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. 2015 Aug;32(Suppl 7):49S–56S.

Table 1.

Diagnostic Criteria

Monoclonal gammopathy of undetermined significance
  • Serum monoclonal protein < 3 g/dL

  • Clonal bone marrow plasma cells < 10%

  • Absence of end organ damage attributed to the plasma cell disorder (hypercalcemia, renal failure, anemia, bone lesions)

Smoldering multiple myeloma
  • Serum monoclonal protein (IgG or IgA) > 3 g/dL and/or clonal bone marrow plasma cells 10%-60%

  • Absence of end organ damage attributable to plasma cell disorder

Multiple myeloma
  • Clonal bone marrow plasma cells > 10% or

  • Biopsy proven plasmacytoma and

    Evidence of end organ damage attributable to underlying plasma cell disorder:

    • Serum calcium > 11.5 mg/dL, and/or

    • Renal insufficiency: serum creatinine > 2 mg/dL, and/or

    • Anemia: hemoglobin < 10 g/dL or > 2 g/dL below lower limit of normal, and/or

    • Bone lesions: lytic lesions, severe osteopenia, or pathological fractures

  • If no end organ damage, then clonal plasma cells > 60%