The International Myeloma Working Group (IMWG) consensus updates the disease definition of multiple myeloma to include validated biomarkers in addition to existing requirements of attributable CRAB features (hypercalcaemia, renal failure, anaemia, and bone lesions).
Revised International Myeloma Working Group diagnostic criteria for multiple
myeloma and smouldering multiple myeloma
Definition of multiple myeloma
Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary
plasmacytoma* and any one or more of the following myeloma defining events:
• Myeloma defining events:
• Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
• Hypercalcaemia: 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 insuffi ciency: creatinine clearance <40 mL per min† or serum creatinine
>177 μmol/L (>2 mg/dL)
• Anaemia: haemoglobin value of >20 g/L below the lower limit of normal, or a
haemoglobin value <100 g/L
• Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or
• Any one or more of the following biomarkers of malignancy:
• Clonal bone marrow plasma cell percentage* ≥60%
• Involved:uninvolved serum free light chain ratio§ ≥100
• >1 focal lesions on MRI studies¶
Definition of smouldering multiple myeloma
Both criteria must be met:
• Serum monoclonal protein (IgG or IgA) ≥30 g/L or urinary monoclonal protein ≥500 mg
per 24 h and/or clonal bone marrow plasma cells 10–60%
• Absence of myeloma defi ning events or amyloidosis
PET-CT=¹⁸F-fl uorodeoxyglucose PET with CT.
*Clonality should be established by showing κ/λ-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone marrow plasma cell percentage should preferably be estimated from a core biopsy specimen; in case of a disparity between the aspirate and core biopsy, the highest value should be used
†Measured or estimated by validated equations.
‡If bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement.
§These values are based on the serum Freelite assay (The Binding Site Group, Birmingham, UK). The involved free light chain must be ≥100 mg/L.
¶Each focal lesion must be 5 mm or more in size.
- Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. [Medline]
- Rajkumar SV. Updated Diagnostic Criteria and Staging System for Multiple Myeloma. Am Soc Clin Oncol Educ Book. 2016;35:e418-23. [Medline]
Created Mar 21, 2018.