Combination of 5-azacitidine and Lenalidomide in Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Myelodysplastic Syndromes

Inclusion Criteria:

• Understand and voluntarily sign an informed consent form.

• Age >=18 years at the time of signing the informed consent form.

• Able to adhere to the study visit schedule and other protocol requirements.

• Relapsed or refractory AML (>30% blasts, FAB classification)with karyotypeabnormalities involving monosomy 5 or del(5q) or MDS and t-MDS INT-2 or HIGH accordingto IPSS classification with karyotype abnormalities involving monosomy 5 or del(5q)either previously treated or untreated

• Not eligible for an immediate allogeneic HSCT (due to donor unavailability)

• All previous MDS or AML specific therapy with exception of corticosteroids notexceeding doses of 10mg/day prednisone must have been discontinued at least 1 weekprior to study enrollment.

• Non-hematological toxicity (except alopecia) resulting from previous treatment must beresolved to WHO CTC Grade ≤ 2.

• ECOG performance status of < 3 at study entry.

• Laboratory test results within these ranges:Serum creatinine <= 2.0 mg/dL, Totalbilirubin <= 3 x ULN, AST (SGOT) and ALT (SGPT) <= 3 x ULN

• Females of childbearing potential must agree to use a reliable form of contraceptionor to practice complete abstinence from heterosexual intercourse during the followingtime periods related to this study: 1) for at least 28 days before starting studydrug; 2) while participating in the study; and 3) for at least 28 days afterdiscontinuation from the study.

Exclusion Criteria:

• Any serious medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from signing the informed consent form.

• Pregnant or breast feeding females. (Lactating females must agree not to breast feedwhile on study).

• Any condition, including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study or confoundsthe ability to interpret data from the study.

• Known hypersensitivity to thalidomide, lenalidomide, 5-azacitidine or mannitol.

• Myocardial infarction within 6 months before study entry, New York Heart AssociationClass III or IV heart failure, uncontrolled angina or severe uncontrolled ventriculararrhythmias.

• The development of erythema nodosum if characterized by a desquamating rash whiletaking thalidomide or similar drugs.

• Uncontrolled lung disease.

• Known positive for HIV or acute infectious hepatitis, type A, B or C.

• Participation in another clinical study in the 4 weeks prior to enrollment or duringthis study.