Table 1. Plasma cell–related disorder... | American Society of Hematology

Table 1.

Plasma cell–related disorder diagnostic criteria.

	Diagnostic criteria: all three required
*If no monoclonal protein is detected (non-secretory disease), then ≥ 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.
†A variety of other types of end-organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classifications myeloma if proven to be myeloma related.
‡If a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) is the sole defining criteria, then ≥ 30% plasma cells are required in the bone marrow.
§Low is defined as serum IgG < 3.0 g/dL, serum IgA < 2.0 g/dL, and urine monoclonal kappa or lambda <1.0 g/24 hours
MRI indicates magnetic resonance imaging; FDG: fludeoxyglucose; PET: positron emission tomography.
Symptomatic multiple myeloma (MM)	Monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven plasmacytoma Monoclonal protein present in the serum and/or urine* Myeloma-related organ dysfunction (≥ 1)†   [C] Calcium elevation in the blood (serum calcium >10.5 mg/L or upper limit of normal)   [R] Renal insufficiency (serum creatinine >2 mg/dL)   [A] Anemia (hemoglobin <10 g/dL or 2 g <normal)   [B] Lytic bone lesions or osteoporosis‡
Monoclonal gammopathy of undetermined significance (MGUS)	Serum monoclonal IgG <3.0 g/dL, or serum IgA <2.0 g/dL, or urine monoclonal kappa or lambda <1.0 g/24 hours Monoclonal bone marrow plasma cells <10% Normal serum calcium, hemoglobin concentration, and serum creatinine   No bone lesions on full skeletal radiograph survey and/or other imaging if done   No clinical or laboratory features of amyloidosis or light-chain deposition disease
Smouldering or indolent myeloma	Monoclonal protein present in the serum and/or urine Monoclonal plasma cells present in the bone marrow and/or a tissue biopsy Not meeting criteria for MGUS, MM, or solitary plasmacytoma of bone or soft tissue
Solitary plasmacytoma of bone	Biopsy-proven plasmacytoma of bone in one site only. Radiographs and MRI and/or FDG PET imaging (if done) must be negative outside the primary site. The primary lesion may be associated with a low§ serum and/or urine M-component The bone marrow contains <10% monoclonal plasma cells No other myeloma-related organ dysfunction

	Diagnostic criteria: all three required
*If no monoclonal protein is detected (non-secretory disease), then ≥ 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.
†A variety of other types of end-organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classifications myeloma if proven to be myeloma related.
‡If a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) is the sole defining criteria, then ≥ 30% plasma cells are required in the bone marrow.
§Low is defined as serum IgG < 3.0 g/dL, serum IgA < 2.0 g/dL, and urine monoclonal kappa or lambda <1.0 g/24 hours
MRI indicates magnetic resonance imaging; FDG: fludeoxyglucose; PET: positron emission tomography.
Symptomatic multiple myeloma (MM)	Monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven plasmacytoma Monoclonal protein present in the serum and/or urine* Myeloma-related organ dysfunction (≥ 1)†   [C] Calcium elevation in the blood (serum calcium >10.5 mg/L or upper limit of normal)   [R] Renal insufficiency (serum creatinine >2 mg/dL)   [A] Anemia (hemoglobin <10 g/dL or 2 g <normal)   [B] Lytic bone lesions or osteoporosis‡
Monoclonal gammopathy of undetermined significance (MGUS)	Serum monoclonal IgG <3.0 g/dL, or serum IgA <2.0 g/dL, or urine monoclonal kappa or lambda <1.0 g/24 hours Monoclonal bone marrow plasma cells <10% Normal serum calcium, hemoglobin concentration, and serum creatinine   No bone lesions on full skeletal radiograph survey and/or other imaging if done   No clinical or laboratory features of amyloidosis or light-chain deposition disease
Smouldering or indolent myeloma	Monoclonal protein present in the serum and/or urine Monoclonal plasma cells present in the bone marrow and/or a tissue biopsy Not meeting criteria for MGUS, MM, or solitary plasmacytoma of bone or soft tissue
Solitary plasmacytoma of bone	Biopsy-proven plasmacytoma of bone in one site only. Radiographs and MRI and/or FDG PET imaging (if done) must be negative outside the primary site. The primary lesion may be associated with a low§ serum and/or urine M-component The bone marrow contains <10% monoclonal plasma cells No other myeloma-related organ dysfunction