- Prior history of malignancies, other than AML/myelodysplastic syndrome (MDS), unless the subject has (i) been free of the disease for ≥ 2 years. (ii) Exceptions include the following: Basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b)