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. Author manuscript; available in PMC: 2016 Apr 12.
Published in final edited form as: Expert Opin Orphan Drugs. 2015 Apr 12;3(6):10.1517/21678707.2015.1036740. doi: 10.1517/21678707.2015.1036740

Table 1.

Definition of MGUS, SMM and symptomatic multiple myeloma.

International Myeloma Working Group criteria, 2010 version [35]
MGUS Serum M protein < 3 g/dl
Clonal bone marrow plasma cells < 10%
Absence of myeloma defining events and amyloidosis
SMM Serum M protein ≥ 3 g/dl
and/or clonal bone marrow plasma cells 10 - 60%
or urinary monoclonal protein > 500 mg per 24
or FLC ratio < 0.125 or > 8
or ≥ 95% abnormal plasma cells in the bone marrow
or immunoparesis of one or more immunoglobulins
Absence of myeloma defining events and amyloidosis
MM Clonal bone marrow plasma cells ≥ 10% and/or biopsy proven plasmacytoma
Presence of serum and/or urinary monoclonal protein at any level
CRAB criteria Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder (CRAB criteria)
Hypercalcemia: serum calcium > 0.25 mmol/l above upper limit of normal or > 2.75 mmol/l (> 1 mg/dl above upper limit of normal)
Renal insufficiency: creatinine clearance < 40 ml per min or serum creatinine > 177 μmol/l (> 2 mg/dl) Anemia: normochromic, normocytic with a hemoglobin value of > 2 g/dl below the lower limit of normal or a hemoglobin value < 10 g/dl
Bone lesions: lytic lesions, or osteoporosis with compression fractures. If osteoporosis is used as the sole criterion, then the bone marrow has to be > 30% involved
MDE criteria Or any MDE as follows:
Clonal bone marrow plasma cell percentage ≥ 60% [22]
An abnormal FLC-ratio ≥ 100 (involved kappa) or < 0.01 (involved lambda) [23]
Two or more focal lesions on MRI or positron emission tomography-CT studies measuring > 5 mm in diameter [24,25]

FLC: Free light-chain; MDE: Myeloma defining events; MGUS: Monoclonal gammopathy of undermined significance; SMM: Smoldering multiple myeloma