Table 1.

Criteria for diagnosis and risk of progression in MGUS

Subtype of MGUSDiagnostic criteriaRisk of progressionPattern of progression
IgM MGUS All 3 criteria must be met: 1% per year Waldenström macroglobulinemia, AL amyloidosis; rarely IgM multiple myeloma 
 • Serum IgM monoclonal protein <3 gm/dL 
 • Bone marrow lymphoplasmacytic infiltration <10%* 
 • No evidence of anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, or hepatosplenomegaly that can be attributed to the underlying lymphoproliferative disorder 
Non-IgM MGUS All 3 criteria must be met: 0.5% per year Multiple myeloma, solitary plasmacytoma, AL amyloidosis 
 • Serum monoclonal protein (non-IgM type) <3 gm/dL 
 • Clonal bone marrow plasma cells <10%* 
 • Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) that can be attributed to the plasma cell proliferative disorder 
Light-chain MGUS All criteria must be met: 0.3% per year Light-chain multiple myeloma and AL amyloidosis 
 • Abnormal FLC ratio (<0.26 or >1.65) 
 • Increased level of involved light chain (increased κ FLC in patients with FLC ratio >1.65 and increased λ FLC in patients with FLC ratio <0.26) 
 • No immunoglobulin heavy-chain expression on immunofixation 
 • Absence of end-organ damage that can be attributed to the plasma cell proliferative disorder 
 • Clonal bone marrow plasma cells <10%* 
 • Urinary monoclonal protein <500 mg per 24 h 
Subtype of MGUSDiagnostic criteriaRisk of progressionPattern of progression
IgM MGUS All 3 criteria must be met: 1% per year Waldenström macroglobulinemia, AL amyloidosis; rarely IgM multiple myeloma 
 • Serum IgM monoclonal protein <3 gm/dL 
 • Bone marrow lymphoplasmacytic infiltration <10%* 
 • No evidence of anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, or hepatosplenomegaly that can be attributed to the underlying lymphoproliferative disorder 
Non-IgM MGUS All 3 criteria must be met: 0.5% per year Multiple myeloma, solitary plasmacytoma, AL amyloidosis 
 • Serum monoclonal protein (non-IgM type) <3 gm/dL 
 • Clonal bone marrow plasma cells <10%* 
 • Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) that can be attributed to the plasma cell proliferative disorder 
Light-chain MGUS All criteria must be met: 0.3% per year Light-chain multiple myeloma and AL amyloidosis 
 • Abnormal FLC ratio (<0.26 or >1.65) 
 • Increased level of involved light chain (increased κ FLC in patients with FLC ratio >1.65 and increased λ FLC in patients with FLC ratio <0.26) 
 • No immunoglobulin heavy-chain expression on immunofixation 
 • Absence of end-organ damage that can be attributed to the plasma cell proliferative disorder 
 • Clonal bone marrow plasma cells <10%* 
 • Urinary monoclonal protein <500 mg per 24 h 

Adapted from Rajkumar et al with permission.

FLC, free light chain.

*

A bone marrow can be deferred in patients with small (<1.5 gm/dL) IgM MGUS, low-risk MGUS (IgG type, M- protein <1.5 gm/dL, normal free light-chain ratio), and small (involved/uninvolved serum-free light-chain ratio <8) light-chain MGUS in whom there are no clinical features concerning for myeloma or lymphoplasmacytic malignancy.

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