Presence of an M-component^a in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma.

PLUS one or more of the following:^b

• Calcium elevation (>11.5 mg/dl) [>2.65 mmol/l]
• Renal insufficiency (creatinine >2 mg/dl) [177 mmol/l or more]
• Anemia (hemoglobin <10 g/dl or 2 g/dl <normal) (hemoglobin <12.5 mmol/l^c or 1.25 mmol/l <normal)
• Bone disease (lytic lesions or osteopenia)

^aIn patients with no detectable M-component, an abnormal serum FLC ratio on the serum FLC assay can substitute and satisfy this criterion. For patients, with no serum or urine M-component and normal serum FLC ratio, the baseline bone marrow must have >10% clonal plasma cells; these patients are referred to as having ‘non-secretory myeloma’. Patients with biopsy-proven amyloidosis and/or systemic light chain deposition disease (LCDD) should be classified as ‘myeloma with documented amyloidosis’ or ‘myeloma with documented LCDD,’ respectively if they have >30% plasma cells and/or myeloma-related bone disease.

^bMust be attributable to the underlying plasma cell disorder.

^cNote: Hemoglobin of 10 g/dl is 12.5 mmol/l [or 100 g/l].