Criteria

International Myeloma Working Group (IMWG) updated diagnostic criteria[1]

Monoclonal gammopathy of unknown significance (MGUS):

  • Monoclonal (M) protein in the serum (<30 g/L [3 g/dL]) or in urine (<500 mg per 24 hours)

  • Bone marrow clonal cells <10% (a bone marrow examination is only required if M protein is >15 g/L [1.5 g/dL], or for non-IgG MGUS, or if the free light chain ratio is abnormal)

  • Absence of signs of end-organ damage that can be attributed to the plasma cell proliferative process (e.g., hypercalcaemia, renal insufficiency, anaemia, bone lesions, or amyloidosis).

Asymptomatic (smouldering) myeloma:

  • M protein in the serum (≥30 g/L [3 g/dL]) or in urine (≥500 mg per 24 hours), and/or bone marrow clonal cells 10% to 60%

  • Absence of signs of end-organ damage that can be attributed to the plasma cell proliferative process (e.g., hypercalcaemia, renal insufficiency, anaemia, bone lesions, or amyloidosis).

Active (symptomatic) myeloma:

  • Bone marrow clonal cells ≥10%, or biopsy-proven bony or extramedullary plasmacytoma, and 1 or more of the following:

    • Evidence of end-organ damage that can be attributed to the plasma cell proliferative process (e.g., hypercalcaemia, renal insufficiency, anaemia, bone lesions, or amyloidosis)

    • Bone marrow clonal cells ≥60%

    • Involved:uninvolved serum free light chain ratio ≥100

    • >1 focal lesion (5 mm or more in size) on magnetic resonance imaging studies

  • Presence of M protein in serum or urine in addition to the above criteria indicates secretory myeloma.

Solitary plasmacytoma and systemic immunoglobulin light chain amyloidosis are also defined as distinct entities.

Risk stratification[30]

The Mayo Clinic has developed a risk-stratification model for disease progression based on 3 adverse risk factors:

  • Serum M protein level >15 g/L (1.5 g/dL)

  • Non-IgG MGUS

  • Abnormal serum free light chain ratio.

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