Myeloma E3A06

April 27, 2017


Sponsor: National Cancer Institute (NCI)

Number: E3A06

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II/III trial which studies how well Lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering, an early precursor to blood cancer) multiple myeloma. (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely). 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.

Who’s eligible:

  • Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following:
    • Bone marrow plasmacytosis (a condition in which there is an unusually large proportion of plasma cells in tissues) with >= 10% plasma cells or sheets of plasma cells at any time before initiating study treatment. This includes a marrow which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization
    • Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light chain assay; FLC assay must be performed within 28 days of randomization. FLC is  a test ordered to help detect, diagnose, and monitor plasma cell disorders.
  • Patients must have measurable levels of monoclonal protein (M-protein): >= 1g/dL on serum protein electrophoresis or >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis (a test that measures specific proteins in the blood) which must be obtained within 4 weeks prior to randomization.
  • This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.

Cancer Clinical Research Office