Complete response (CR)

  • Disappearance of monoclonal protein on immunofixation (both serum and urine)
  • No histologic evidence of bone marrow involvement
  • Resolution of adenopathy and/or organomegaly on CT
  • Resolution of clinical signs or symptoms attributed to WM/LPL

Complete response requires confirmatory immunofixation.

Partial response (PR)

  • ≥ 50% reduction of serum monoclonal IgM spike on serum electrophoresis
  • ≥ 50% reduction of adenopathy and organomegaly on physical exam or CT
  • No new symptoms and no clinical signs of active disease

Minor response/stable disease (MR/SD)

  • 25–49% reduction of serum monoclonal IgM spike on serum electrophoresis
  • No new symptoms and no clinical signs of active disease
    Or
  • < 25% reduction and < 25% increase of serum monoclonal IgM spike on serum electrophoresis
  • No progression of adenopathy, organomegaly, cytopenias, or clinically significant symptoms attributed to WM/LPL

Progressive disease (PD)

  • ≥ 25% increase in serum monoclonal IgM spike from lowest nadir on serum electrophoresis and/or
  • Progression of clinically significant findings or symptoms (for example, anemia, adenopathy, constitutional symptoms, amyloidosis, etc.) attributed to WM/LPL

Progression identified by increasing monoclonal protein on serum electrophoresis requires confirmatory test.

Not assessed

Patient’s disease was not assessed by any method, including physical examination.

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals webpage.

Date Manual Section Add/Remove/Modify Description
4/19/19 Waldenstrom’s Macroglobulinemia Response Criteria Add Added (in red below) the following text for the Progressive Disease response criteria:
  • Progressive disease (PD)*
  • ≥ 25% increase in serum monoclonal IgM spike from lowest nadir on serum electrophoresis and/or
  • Progression of clinically significant findings or symptoms (for example, anemia, adenopathy, constitutional symptoms, amyloidosis, etc.) attributed to WM/LPL
Last modified: Apr 19, 2019

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