Waldenstrom’s Macroglobulinemia Response Criteria

*Reporting Disease Status on the Pre-TED Disease Classification (2402) Form:
Not all of the Waldenstrom’s Macroglobulinemia response criteria correspond to the option values on the current Pre-TED Disease Classification (2402) Form. Please see the italicized text below each response criteria for instructions on how to correctly report the pre-transplant disease response on the Pre-TED Disease Classification (2402) Form.

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.

If the recipient meets the Waldenstrom’s Macroglobulinemia disease response criteria for a Complete response (CR) prior to infusion, report the pre-infusion disease status on the Pre-TED Disease Classification (2402) Form as “Complete Response (CR).”

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

If the recipient meets the Waldenstrom’s Macroglobulinemia disease response criteria for a Partial response (PR) prior to infusion, report the pre-infusion disease status on the Pre-TED Disease Classification (2402) Form as:

• “Primary Induction Failure – Sensitive (PIF – sen)” if the recipient has never previously achieved a CR, or
• “Relapse – Sensitive (REL – sen)” if the recipient has previously achieved a CR
  

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

If the recipient meets the Waldenstrom’s Macroglobulinemia disease response criteria for a Minor response / stable disease (MR / SD) prior to infusion, report the pre-infusion disease status on the Pre-TED Disease Classification (2402) Form as:

• “Primary Induction Failure – Resistant (PIF – res)” if the recipient has never previously achieved a CR, or
• “Relapse – Resistant (REL – res)” if the recipient has previously achieved a CR
  

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.

If the recipient meets the Waldenstrom’s Macroglobulinemia disease response criteria for a Progressive disease (PD) prior to infusion, report the pre-infusion disease status on the Pre-TED Disease Classification (2402) Form as:

• “Primary Induction Failure – Resistant (PIF – res)” if the recipient has never previously achieve a CR, or
• “Relapse – Resistant (REL – res)” if the recipient has previously achieved a CR
  

Not assessed

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

If the recipient meets the Waldenstrom’s Macroglobulinemia disease response was not assessed by any method, including a physical examination, prior to infusion, report the pre-infusion disease status on the Pre-TED Disease Classification (2402) Form as:

• “Primary Induction Failure – Unknown (PIF – unk)” if the recipient has never previously achieve a CR, or
• “Relapse – Unknown (REL – res)” if the recipient has previously achieved a CR
  

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
6/11/2020	Waldenstrom’s Macroglobulinemia Response Criteria	Add	Provided clarification on how to report the disease status for recipients with WM on the Pre-TED Disease Classification (2402) Form by adding in the blue instructional box at the top of the response criteria and the italicized instructions below each response option.
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

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