The following criteria is provided for health care professionals.

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