of the efficacy and safety of thalidomide, and a questionnaire survey conducted at the Thaled® outpatient department.
  
  
  RESULTS
  The thalidomide response rate was 41. 7%. In 5 cases, all patients received steroids along with thalidomide. After auto-PBSCT, 1 of 2 cases demonstrated a good response (PR 1). After treatment with bortezomib, 1 of 2 cases demonstrated a good response (MR 1). After auto-PBSCT and treatment with bortezomib, 1 of 4 cases demonstrated a good response (PR 1). In a case demonstrating hematotoxicity Grade 3 (in addition to neutropenia), administration was discontinued. Regarding problems in the Thaled® outpatient department, the medical staff indicated that TERMS® is a very complicated program, while the patients requested prolongation of the prescription days and reduction of the economic burden of medication costs.
  
  
  CONCLUSIONS
  Thalidomide showed some success in treating multiple myeloma either after auto-PBSCT or following treatment with bortezomib. In the case demonstrating hematotoxicity Grade 3 (in addition to neutropenia), grave complications could have very easily developed, thus underscoring the importance of careful monitoring. Based on a questionnaire survey conducted in the Thaled® outpatient department, the medical staff made comments and patients raised issues that should be examined in the future.
authors.affiliation: Dept. of Pharmacy, Hitachi General Hospital.
authors.forename: Yuka
authors.initials: Y
authors.lastname: Aimono
authors.forename: Wataru
authors.initials: W
authors.lastname: Sato
authors.forename: Eriko
authors.initials: E
authors.lastname: Otani
authors.forename: Saori
authors.initials: S
authors.lastname: Isa
authors.forename: Takayuki
authors.initials: T
authors.lastname: Sawahata
authors.forename: Masashi
authors.initials: M
authors.lastname: Onozaki
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Saito
authors.forename: Sanae
authors.initials: S
authors.lastname: Ebata
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Aoyama
authors.forename: Miwako
authors.initials: M
authors.lastname: Hakozaki
authors.forename: Mitsuko
authors.initials: M
authors.lastname: Suzuki
authors.forename: Daisuke
authors.initials: D
authors.lastname: Kudo
authors.forename: Yuriko
authors.initials: Y
authors.lastname: Monma
authors.forename: Norio
authors.initials: N
authors.lastname: Chikatsu
authors.forename: Atsushi
authors.initials: A
authors.lastname: Shinagawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000554:Ambulatory Care Facilities; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D020533:Angiogenesis Inhibitors; D013792:Thalidomide