RESUMO
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.