Clinical Trials Resource Center

Collagen Vascular Diseases

December 16, 2002

Celgene reported positive results from a phase II trial investigating Thalomid (thalidomide) in combination with prednisone for the treatment of myelofibrosis. The data demonstrated that 13 of 21 subjects (62%) achieved an objective clinical response that was defined by an increase in red blood cells or platelets. Seven of ten subjects (70%) who were red cell transfusion dependent responded to the combination therapy and four of the ten subjects (40%) became transfusion independent. Six of eight subjects (75%) with thrombocytopenia experienced a more than 50% increase in their platelet count. The most commonly reported adverse events were constipation, leukocytosis, mild neuropathy and mild sedation. The study enrolled 21 subjects with myelofibrosis who received 50 mg/day of Thalomid and a tapering regimen of prednisone.

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