Multiple myeloma diagnostic criteria

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief:  Hannan Javed, M.D.[2]; Serge Korjian M.D.; Shyam Patel [3]

## Overview

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The diagnosis of monoclonal gammopathy of undetermined significance requires the presence of clonal plasma cells < 10% and serum monoclonal protein <3g/dl but the absence of end-organ damage. The diagnosis of smoldering multiple myeloma requires the presence of clonal plasma cells 10%-60% and serum monoclonal protein >3g/dl but the absence of end-organ damage. The diagnosis of active multiple myeloma requires the presence of end-organ damage. 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]

## Diagnostic Criteria

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### Revised Criteria for the Diagnosis of Multiple Myeloma

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The diagnosis of multiple myeloma requires the following:[1][2][3][4]

* ≥10% clonal plasma cells in bone marrow

* biopsy-proven bony or extramedullary plasmacytoma,

With one or more of the myeloma-defining events:

* CRAB features:
* 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
* Biomarkers of malignancy:
* 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

Revised Criteria for the Diagnosis of Multiple Myeloma

* ≥10% clonal plasma cells in bone marrow

* Biopsy-proven bony or extramedullary plasmacytoma with one or more of the following:
* 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

### Criteria for the Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS)

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All three criteria must be met:[1][2][3]

* 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

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Both criteria must be met:[1][2]

* 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

### Criteria for the Diagnosis of Solitary Plasmacytoma

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All four criteria must be met:[2]

* Biopsy-proven solitary lesion of bone or soft tissue with evidence of clonal plasma cells
* Normal bone marrow with no evidence of clonal plasma cells
* Normal skeletal survey and MRI of spine and pelvis (except for the primary solitary lesion)
* No evidence of end-organ damage such as CRAB lesions that can be attributed to a lymphoplasma cell proliferative disorder

## References

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1. ↑ 1.0 1.1 1.2 1.3 Rajkumar, S. Vincent, Meletios A. Dimopoulos, Antonio Palumbo, Joan Blade, Giampaolo Merlini, María-Victoria Mateos, Shaji Kumar et al. "International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma." The Lancet Oncology 15, no. 12 (2014): e538-e548
2. ↑ 2.0 2.1 2.2 2.3 Kyle RA, Rajkumar SV (January 2009). "Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma". Leukemia. 23 (1): 3–9. doi:10.1038/leu.2008.291. PMC 2627786. PMID 18971951.
3. ↑ 3.0 3.1 "Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group". Br. J. Haematol. 121 (5): 749–57. June 2003. PMID 12780789.
4. ↑ Rajkumar SV, Kyle RA (October 2005). "Multiple myeloma: diagnosis and treatment". Mayo Clin. Proc. 80 (10): 1371–82. doi:10.4065/80.10.1371. PMID 16212152.