Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

This randomized phase II/III trial studies how well lenalidomide works and compares it to
observation in treating patients with asymptomatic high-risk asymptomatic (smoldering)
multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system
in different ways and stop cancer cells from growing. Sometimes the cancer may not need
treatment until it progresses. In this case, observation may be sufficient. It is not yet
known whether lenalidomide is effective in treating patients with high-risk smoldering
multiple myeloma than observation alone.