A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND STUDY TO COMPARE THE EFFICACY AND SAFETY OF ORAL AZACITIDINE PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN SUBJECTS WITH RED BLOOD CELL TRANSFUSION-DEPENDENT ANEMIA AND THROMBOCYTOPENIA DUE TO IPSS LOWER-RISK MYELODYSPLASTIC SYNDROMES
The goal of this clinical research study is to learn if patients with myelodysplastic syndrome (MDS) need fewer blood transfusions if they take azacitidine given by mouth (CC-486), compared to a placebo. The safety of the study drug will also be studied. Azacitidine is designed to block proteins in cancer cells that stop the function of tumor-fighting genes. When the drug blocks the "bad" proteins, the tumor-fighting proteins may be able to work better. A placebo is not a drug. It looks like the study drug, but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Treatment Location: N/A
IRB Review and Approval Date: 02/27/2013
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
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