Q211-252: Disease Status at the Time of Evaluation for this Reporting Period

For questions 211-252, report values obtained at the last evaluation for this reporting period. If testing is performed multiple times during the reporting period, report the values obtained at the last evaluation in the reporting period.

Questions 211 – 213: Serum creatinine

Indicate whether the serum creatinine was Known or Unknown at the time of evaluation for this reporting period. If Known, report the laboratory value, unit of measure, and the upper limit of normal, as documented on the laboratory report. If Unknown, continue with question 214.

Questions 214 – 215: Serum monoclonal protein (M-spike) (only from electrophoresis)

Monoclonal gammopathy is defined as the increased production of abnormal immunoglobulins. The abnormal protein produced is called paraprotein or M-protein. Indicate whether the serum monoclonal immunoglobulin was Known or Unknown at the time of evaluation for this reporting period. If Known, report the value and unit of measure documented on the laboratory report. If Unknown or Not applicable, continue with question 216. Report Not applicable for recipients with non-secretory myeloma.

Do not report immunofixation results here.

Questions 216 – 217: Serum immunofixation

Indicate whether the serum paraprotein was detected on serum immunofixation. If detected, report Known and indicate the M-spike type, including both the heavy and light chain distinctions. The involved heavy chain and light chain can be identified but not quantified using this test. If multiple M-spike types are involved, select each that are present (e.g. IgG Kappa and IgA Lambda). Report No bands present if serum immunofixation was performed but no paraprotein was identified.

If Unknown or Not applicable, continue with question 220. Report Not applicable for recipients with non-secretory myeloma.

Question 218: Original monoclonal bands

Indicate Yes if the original monoclonal band was present or No if it was not present.

Question 219: New monoclonal (or oligoclonal) bands

Indicate Yes if a new monoclonal band (or oligoclonal) was present or No if it was not present

Questions 220 – 222: Serum free light chains – κ (kappa)

Indicate whether the serum κ (kappa) free light chain level at the time of evaluation for this reporting period is Known or Unknown. This value should reflect the quantity of serum free light chains, not a quantification of total light chains. If Known, report the value, unit of measure, and upper limit of normal, as documented on the laboratory report. If Unknown or Not applicable, continue with question 223. Report Not applicable for recipients with non-secretory myeloma.

Questions 223 – 225: Serum free light chains – λ (lambda):

Indicate whether the serum λ (lambda) free light chain level at the time of evaluation for this reporting period is Known or Unknown. This value should reflect the quantity of serum free light chains, not a quantification of total light chains. If Known, report the value, unit of measure, and upper limit of normal, as documented on the laboratory report. If Unknown or Not applicable, continue with question 226. Report Not applicable for recipients with non-secretory myeloma.

Questions 226 – 227: Total urine protein in 24 hours

Indicate whether the amount of urinary protein at the time of evaluation for this reporting period was Known or Unknown. The value reported here should be based on a 24-hour urine collection. If Known, report the laboratory value and unit of measure documented on the laboratory report7. If Unknown or Not applicable, continue with question 228. Report Not applicable for recipients with non-secretory myeloma.

Questions 228 – 229: Urine albumin / creatinine ratio

Indicate whether the urinary albumin / creatinine ratio was Known or Unknown at the time of evaluation for this reporting period. The value reported here should be based on a 24-hour urine collection. If Known, report the laboratory value and unit of measure documented on the laboratory report. If Unknown, continue with question 230.

Questions 230 – 231: Urine protein / creatinine ratio

Indicate whether the urinary protein / creatinine ratio was Known or Unknown at the time of evaluation for this reporting period. The value reported here should be based on a 24-hour urine collection. If Known, report the laboratory value and unit of measure documented on the laboratory report. If Unknown, continue with question 232.

Questions 232 – 233: Urinary monoclonal protein (M-spike)

Indicate whether the amount of urinary monoclonal protein was Known or Unknown at the time of evaluation for this reporting period. The value reported here should be based on a 24-hour urine collection. If Known, report the laboratory value and unit of measure documented on the laboratory report. If Unknown or Not applicable, continue with question 234. Report Not applicable for recipients with non-secretory myeloma.

Question 234: Urinary immunofixation

Urine immunofixation is a laboratory technique that detects and types monoclonal antibodies or immunoglobulins in the urine. Indicate if the results of urinary immunofixation at the time of evaluation for this reporting period is Known or Unknown. If Unknown or Not applicable, continue with question 237. Report Not applicable for recipients with non-secretory myeloma.

Question 235: Original monoclonal bands

Indicate Yes if the original monoclonal band was present or No if it was not present.

