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| |  ASH: Thalomid Reduces Tumor Burden In Patients With Advanced Multiple Myeloma NEW ORLEANS, LA -- December 6, 1999 -- Clinical data expands upon previous published results on the use of Thalomid(R) (thalidomide) in treating advanced and refractory multiple myeloma, a malignant cancer of the plasma cells. Studies presented here at the 41st meeting of the American Society of Hematology (ASH), included use of thalidomide as a single agent and in combination with other chemotherapeutic agents.
Researchers from the Myeloma and Transplantation Research Center (MTRC) of the Arkansas Cancer Research Center (ACRC) presented results from a phase II trial of 180 patients who were treated with thalidomide. The researchers reported that 36 percent of patients achieved a greater than, or equal to, 25 percent reduction in tumor burden. Eighteen patients achieved paraprotein response of greater than, or equal to, 90 percent, 14 patients achieved a greater than, or equal to, 75 percent paraprotein response and 16 patients achieved a greater than, or equal to, 50 percent paraprotein response. Four patients achieved complete response. Paraprotein is 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. Side effects reported by the investigators were constipation, weakness/fatigue and somnolence. "These results are very encouraging," says Dr. Sol J. Barer, president and chief operating officer of Celgene Corporation. "As these and other studies are completed, Celgene is moving forward in developing this indication for submission to FDA." Patients in the study, conducted between December, 1997 and May, 1999, received an initial dose of 200 mg/day of Thalomid that was escalated every two weeks to a maximum dose of 800 mg/day. Seventy-seven percent of the patients in the study had undergone prior high dose therapy to treat their disease and 53 percent had undergone two or more cycles of such therapy. Initial results from a smaller number of patients in this study were first reported at the 1998 ASH meeting in Miami, FL and in November, 1999 in the New England Journal of Medicine. In a separate presentation, researchers from the ACRC reported on a study of 33 previously treated multiple myeloma patients who were evaluated following completion of two cycles of DT-PACE (a combination of dexamethasone at 40 mg four times a day, thalidomide at 400 mg/day, and a four-day regimen of infusions of daily doses of cisplatin, adrimycin, cyclophosphamide and etoposide). The researchers reported that after two cycles of DT-PACE, 40 percent of patients achieved a 75 percent or greater reduction in tumor mass, including 9 percent who achieved a 90 percent tumor reduction and five percent who achieved complete remission. The investigators reported that side effects associated with this regimen were neutropenic fever, DVT, and constipation and attributed the last two as probably associated with thalidomide. The Myeloma and Transplantation Research Center of the Arkansas Cancer Research Center is one of the leading myeloma and transplantation centers in the world. The ACRC is a comprehensive cancer center with multiple renowned clinical and research programs in a variety of malignancies. Both the MTRC and ACRC are entities of the University of Arkansas for Medical Sciences. There were 21 additional abstracts presented at this meeting studying thalidomide in the setting of multiple myeloma. These included a blinded analysis from a randomized study of thalidomide as part of a front line program called Total Therapy II that was conducted at the ACRC. 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 Links: Thalomid (thalidomide) and Celgene Corporation.
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