Treatment with thalidomide and dexamethasone was given to 26 patients with active, previously untreated multiple myeloma (MM). Thalidomide was administered in an initial dosage of 200 mg/d for 2 weeks and then increased as tolerated (in 200-mg increments at 2-week intervals) to a maximum daily dose of 800 mg. Dexamethasone was given orally in a dosage of 40 mg/d on days 1 through 4, 9 through 12, and 17 through 20 in odd cycles and 40 mg/d on days 1 through 4 in even cycles at monthly intervals. Response was defined as a decrease in serum and urine monoclonal (M)-protein by 50% or greater. Twenty (77%) of 26 patients with active MM exhibited a therapeutic response. Among the first seven patients treated with a thalidomide dose of 400 mg, grade III to IV skin toxicity developed in two. Drug titration was then stopped and the thalidomide dose maintained at 200 mg/d. Six (86%) of seven patients showed a response after thalidomide dose escalation, whereas 14 (74%) of 19 patients demonstrated a response with a constant thalidomide dose of 200 mg/d. Thalidomide alone produced a response in six (38%) of 16 patients with smoldering or indolent myeloma. The angiogenesis grade was elevated in only 8% of these patients. Thirty-two patients with relapsed myeloma were treated with thalidomide dosed at 200 mg/d, with 200-mg escalations every 2 weeks to a maximum daily dose of 800 mg. Prior chemotherapy had failed and five (16%) patients had experienced relapse following stem cell transplantation. Ten (38%) of the 26 patients who had received at least two cycles of therapy obtained a response.
Copyright 2001 by W.B. Saunders Company.