|Inclusion Criteria:||1) Patients with higher risk MDS (bone marrow blasts >/= 10% to 30% inclusive) of any age who refuse or are not eligible for frontline chemotherapy.|
2) No prior therapy for higher risk MDS as defined above.
3) Performance status of </= 2 by the ECOG scale.
4) Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UTMDACC.
5) Hydroxyurea for patients with rapidly proliferative disease can be used up to 24 hours prior to therapy but not concomitantly with 5-azacitidine or lenalidomide. Hydroxyurea can be used once the patient has completed the planned 5 axacitidine and lenalidomide treatment.
6) Adequate liver function (bilirubin of </= 2mg/dL, SGPT </= 2.5 x ULN or 5 x ULN if related to leukemia tissue infiltration)
7) Renal function - creatinine </= 2mg/dL, patients with CrCl < 30ml/min are excluded.
8) All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
9) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
10) Continued from #9: Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.