Table 3 Diagnostic criteria

From: International Myeloma Working Group guidelines for the management of multiple myeloma patients ineligible for standard high-dose chemotherapy with autologous stem cell transplantation

Diagnosis Diagnostic criteria: all three required
Symptomatic multiple myelomaa Monoclonal plasma cells in the bone marrow 10% and/or presence of a biopsy-proven plasmacytoma
  Monoclonal protein present in the serum and/or urineb
  Myeloma-related organ dysfunction (1)c
   [C] Calcium elevation in the blood (serum calcium >10.5 mg/l or upper limit of normal
   [R] Renal insufficiency (serum creatinine >2 mg per 100 ml)
   [A] Anaemia (haemoglobin <10 g per 100 ml or 2 g<normal)
   [B] Lytic bone lesions or osteoporosisd
Monoclonal gammopathy of undetermined significance (MGUS) Serum monoclonal protein lowe
  Monoclonal bone marrow plasma cells <10%
  No evidence of end-organ damage attributable to the clonal plasma cell disorder:
   Normal serum calcium, haemoglobin level and serum creatinine
   No bone lesions on full skeletal X-ray survey and/or other imaging if performed
   No clinical or laboratory features of amyloidosis or light chain deposition disease
Smouldering or indolent myelomaf Monoclonal protein present in the serum 3 g per 100 ml or higher or
  Monoclonal plasma cells 10% or greater present in the bone marrow and/or a tissue biopsy
  No evidence of end-organ damage attributable to the clonal plasma cell disorder:
   Normal serum calcium, haemoglobin level and serum creatinine
   No bone lesions on full skeletal X-ray survey and/or other imaging if performed
   No clinical or laboratory features of amyloidosis or light chain deposition disease
Solitary plasmacytoma of bone Biopsy-proven plasmacytoma of bone in a single site only. X-rays and magnetic resonance imaging and/or FDG PET imaging (if performed) 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 no monoclonal plasma cells
  No other myeloma-related organ dysfunction
  1. Adapted with permission from Kyle and Rajkumar.73
  2. aThese criteria identify Stage IB and Stages II and III A/B myeloma by Durie/Salmon stage. Stage IA becomes smouldering or indolent myeloma.
  3. bIf no monoclonal protein is detected (non-secretory disease), then 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.
  4. cA 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.
  5. dIf 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.
  6. eLow is defined as serum M protein <3.0 g per 100 ml.
  7. fThese criteria identify Stage IA myeloma by Durie/Salmon stage.