OBJECTIVES:~Determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes.~Determine whether this drug reduces the frequency of leukemia transformation and decreases bone marrow blast percentage in these patients.~Determine the effect of this drug on neutrophil and platelet production and the number of episodes of febrile neutropenia in these patients.~Determine the safety of this drug in these patients.~OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to International Prognostic Scoring System score (low and intermediate-1 vs intermediate-2 and high) and transfusion dependence (yes vs no). Patients are randomized to one of two treatment arms.~Arm I: Patients receive oral thalidomide once daily on weeks 1-24.~Arm II: Patients receive oral placebo once daily on weeks 1-24. In both arms, patients who have not progressed to leukemia after 24 weeks of therapy may receive open-label thalidomide for an additional 24 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed at 4 weeks.~PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study.
RATIONALE: Thalidomide may be an effective treatment for anemia caused by myelodysplastic syndrome.~PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating anemia in patients who have myelodysplastic syndrome.