Multiple myeloma diagnostic criteria
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Serge Korjian M.D. Shyam Patel [2]
Overview
The International Myeloma Working Group (IMWG) proposed updated criteria for the diagnosis of multiple myeloma in November 2014. The diagnosis requires >10% clonal plasma cell proliferation in the bone marrow, or biopsy-proven plasmacytosis at an extramedullary site plus one of more of the multiple myeloma-defining CRAB features (hypercalcemia, renal failure, anaemia, and bone lesions) or one or more of the newly added biomarkers of malignancy (clonal bone marrow plasma cell percentage ≥60%, involved:uninvolved serum free light chain ratio ≥100, and >1 focal lesions on MRI studies).[1]
Diagnostic Criteria
In November 2014, the International Myeloma Working Group (IMWG) updated the criteria for the diagnosis of multiple myeloma to include novel validated biomarkers to better encompass the extent of disease. Prior to 2014, the original diagnostic criteria for end-organ damage included CRAB features (hypercalcemia, renal failure, anemia, and bone lesions) without consideration of the plasma cell burden or free light chain ratio. The 2014 update also clarified the underlying laboratory and radiographic findings of CRAB features, as well as the histological and monoclonal protein requirements for the disease diagnosis.[1]
Criteria for the Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS)
All three criteria must be met:
- Presence of serum monoclonal protein (IgG or IgA) <3 g/dL
- Presence of bone marrow clonal plasma cells <10%
- Absence of multiple myeloma-defining events or amyloidosis
Criteria for the Diagnosis of Smoldering Multiple Myeloma
Both criteria must be met[1]:
- Serum monoclonal protein (IgG or IgA) ≥3 g/dL or urinary monoclonal protein ≥500 mg per 24 h and/or clonal bone marrow plasma cells 10–60%
- Absence of multiple myeloma-defining events or amyloidosis
Revised Criteria for the Diagnosis of Multiple Myeloma
Both criteria must be met:[1]
- ≥10% clonal expansion of bone marrow plasma cells or biopsy-proven bony or extramedullary plasmacytoma, and one or more of the following 7 features:
- Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder:
- 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 per min or serum creatinine >177 μmol/L (>2 mg/dL)
- Anemia: hemoglobin value of >2 g/dL below the lower limit of normal, or a hemoglobin value <10 g/dL
- Bone lesion: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT
- Bone marrow plasma cell burden: Clonal bone marrow plasma cell percentage ≥60%
- Free light chain ratio: Involved-to-uninvolved free light chain ratio ≥100
- MRI: >1 focal bony lesion of 5mm or greater on MRI studies