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| |  DG DISPATCH - ASH: Thalidomide Plus Dexamethasone Has Potential As First-Line Therapy For Multiple Myeloma By Jill Stein Special to DG News SAN FRANCISCO, CA -- December 4, 2000 -- The combination of thalidomide and dexomethasone is a promising treatment for patients with newly diagnosed multiple myeloma, according to data from a phase II trial presented at the 42nd Annual Meeting of the American Society of Hematology (ASH). The results show that approximately three-quarters of patients responded to the combination, said S. Vincent Rajkumar, MD, with the Mayo Clinic in Rochester, Minnesota. In this study, a response was defined as a decrease in serum and urine monoclonal protein of at least 50 percent. Prior research has shown that the combination of thalidomide and dexomethasone is effective in patients with multiple myleloma who have relapsed after conventional treatment. For the trial, 26 patients with newly-diagnosed, active multiple myeloma received oral thalidomide 200 mg daily and oral dexamethasone 40 mg daily on days 1-4, 9-12 and 17-20 on odd cycles and 40 mg daily on days 1-4 on even cycles. This regimen was repeated monthly. The initial protocol called for dose escalation of thalidomide up to 800 mg. However, due to grade 3 to 4 skin toxicity in two of the first seven patients, the protocol was amended to stop dose escalation. The thalidomide dose was kept constant at 200 mg for the next 19 patients. A confirmed response was seen in 20 patients or 77 percent. The response rate was 86 percent with thalidomide dose escalation in six of seven patients and 74 percent when the thalidomide dose remained constant at 200 mg in 14 of 19 patients. The trial included an additional 16 patients with smoldering/indolent myeloma who were treated with thalidomide alone. These patients received thalidomide 100 mg daily for two weeks, which was then increased as tolerated by 200 mg daily for two weeks to a maximum dose of 800 mg daily. In this cohort, confirmed responses were seen in six (38 percent) patients. If minor responses are included in the analysis, the response rate increases to 69 percent (11 of 16 patients). The researchers emphasized that the results are preliminary and added that the response rates and toxicities are still being evaluated.
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