Hematologic Response

Complete Response

Requires all of the following:

  • Serum and urine negative for monoclonal proteins by immunofixation
  • Normal free light chain ratio
  • Plasma cells in marrow < 5%

Partial Response (PR)

Requires any of the following:

  • ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL
  • ≥ 50% reduction in current urine m-protein levels > 100 mg/day with a visible peak
  • ≥ 50% reduction in current free light chain levels > 10mg/dL

No Response (NR)/Stable Disease (SD)

Does not meet the criteria for CR, PR, or progressive disease.

Progressive Disease (PD)

Requires any of the following:

  • If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double)
  • If progressive from PR or SD, ≥ 50% increase in the serum M protein to > 0.5 g/dL, or ≥ 50% increase in urine M protein to > 200mg/day with visible peak present.
  • Free light chain increase of ≥ 50% to > 10 mg/dL (100 mg/L)

Cardiac Response

Cardiac Response

Requires any of the following:

  • ≥ 2 mm decrease in mean intraventricular septal wall thickness by echocardiogram
  • ≥ 20% increase in left ventricular ejection fraction
  • ≥ 2 grade decrease in New York Heart Association functional class without an increase in diuretic use and no increase in wall thickness
  • Reduction (≥ 30% and ≥ 300ng/L) of NT-proBNP in patients whom the eGFR is ≥ 45 ml/minute/1.73m2

No Response/Stable Disease

Does not meet the criteria for cardiac response or progressive disease

Progressive Disease

Requires any of the following:

  • ≥ 2 mm increase from baseline in the intraventricular wall thickness by echocardiogram
  • ≥ 10% decrease in the left ventricular ejection fraction.
  • ≥ 1 grade increase in New York Heart Association functional class

Hepatic Response

Hepatic Response

Requires all of the following:

  • ≥ 2 cm decrease in liver span if hepatomegaly present (liver > 15 cm)
  • ≥ 50% decrease and/or normalization of serum alkaline phosphatase (ALP) level

No Response/Stable Disease

Does not meet the criteria for hepatic response or progressive disease

Progressive Disease

Requires the following:

  • ≥ 50% increase in the serum alkaline phosphatase (ALP) level

Autonomic Neuropathy Response

Autonomic Neuropathy Response

Resolution of symptomatic orthostatic hypotension

No Response/Stable Disease

Does not meet the criteria for autonomic neuropathy response or progressive disease

Progressive Disease

Worsening of symptomatic orthostatic hypotension

Peripheral Neuropathy Response

Peripheral Neuropathy Response

Requires any of the following:

  • Resolution of abnormal physical findings
  • Resolution or improvement of abnormal electromyography (EMG) and/or Nerve Conduction Velocity (NCV) findings

No Response/Stable Disease

Does not meet the criteria for peripheral neuropathy response or progressive disease

Progressive Disease

Requires any of the following:

  • Worsening of physical findings
  • Worsening of EMG and/or NCV findings

Renal Response

Renal Response

  • ≥ 50% decrease of at least 0.5 g/day (500mg/24hr) in 24-hour urine protein of > 0.5 g/day (500mg/24hr) pre-treatment and
  • Creatinine clearance or serum creatinine must not have worsened by ≥ 25% over baseline

If only serum creatinine is obtained, an estimated creatinine clearance can be calculated using the following formula:

Estimated Creatinine Clearance = [(140 – Age (years)) * Weight (kg)] / [72 * Serum Creatinine (mg/dL)]
The calculation should be multiplied by 0.85 for women

No Response/Stable Disease

Does not meet the criteria for renal response or progressive disease

Progressive Disease

Requires any of the following:

  • ≥ 50% increase of at least 1 g/day (1000mg/24hr) for urine protein to > 1g/day (1000mg/24hr)
  • 25% worsening of serum creatinine or creatinine clearance

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 Amyloidosis Response Criteria Modify Modified the following sections (removed text is struck out below, added text is in red) of the Amyloidosis Response Criteria:
Partial Response:
  • ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL
  • ≥ 50% reduction in current urine light chain urine m-protein levels > 100 mg/day with a visible peak
  • ≥ 50% reduction in current free light chain levels > 10mg/dL
    Renal Response:
  • ≥ 50% decrease of at least 0.5 g/day (500mg/24hr) in 24-hour urine protein of > 0.5 g/day (500mg/24hr) pre-treatment and
  • Creatinine clearance or serum creatinine must not have worsened by ≥ 25% over baseline
    If only serum creatinine is obtained, an estimated creatinine clearance can be calculated using the following formula:
    Estimated Creatinine Clearance = [(140 – Age (years)) * Weight (kg)] / [72 * Serum Creatinine (mg/dL)]
    The calculation should be multiplied by 0.85 for women.
12/3/18 Amyloidosis Response Criteria Add Added further clarification for the Renal Response criteria (indicated in red below):
  • ≥ 50% decrease of at least 0.5 g/day (500mg/24hr) in 24-hour urine protein of > 0.5 g/day (500mg/24hr) pre-treatment and
  • Creatinine clearance must not have worsened by ≥ 25% over baseline
Last modified: 2019/04/19

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