This research is a Phase I clinical trial. Phase I clinical trials test the safety of an
investigational drug. Phase I studies also try to define the appropriate dose of the
investigational drug to use for further studies. "Investigational" means that the drug 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 lenalidomide for your type of cancer.
Lenalidomide is a drug that alters the immune system and it may also interfere with the
development of tiny blood vessels that help support tumor growth. Therefore, this study will
determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved
by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in
combination with dexamethasone for patients with multiple myeloma (MM) who have received at
least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a
variety of cancer conditions. In this case it is considered experimental.
There are some participants with multiple myeloma or lymphoma who have had very long
remissions after a bone marrow/stem cell transplantation from another person. This is
believed to be the effect of the donor's immune system reaction against the recipient's
multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it
might be able to potentiate that reaction. This study is being done to determine if the use
of lenalidomide is safe in transplant participants and if it can facilitate an immune
reaction resulting in regression of the myeloma or lymphoma.
During this study you will be evaluated for side effects from the treatment with lenalidomide
(including graft versus host disease) and for response of the myeloma to the treatment. There
will be two groups of participants in the study. The first group will be treated at a
relatively low dose of lenalidomide. If this is found to be safe then the second group will
be treated at a higher dose