Myeloma CC-4047-MM-007

April 27, 2017

Sponsor: Celgene

Number: CC-4047-MM-007 

The purpose of this study is to compare the efficacy of the combination of Pomalidomide, Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of Bortezomib and Dexamethasone.

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, including 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 (FLC) assay. FLC assay must be performed within 28 days of randomization (FLC- 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 (separates macromolecules based on size) or >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis 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.