A Phase II Study of Lenalidomide (Revlimid®) (NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy

Pts must have a morphologically confirmed diagnosis of AML per the protocol. Pts must have declined standard AML cytotoxic chemotherapy regimens. Pts must have cytogenetic evidence of the del (5q) abnormality determined either by conventional karyotyping or by FISH. Pts must have reached their 60th birthday. Pts must not have received prior systemic chemotherapy for AML with the exception of hydroxyurea. Pts must have a WBC less than or equal to 30,000/mcl within 1 day prior to registration. Pts with a history of prior myelodysplastic syndrome are eligible. Pt must have a bilirubin less than or equal to 2.5 x IULN within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction. Pts must have SGOT (AST) less than or equal to 3.5 x IULN, or SGPT (ALT) less than or equal to 3.5 x IULN, or both within 14 days prior to registration. Pts must have a serum creatinine less than or equal to 1.5 x IULN within 14 days prior to registration. Pts must be negative for HIV within 14 days prior to registration. SWOG pts must have specimens collected within 28 days prior to registration submitted to the preferred cytogenetics lab. Females of childbearing potential must have 2 negative pregnancy tests (sensitivity >/= 25 mIU/mL). Two reliable forms of contraception must be used by women of childbearing potential for at least 4 weeks before beginning therapy, during therapy, during dose interruptions and for 4 weeks following discontinuation of lenalidomide therapy. Males receiving lenalidomide must agree to use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy. Pts with a prior malignancy are eligible.