This research study is a Phase I clinical trial. Phase I clinical trials test the safety of
an investigational combination of drugs. Phase I studies also try to define the appropriate
dose of the investigational combination of drugs to use for further studies.
"Investigational" means that the combination of drugs is still being studied and that
research doctors are trying to find out more about it. It also means that the FDA has not
approved this combination of drugs for AML. As part of this research study, you will take
lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are
commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with
multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered
investigational in this research study because it is not approved by the FDA for patients
with AML.
Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or
IMID. This drug is successful in the treatment of patients with multiple myeloma and some
patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that
lenalidomide may also be effective in patients with AML. Since we know that many patients who
receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia),
we are studying the addition of lenalidomide to MEC.
In this research study, we are looking for the highest dose of lenalidomide that can be given
safely with MEC.