Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia

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 lenalidomide).
• •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 therapy within 21 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 lenalidomide except for MDS patients with del 5q31.1 abnormalities..
• •Concurrent use of other anti-cancer agents or treatments.
• •Patients may not have received prior AML induction chemotherapy or stem cell transplant. However, patients with secondary MDS who have received a stem cell transplant for other indications (eg lymphoma, multiple myeloma) will be eligible.