Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome

Inclusion Criteria

• Understand and voluntarily sign an informed consent form.
• Age >/= 18 years at the time of signing the informed consent form. (Revlimid has not been tested in younger patients)
• Able to adhere to the study visit schedule and other protocol requirements.
• Diagnosis of relapsed/refractory AML (other than APL) or high-risk MDS (IPSS categories intermediate-2 and high) with chromosome 5 abnormality as a sole abnormality or with additional abnormalities. MDS patients with blast percentage of >/= 10% will be considered high-risk.
• All non-hematological toxicity of previous cancer therapy should have resolved to / = 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.

Exclusion Criteria

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Revlimid).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or experimental therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of Revlimid.
• Concurrent use of other anti-cancer agents or treatments. (Use of hydrea permitted as indicated in inclusion criterion 6)
• Known positive for HIV or infectious hepatitis type B or C.
• Heart rate less than or equal to 50.