[Thalidomide treatment of patients with refractory myeloma in the institutes participating in the Japan Myeloma Study Group].

Thalidomide was used in 73 patients with refractory myeloma in 15 of 45 institutes participating in the Japan Myeloma Study Group. The mean age and male/female ratio were 63.8 years and 0.92 (35/38), respectively. Thirty-four patients (47%) were treated with only thalidomide, 27 patients (37%) were treated with thalidomide and steroids, and 12 (16%) were treated with thalidomide and chemotherapy. The mean initial, maximum, and maintenances dose of thalidomide were 111.0, 204.8, and 163.0 mg/day, respectively. Almost all of the patients were maintained on low-dose thalidomide between 100-200 mg/day. Complete, near complete and partial response was obtained in 31 patients (42.5%). The progression-free and overall survivals after thalidomide therapy were 9.8 and 21.3 months, respectively. The most common adverse effects were gastrointestinal disturbance, peripheral neuropathy, psychological signs, and skin eruption. In contrast to reports from Europe and America, no deep vein thrombosis was observed in this study. On the other hand, leukopenia was relatively frequently observed, and might be recognized as a serious adverse effect in myeloma patients. In conclusion, low-dose thalidomide is a useful and safe tool for the treatment of refractory myeloma.