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.
PURPOSE: We report the use of thalidomide to treat multiple myeloma, and 
describe problems arising in the Thaled® outpatient department.
PATIENTS AND METHODS: Multiple myeloma patients treated with thalidomide at 
Hitachi General Hospital.
INTERVENTION: 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.
CONCLUSION: 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.