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| |  IMW: Thalomid Shows Clinical Benefit In Multiple Myeloma STOCKHOLM, SWEDEN -- Sept. 2, 1999 -- Researchers investigating the use of Thalomid(R) (thalidomide) to treat multiple myeloma -- one of the deadliest forms of cancer -- today reported that 30 percent of patients undergoing therapy experienced a greater than 50 percent reduction in tumour burden. It was further observed that all responders displayed some evidence of therapeutic benefit at 28 days, with continued responses occurring at four-to-six months. Data from the open-label, phase II clinical study of 20 patients with either relapsing or progressive multiple myeloma were presented by lead investigator, Brian Durie, M.D., of Cedars-Sinai Comprehensive Cancer Center, Los Angeles, at the International Myeloma Workshop (IMW), in Stockholm, Sweden. The ongoing study utilises low-dose (50 to 400 mg per day) thalidomide over eight-week trial periods. At those dosages, thalidomide was found to be generally well-tolerated with the most common side effects being somnolence, non-co-ordination, confusion, dizziness, weakness, constipation and skin rash. "This study supports prior observations of thalidomide's efficacy in multiple myeloma, but also highlights its therapeutic benefit at low, well-tolerated dosages," Dr. Durie said. "Lower doses of thalidomide mean less side effects and will allow more patients to remain on therapy longer and thus receive the full benefit of this remarkable drug." According to Dr. Durie, the findings are consistent with results of an earlier thalidomide study by Drs. Barlogie and Singhal, conducted at the Myeloma and Transplantation Research Center at the Arkansas Cancer Research Center and presented at the American Society of Hematology's 40th annual meeting in December of 1998. That study showed that 34 percent of multiple myeloma patients undergoing thalidomide therapy experienced a greater than standardised 75 percent reduction in tumour growth. Dr. Durie also presented information on how to profile multiple myeloma patients to determine which are likely or unlikely to respond to lower dose thalidomide treatment. It is expected that these patient profiles will help researchers determine ideal thalidomide dosing levels and make predictions on patient response. There are approximately 14,000 new cases of multiple myeloma diagnosed in the United States each year, making it the second most common blood cancer. Multiple myeloma is a malignant cancer of the plasma cells, which are a type of white blood cell found in many tissues of the body, but mainly in the bone marrow. As the cancer grows, it destroys normal bone tissue, causing pain and crowding out normal blood cell production. Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. The adverse drug reactions known to be associated with thalidomide treatment include: peripheral neuropathy, a common, potentially-severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with thalidomide.
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