Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome

Revlimid is designed to change the body's immune system. It may also interfere with the
development of tiny blood vessels that help support tumor growth. It is possible that it
may help reduce or prevent the growth of cancer cells.

Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will be
asked questions about your medical history, including information about any other illnesses
you may currently have. You will have your past and current cancer status and cancer
symptoms reviewed. The study doctor will also review any treatment, including transfusions,
that you received for your disease. You will be asked about any medications you may have
been taking in the 4 weeks before starting this study. You will have a complete physical
exam, including measurement of your vital signs (blood pressure, heart rate, temperature,
and breathing rate). You will have blood drawn (about 3 tablespoons) to test for blood
counts and chemistries within 7 days before the start of this study. You will have an
electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You
will have an ECG at different times during this study, whenever the study doctor thinks it
is necessary.

Women who are able to have children must have a negative urine or blood (less than 1
teaspoon) pregnancy test 10 -14 days and 24 hours before starting Revlimid therapy, even if
they have not had a menstrual period due to treatment of the disease or had as little as one
menstrual period in the past 24 months. If you have regular or no menstrual cycles, you
will then have pregnancy tests every week for the first 4 weeks, then every 4 weeks while
taking Revlimid, again when you have been taken off of Revlimid therapy, and then 28 days
after you have stopped taking Revlimid. If you have irregular menstrual cycles, you will
have pregnancy tests every week for the first 4 weeks, then every 2 weeks while taking
Revlimid, again when you have been taken off of Revlimid therapy, and then 14 days and 28
days after you have stopped taking Revlimid.

You will have a bone marrow aspiration performed before starting treatment (within 4 weeks)
on this study and at about 12 weeks after starting treatment on this study. Your doctor may
also decide to perform a bone marrow aspiration before 12 weeks to assess your response to
treatment. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed
with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.

If you are found to be eligible to take part in this study, you will take Revlimid once a
day by mouth (with a full glass of water, at least 1 hour before or after a meal) for 21
days. Swallow Revlimid capsules whole with water at the same time each day. Do not break,
chew or open the capsules. If you miss a dose of Revlimid, take it as soon as you remember
on the same day. If you miss taking your dose for the entire day, take your regular dose
the next scheduled day (do NOT take double your regular dose to make up for the missed
dose).

If you take more than the prescribed dose of Revlimid you should seek emergency medical care
if needed and contact study staff immediately.

You will then have 7 days off of the study drug, which is considered a rest period. This
entire period is considered 1 cycle of therapy (28 days). The number of treatment cycles
you may have will depend on the response of your disease to treatment on this study. You
will have blood drawn (about 3 tablespoons) to test for blood counts and chemistries before
each treatment cycle. At the end of 3 cycles, your disease will be evaluated for response
to the study treatment. The study doctor may evaluate you sooner if it is necessary. You
will be asked to maintain a study drug diary to record your study medication, the date and
time you take it, and any side effects you may experience. This study drug diary will need
to be taken to each study visit for review.

You will be required to return to M. D. Anderson once a month for the first 3 months on this
study or as often as the study doctor thinks it is best. If your disease is not getting
worse, you are not experiencing any intolerable side effects, and if the study doctor thinks
it is in your best interest, you may continue to return once every month for treatment. You
will be asked to return any unused study drug to Biologics Clinical Trial Division at the
end of each study cycle. During each visit, you will always receive enough study drug to
last until the next visit.

After the first 3 months on this study, you may have blood drawn (about 3 tablespoons) for
blood counts and chemistries at your regular doctor's office. The results of your blood
tests will then be sent to the research nurse. Your side effects will be reviewed by a
doctor or nurse by telephone (in addition to being reviewed in your study diary) before the
start of each cycle of treatment. This phone call will last about 10 minutes each time.

You will be taken off this study if your disease gets worse or you experience any
intolerable side effects. It is also possible that the study doctor may decide to take you
off this study if your disease response is considered less than a complete response. You
will have an end-of-study visit, if you are taken off this study for any reason. During the
end-of-study visit, you will have blood drawn (about 3 tablespoons) for blood counts and
chemistries. You will have an ECG. You may have a urine pregnancy test. You will also
have a bone marrow aspiration performed.

This is an investigational study. Revlimid® (lenalidomide) is indicated for the treatment
of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk
myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or
without additional cytogenetic abnormalities. Revlimid® is also approved in combination
with dexamethasone for the treatment of patients with multiple myeloma that have received at
least one prior therapy. In this case it will be considered investigational. Up to 30
patients will take part in this study. All will be enrolled at M. D. Anderson.