Diagnostic criteria for multiple myeloma and monoclonal gammopathy of unknown significance (MGUS).34
| *A small M-component may sometimes be present. |
| # Myeloma-related organ or tissue impairment (end organ damage) (ROTI): Calcium levels increased: serum calcium > 0.25 mmol/L above the upper limit of normal or > 2.75 mmol/L; Renal insufficiency: creatinine >173 mmol/L; Anemia: hemoglobin 2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: lytic lesions or osteoporosis with compression fractures (MRI or CT may clarify); Other: symptomatic hyper-viscosity, amyloidosis, recurrent bacterial infections (> 2 episodes in 12 months) |
| Monoclonal gammopathy of undetermined significance |
| M-protein in serum ≤30 g/L |
| Bone marrow clonal plasma cells < 10% |
| No evidence of other B-cell proliferative disorders |
| No myeloma related organ or tissue impairment (no end organ damage, including bone lesions)*# |
| Smoldering myeloma |
| M-protein in serum ≥ 30 g/L and/or |
| Bone marrow clonal plasma cells ≥ 10% |
| No related organ or tissue impairment (no end organ damage, including bone lesions) or symptoms*# |
| Symptomatic multiple myeloma |
| Presence of M-protein in serum and/or urine |
| Bone marrow (clonal) plasma cells* or plasmacytoma |
| Related organ or tissue impairment (end organ damage, including bone lesions)*# |
| Solitary plasmacytoma of bone |
| No M-protein in serum and/or urine* |
| Single area of bone destruction due to clonal plasma cells |
| Bone marrow not consistent with multiple myeloma |
| Normal skeletal survey (and MRI of spine and pelvis if done) |
| No related organ or tissue impairment (no end organ damage other than solitary bone lesion)*# |
| Non-secretory myeloma |
| No M-protein in serum and/or urine with immunofixation |
| Bone marrow clonal plasmacytosis ≥ 10% or plasmacytoma |
| Related organ or tissue impairment (end organ damage, including bone lesions)*# |
| *A small M-component may sometimes be present. |
| # Myeloma-related organ or tissue impairment (end organ damage) (ROTI): Calcium levels increased: serum calcium > 0.25 mmol/L above the upper limit of normal or > 2.75 mmol/L; Renal insufficiency: creatinine >173 mmol/L; Anemia: hemoglobin 2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: lytic lesions or osteoporosis with compression fractures (MRI or CT may clarify); Other: symptomatic hyper-viscosity, amyloidosis, recurrent bacterial infections (> 2 episodes in 12 months) |
| Monoclonal gammopathy of undetermined significance |
| M-protein in serum ≤30 g/L |
| Bone marrow clonal plasma cells < 10% |
| No evidence of other B-cell proliferative disorders |
| No myeloma related organ or tissue impairment (no end organ damage, including bone lesions)*# |
| Smoldering myeloma |
| M-protein in serum ≥ 30 g/L and/or |
| Bone marrow clonal plasma cells ≥ 10% |
| No related organ or tissue impairment (no end organ damage, including bone lesions) or symptoms*# |
| Symptomatic multiple myeloma |
| Presence of M-protein in serum and/or urine |
| Bone marrow (clonal) plasma cells* or plasmacytoma |
| Related organ or tissue impairment (end organ damage, including bone lesions)*# |
| Solitary plasmacytoma of bone |
| No M-protein in serum and/or urine* |
| Single area of bone destruction due to clonal plasma cells |
| Bone marrow not consistent with multiple myeloma |
| Normal skeletal survey (and MRI of spine and pelvis if done) |
| No related organ or tissue impairment (no end organ damage other than solitary bone lesion)*# |
| Non-secretory myeloma |
| No M-protein in serum and/or urine with immunofixation |
| Bone marrow clonal plasmacytosis ≥ 10% or plasmacytoma |
| Related organ or tissue impairment (end organ damage, including bone lesions)*# |