General Reporting Guidelines

  • At any response level, if some but not all criteria are met, the disease status should be downgraded to next lower level of response.
  • The percentage of plasma cells in the bone marrow aspirate and / or biopsy may also be identified on a flow cytometry report. A flow cytometry report may NOT be used to confirm CR (e.g., < 5% plasma cells in the bone marrow).
  • Immunofixation (IFE) and immunoelectrophoresis (IEP) are essentially measuring the same thing and either may be used to determine CR. Electrophoresis (SPEP and UPEP) are, however, different assessments.

Stringent Complete Remission (sCR)

Follows criteria for CR as defined below, plus all of the following:

  • No malignant plasma cells in the bone marrow and peripheral blood by flow cytometry; and
  • Normal serum free light chain (FLC) ratio

sCR by biochemical testing requires two consecutive assessments (by the same method) made at any time before the institution of any new therapy.

Complete Remission (CR)

A treatment response where all of the following criteria are met:

  • < 5% plasma cells in the bone marrow (confirmation with repeat bone marrow biopsy not needed); and
  • Absence of extramedullary disease; and
  • No plasma cells in peripheral blood; and
  • Negative immunofixation on serum and urine samples.

If the serum and urine M-protein are not measurable (i.e., do not meet the following criteria at time of diagnosis):

  • Serum M-protein ≥ 1 g / dL
  • Urine M-protein ≥ 200 mg / 24 hours

then a normal serum free light chain (FLC) ratio is required in place of the M-protein criteria (provided the serum FLC assay showed an involved level > 10 mg / dL and an abnormal serum FLC ratio at diagnosis).

CR by biochemical testing requires two consecutive assessments (by the same method) made at any time before the institution of any new therapy.

Very Good Partial Response (VGPR)

A treatment response where all the following criteria are met:

  • Bone marrow plasma cells <5% (confirmation not required); and
  • No plasma cells in the peripheral blood; and
  • Absence of extramedullary disease; and
  • Serum and urine M-protein detectable by immunofixation but not on electrophoresis or a ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg / 24 hours.

If the serum and urine M-protein are not measurable (i.e., do not meet the following criteria at time of diagnosis):

  • Serum M-protein ≥ 1 g / dL
  • Urine M-protein ≥ 200 mg / 24 hours

then a ≥ 90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria (provided the serum FLC assay showed an involved FLC level > 10 mg / dL and an abnormal serum FLC ratio at diagnosis).

VGPR by biochemical testing requires two consecutive assessments (by the same method) made at any time before the institution of any new therapy.

Partial Response (PR)

A treatment response where all the following criteria are met:

  • 5% to 25% plasma cells in the bone marrow; and
  • 1% to 5% plasma cells in peripheral blood; and
  • ≥ 50% reduction in the size of extramedullary disease; and
  • ≥ 50% reduction in serum M-protein; and
  • ≥ 90% reduction in 24-hour urinary M-protein and < 200 mg / 24 hours.

If the serum and urine M-protein are not measurable (i.e., do not meet the following criteria at time of diagnosis):

  • Serum M-protein ≥ 1 g / dL
  • Urine M-protein ≥ 200 mg / 24 hours

then a ≥ 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria (provided the serum FLC assay showed an involved level > 10 mg / dL and an abnormal serum FLC ratio at diagnosis).

PR by biochemical testing requires two consecutive assessments (by the same method) made at any time before the institution of any new therapy.

Stable Disease (SD)

Does not meet the criteria for PR or PD.

Progressive Disease (PD)

Requires one or more of the following:

  • Increase of ≥ 25% from the lowest response value achieved in:
    • Bone marrow plasma cell percentage (in aspirate) or absolute percentage ≥ 10%; and / or
    • Serum M-component with an absolute increase ≥ 0.5 g / dL (or 5 g / L) (for progressive disease, serum M-component increases of ≥ 1 g / dL are sufficient if the starting M-component is ≥ 5 g / dL); and / or
    • Urine M-component with an absolute increase ≥ 200 mg / 24 hours; and / or
  • >5% absolute increase in peripheral blood plasma cells; and / or
  • Definite development of new bone lesions or extramedullary disease, or definite increase in the size of any existing bone lesions or extramedullary disease; and / or
  • Development of hypercalcemia (corrected serum calcium > 11.5 mg / dL or 2.65 mmol) that can be attributed solely to the PCL.

PD by biochemical testing requires two consecutive assessments (by the same method) made at any time before classification as disease progression, and / or the start of any new therapy.

Relapse from CR

Requires one or more of the following:

  • Development of ≥ 10% plasma cells in the bone marrow; and / or
  • Reappearance of peripheral blood plasma cells at any level; and / or
  • Appearance of any extramedullary disease; and / or
  • Reappearance of original serum or urine M-protein by immunofixation.

Relapse by biochemical testing requires two consecutive assessments (by the same method) made at any time before classification as relapse, and / or the start of any new therapy.

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
4/6/2020 Plasma Cell Leukemia Response Criteria Add Added guidance on Free Light Chain Ratios.
10/14/17 Plasma Cell Leukemia Response Criteria Add Version 1 of the Plasma Cell Leukemia Response Criteria section of the Forms Instructions Manual released.
Last modified: Oct 02, 2020

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