Table 4.

Criteria for hematologic response.

* Given the assay imprecision, it is recommended that serum free light chain (FLC) values below 10 mg/dL, are not considered criteria for evaluation of hematologic response. In addition, the κ/λ ratio in patients with renal failure may be reduced by retention of healthy polyclonal free light chains. Caution should also be used in interpreting data between laboratories and if antisera batches vary over time. 
Complete response (CR) 
  • Serum and urine negative for a monoclonal protein by immunofixation

  • Free light chain ratio normal

  • Marrow contains < 5% plasma cells

 
Partial response (PR) 
  • If serum M component > 0.5 g/dL, a 50% reduction

  • If light chain in the urine with a visible peak and > 100 mg/day and 50% reduction

  • If free light chain > 10 mg/dL* and 50% reduction

 
Progression 
  • From CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double)

  • From PR or stable response, 50% increase in serum M protein to > 0.5 g/dL or 50% increase in urine

  • M protein to > 200 mg/day; a visible peak must be present

  • Free light chain increase of 50% to > 10 mg/dL

 
Stable 
  • No CR, no PR, no progression

 
* Given the assay imprecision, it is recommended that serum free light chain (FLC) values below 10 mg/dL, are not considered criteria for evaluation of hematologic response. In addition, the κ/λ ratio in patients with renal failure may be reduced by retention of healthy polyclonal free light chains. Caution should also be used in interpreting data between laboratories and if antisera batches vary over time. 
Complete response (CR) 
  • Serum and urine negative for a monoclonal protein by immunofixation

  • Free light chain ratio normal

  • Marrow contains < 5% plasma cells

 
Partial response (PR) 
  • If serum M component > 0.5 g/dL, a 50% reduction

  • If light chain in the urine with a visible peak and > 100 mg/day and 50% reduction

  • If free light chain > 10 mg/dL* and 50% reduction

 
Progression 
  • From CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double)

  • From PR or stable response, 50% increase in serum M protein to > 0.5 g/dL or 50% increase in urine

  • M protein to > 200 mg/day; a visible peak must be present

  • Free light chain increase of 50% to > 10 mg/dL

 
Stable 
  • No CR, no PR, no progression

 

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