Frequent good partial remissions from thalidomide including best response ever in patients with advanced refractory and relapsed myeloma

Twenty-three patients with advanced and heavily pretreated myeloma were tre ated with thalidomide. Starting dose was 200 mg/d, and 20 patients had dose escalations up to 400 (n = 5), 600 (n = 12) or 800 mg/d (n = 3), usually i n divided doses. Nineteen patients were refractory to recent chemotherapy, and four had untreated relapse after prior intensive therapy. Ten out of 23 patients (43%) achieved partial response (PR; nine with refractory and one with relapsed disease), six patients had minor response or stabilization o f the disease and four had disease progression. Another three patients died early from advanced myeloma at less than 3 weeks of thalidomide therapy Of the 10 patients with PR, seven had a better response than after any prior therapy, despite vincristine-doxorubicin-dexamethasone (VAD)-based treatmen t in all but one and high-dose melphalan with autologous stem cell support in four. Time to achieve PR was rapid in patients receiving thalidomide in divided doses (median 31 d). Responses also included reduced bone marrow pl asma cell infiltration and improved general status. Normalized polyclonal g ammaglobulin levels were seen in four cases. Six out of 10 patients with PR remained in remission with a median time on treatment of 23 weeks (range 1 5-50 weeks). Sedation was common but usually tolerable, and some patients c ontinued full- or part-time work. Four patients had skin problems, three pa tients had pneumonia, one hypothyrosis, one sinus bradycardia and one minor sensory neuropathy Thalidomide may induce good partial remissions in advan ced refractory myeloma with tolerable toxicity, and should be evaluated in other settings for myeloma patients. Divided thalidomide doses seem to redu ce time to achieve remission and may improve response rate.