POEMS Response Criteria

General Reporting Guidelines

• Use the POEMS response criteria when determining the disease status for POEMS.
• 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.

*Urine Studies
In order to report a Complete Response (CR), urine studies MUST be performed and agree with the criteria provided. As long as the negative serum electrophoresis and immunofixation studies have been confirmed, only one set of negative urine studies needs to be documented to report CR.

!Confirmatory Assessments for POEMS
Questions often arise about how to report a disease response when the recipient meets all criteria for a disease response at a given timepoint (i.e., pre-infusion, 100-day date of contact, 6-month date of contact, etc.) and the confirmatory assessment is performed within the next timepoint. In this case, the disease response should be reported at the timepoint in which it was first observed (not the timepoint in which it was confirmed). Please note, this may require updating a previously submitted form.

*Urine Immunofixation and Electrophoresis
The sample for the urine immunofixation and electrophoresis criteria must be a 24-hour urine and not a random urine.

Hematologic Response

Complete Response (CR)

Requires all of the following:

• Serum and urine negative for monoclonal proteins by immunofixation
• Plasma cells in marrow < 5%
  

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

The method of the two consecutive assessments may be any of the biochemical tests (urine / serum testing) listed in the disease status criteria available in the manual. Though it is preferable the biochemical confirmatory testing include both urine & serum, this disease status does not required two consecutive assessments by each method.

*Serum or Urine Immunofixation: New monoclonal proteins
After treatment, a new monoclonal protein may be detected by serum or urine immunofixation (the monoclonal protein detected at diagnosis was not detected after treatment and different monoclonal protein was identified). In most cases, if a new monoclonal protein is detected by serum or urine immunofixation after treatment, it probably represents immune reconstitution and not disease. Consult with the transplant physician to determine if the new monoclonal protein is indicative of disease.

Very Good Partial Response (VGPR)

One or more of the following must be present:

• Serum M-protein detectable by immunofixation, but not on electrophoresis; or
• A ≥ 90% reduction in the serum M-protein as long as the serum M-protein was ≥ 0.5 g/dL at baseline
  

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

Partial Response (PR)

• A ≥ 50% reduction in the serum M-protein as long as the serum M-protein was ≥ 1.0 g/dL at baseline

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

No Response (NR)

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

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

Progressive Disease (PD)

• Requires a 25% increase from the lowest M-spike achieved with an absolute increase of > 0.5 g/dL

PD 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.

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
2/12/2024	POEMS Response Criteria	Add	Urine Immunofixation and Electrophoresis blue box added for clarification: Urine Immunofixation and Electrophoresis: The sample for the urine immunofixation and electrophoresis criteria must be a 24-hour urine and not a random urine.
5/18/2022	POEMS Response Criteria	Remove	POEMS Partial Response Criteria update to be more concise as the first bullet point was the same criteria for VGPR: One or more of the following must be present: Serum M-protein detectable by immunofixation A ≥ 50% reduction in the serum M-protein as long as the serum M-protein was ≥ 1.0 g/dL at baseline
10/2/2020	POEMS Response Criteria	Add	POEMS Response Criteria section of the Forms Instructions Manual released.

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