Clinical Research Directory

Inclusion Criteria: * Patients with monoclonal gammopathy of unknown significance. Both criteria must be met: * Serum monoclonal protein \< 3 g/dL or urinary monoclonal protein \< 500 mg per 24 hours and clonal bone marrow plasma cells \< 10% * Absence of myeloma defining events or amyloidosis * Patients with smoldering multiple myeloma. Both criteria must be met: * Serum monoclonal protein \>= 3 g/dL or urinary monoclonal protein \>= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60% * Absence of myeloma defining events or amyloidosis Exclusion Criteria: * Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following * Hypercalcemia: serum calcium \> 0.25 mmol/L (\> 1 mg/dL) higher than the upper limit of normal or \> 2.75 mmol/L (\> 11 mg/dL) * Renal Insufficiency: creatinine clearance \< 40 ml/min or serum creatinine \> 2 mg/dL * Anemia: hemoglobin value \< 10 g/dL or 2 g/dL \< normal reference * Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2\[F-18\] fluoro-D-glucose positron emission tomography CT (PET-CT) * Clonal bone marrow plasma cell percentage \>= 60% * Involved:uninvolved serum free light chain ratio \>= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom \[UK\]) * \> 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size) * Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies * Bisphosphonates are permitted * Radiotherapy is not permitted * Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted * Plasma cell leukemia * Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements