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| |  Thalidomid Shows Promise Against Multiple Myeloma In Relapsing Patients WARREN, NJ -- November 18, 1999 -- Clinical research published today in the current edition of the New England Journal of Medicine reports results of a study on the use of Thalomid ® (thalidomide) in multiple myeloma patients who have relapsed after high-dose chemotherapy. The phase II study, conducted at the University of Arkansas Cancer Research Center (ACRC), found that 32 percent (27) of patients had a partial response and ten percent (eight) of patients had complete or nearly complete remission. An editorial authored by Drs. Noopur Raje, and Kenneth Anderson, Dana-Farber Cancer Institute, accompanied the study in the New England Journal of Medicine.
Seventy-eight percent of responders had evidence of response within two months of thalidomide treatment with all but two showing response within four months. Prior to the study, 76 of the 84 study participants had disease relapse following high-dose chemotherapy, and all 84 had progressive disease including an increase in paraprotein levels greater than 25 percent. "These findings help define an evolving role for thalidomide as a potential therapy for multiple myeloma patients," said Dr. Bart Barlogie, director of the Arkansas Cancer Research Center. "We are continuing the evaluation of Thalidomid e in multiple myeloma in a variety of additional protocols at various disease stages and in combination with conventional chemotherapy." The responses cited in the study's data were assessed on the basis of a reduction of paraprotein; the myeloma protein in serum or Bence Jones protein in urine. To be considered a response, these paraprotein reductions must have been observed on two occasions at least six weeks apart. At the end of twelve months of follow-up, 22 percent of the patients remained event-free and According to Dr. Barlogie, most of the patients' reductions in paraprotein were accompanied by additional antitumor activity. A reduction in the percentage of plasma cells in bone marrow and an increase in hemoglobin levels occurred in the majority of patients. The trial's most commonly reported adverse effects were constipation, weakness or fatigue, neuropathy and somnolence. In most cases these effects were alleviated when doses of thalidomide were reduced. "We are pleased that the first peer-reviewed manuscript, involving the evaluation of the safety and efficacy of Thalomid in the treatment of multiple myeloma was published in the New England Journal of Medicine," said Dr. Sol Barer, president and chief operating officer of Celgene. "We look forward to reports of further results of this on-going experience of what is now 180 patients at the ACRC. We are also pleased that the ACRC, under Dr. Barlogie's leadership, has embarked on a series of additional investigations to explore the potential role of Thalomid in combination with other agents known to have activity in multiple myeloma." 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. Incurable with conventional chemotherapy, 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. To minimize this risk, only prescribers and pharmacies registered with the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) distribution program may prescribe or dispense Thalomid (thalidomide). Other adverse drug reactions known to be associated with thalidomide therapy include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; hypersensitivity reactions and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with Thalomid . Thalomid (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of cutaneous manifestation recurrences. Thalomid is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Related Link: Thalomid ® (thalidomide), Celgene Corporation and New England Journal of Medicine.
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