Unifying Concepts

Diagnostic Criteria for Multiple Myeloma

Presence of an M-componenta in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma.

PLUS one or more of the following:b

  • Calcium elevation (>11.5 mg/dl) [>2.65 mmol/l]
  • Renal insufficiency (creatinine >2 mg/dl) [177 mmol/l or more]
  • Anemia (hemoglobin <10 g/dl or 2 g/dl <normal) (hemoglobin <12.5 mmol/lc or 1.25 mmol/l <normal)
  • Bone disease (lytic lesions or osteopenia)

aIn patients with no detectable M-component, an abnormal serum FLC ratio on the serum FLC assay can substitute and satisfy this criterion. For patients, with no serum or urine M-component and normal serum FLC ratio, the baseline bone marrow must have >10% clonal plasma cells; these patients are referred to as having ‘non-secretory myeloma’. Patients with biopsy-proven amyloidosis and/or systemic light chain deposition disease (LCDD) should be classified as ‘myeloma with documented amyloidosis’ or ‘myeloma with documented LCDD,’ respectively if they have >30% plasma cells and/or myeloma-related bone disease.

bMust be attributable to the underlying plasma cell disorder.

cNote: Hemoglobin of 10 g/dl is 12.5 mmol/l [or 100 g/l].

Myeloma-related organ dysfunction (CRAB criteria)

  • Hypercalcemia (serum calcium >11.5 mg/dl [2.88 mmol/liter])
  • Renal insufficiency (serum creatinine >2 mg/dl [177 umol/liter])
  • Anemia (hemoglobin <10 g/dl or >2 g/dl below the lower limit of the normal range)
  • Bone disease (lytic lesions, severe osteopenia, or pathologic fracture)

International Staging System

  • Stage I: serum B2-microglobulin <3.5 mg/liter, serum albumin >/=3.5 g/dl
  • Stage II: serum B2-microglobulin, <3.5mg/liter plus serum albumin <3.5 g/dl; or serum B2-microglobulin 3.5 to <5.5 mg/liter regardless of serum albumin level
  • Stage III: serum B2-microglobulin >/=5.5 mg/liter

Chromosomal abnormalities

  • High-risk: presence of t(4;14) or deletion 17p13 detected by fluorescence in situ hybridization
  • Standard-risk: t(11;14) detected by fluorescence in situ hybridization



  1. Durie BG, Harousseau JL, Miguel JS, Bladé J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. [Medline]
  2. Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. [Medline]


Created: Jun 17, 2007

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