A Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic 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.

Key Eligibility:

• Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months

• Patients must have measurable levels of monoclonal protein (M-protein): greater than and equal to 1g/dL on serum protein electrophoresis or greater than and equal to 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization

• No prior or concurrent systemic or radiation therapy for the treatment of myeloma

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

• Patients should not be felt to have an immediate need for chemotherapy
Phase III
Alison Conlin, M.D.
Laurie Delanty

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.