A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q

Inclusion Criteria:

18 years or older
Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome karyotype except del 5q[31]
Anemia that requires red blood cell transfusions
Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level > 500 mU/mL
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
Must agree to follow pregnancy precautions as required by the protocol.
Must agree to receive counseling related to teratogenic and other risks of lenalidomide
Must agree not to donate blood or semen
Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study

Exclusion Criteria:

Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or deoxyribonucleic acid (DNA) modulation agents
Allergic reaction to thalidomide
Renal insufficiency creatinine clearance (CrC1)<40 mL/min by Cockcroft-Gault method)
Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed)
Absolute neutrophil count (ANC) < 500/uL
Platelets < 50,000/uL
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3X upper limit of normal
Uncontrolled hyperthyroidism or hypothyroidism
Significant neuropathy
Prior stem cell transplantation
Anemia due to reasons other than MDS
History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years
Significant active cardiac disease within the past 6 months
Known Human Immunodeficiency Virus (HIV) infection; known Hepatitis C infection or active Hepatitis B infection