Application and safety of thalidomide in the treatment of multiple myeloma

Thalidomide is now regarded as one of the most promising salvage therapies for refractory or relapsed multiple myeloma. Appropriate use of this drug is indispensable to avoid repeating drug-induced disaster. Recently, its application has been expanded from refractory or relapsed cases also to untreated patients or post transplanted cases. Thus, it should be clarified which population of the Japanese patients with myeloma may truly benefit by this drug. Guideline, recently established by the Japanese Society of Clinical Hematology, has functioned for safety use of this drug. For future approval by Japanese government, strict but well-organized system for safety applicable to the clinical setting in Japan is necessary.