Question 236: New monoclonal (or oligoclonal) bands

Indicate Yes if a new monoclonal (or oligoclonal) band was present or No if it was not present.

Questions 237 – 238: Plasma cells in bone marrow aspirate by flow cytometry

Indicate whether the percentage of plasma cells in the bone marrow aspirate assessed by flow cytometry at the time of evaluation for this reporting period is Known or Unknown. If Known, report the percentage of plasma cells in the bone marrow aspirate documented on the pathology report. If Unknown, continue with question 239.

Questions 239 – 240: Plasma cells in bone marrow aspirate by morphologic assessment

*Under normal circumstances, the marrow aspirate is used to obtain the differential cell count, review morphology of the cells, and perform cytogenetic studies, flow cytometry, etc. The biopsy is obtained to evaluate the overall cellularity of the marrow. In the case of myeloma, the marrow plasma cells tend to be a patchy infiltrate rather than a diffuse infiltrate as in the case of acute leukemia. Therefore, it is possible that the plasma cell numbers may vary between the aspirate and biopsy. For this reason, this form captures the plasma cell percentage by both methods in questions 239-242.

*If the bone marrow pathology report states a range for plasma cells, enter the average of the range rounded to the nearest whole number (e.g., if 0-5%, enter 3%).
If the report states > 90% plasma cells, enter 91% on the form.
If the report states a marrow packed with plasma cells or sheets of plasma cells, report 99% on the form.
If the report states < 5% plasma cells, enter 4% on the form.

Indicate whether the percentage of plasma cells in the bone marrow aspirate was Known or Unknown by morphologic assessment at the time of evaluation for this reporting period. If Known, report the percentage of plasma cells in the bone marrow aspirate documented on the pathology report. If Unknown, continue with question 241.

Questions 241 – 242: Plasma cells in bone marrow biopsy

Indicate whether the percentage of plasma cells in the bone marrow biopsy at the time of evaluation for this reporting period is Known or Unknown. If Known, report the percentage of plasma cells in the bone marrow biopsy documented on the pathology report. If Unknown, continue with question 243.

Question 243: Did the recipient receive dialysis?

Indicate if the recipient received dialysis during this reporting period. If the recipient received dialysis at any point, report Yes. If the recipient did not receive dialysis during the reporting period, report No and continue with question 246.

Questions 244 – 245: Date of dialysis

Indicate if the date the recipient started dialysis was Known or Unknown. If Known, report the date that dialysis began. If Unknown, continue with question 246.

Question 246: Was a PET / CT scan performed?

A PET / CT combines the results of the PET (Positron Emission Tomography) scan along with the results of a CT (Computed Tomography) scan. If a PET / CT scan was performed at the time of evaluation for this reporting period, indicate Yes. If a PET / CT scan was not performed, select No and continue with question 251.

Questions 247 – 248: Was the PET / CT scan positive for myeloma involvement at any disease site?

Indicate if the PET / CT scan was positive for myeloma involvement at any disease site. If positive at any site, report Yes and specify which area(s) show involvement in. If negative, report No and continue with question 251.

Questions 249 – 250: Date of PET / CT scan

Indicate if the date of the PET / CT scan was Known or Unknown at the time of evaluation for this reporting period. If Known, report the assessment date. If Unknown, continue with question 251.

Question 251: What is the hematologic disease status at the time of the most current evaluation?

!This question will be answered for recipients whose primary disease for infusion includes all plasma cell disorders except amyloidosis. If amyloidosis was reported as the primary disease for infusion (question 1), skip questions 251-252 and continue with question 253.

Report the disease status at the time of evaluation for this reporting period. See the Multiple Myeloma Response Criteria section for multiple myeloma and solitary plasmacytoma disease status definitions. See Plasma Cell Leukemia Response Criteria for plasma cell leukemia disease status definitions.

If the disease response prior to transplant is unknown, select Unknown and continue with question 253.

The center does not need to repeat all disease-specific assessments (biopsies, scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression.

This question will not be enabled if the primary disease for transplant is monoclonal gammopathy of renal significance (MGRS).

Question 252: Date hematologic disease status assessed

Enter the date of the most recent disease evaluation. Report the date the blood/urine was collected for the laboratory evaluations (e.g., SPEP/UPEP, serum/urine immunofixation) or report the date the bone marrow was collected for pathological evaluation. A PET scan may be used if a PET scan was previously obtained and only in limited circumstances (e.g., plasmacytomas, lytic lesions).

If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
.	.	.	.	.

Copyright © 2004-2024 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.