For questions 188-255, report values obtained at the last evaluation prior to the start of the preparative regimen / infusion. If testing is performed multiple times prior to the start of the preparative regimen, report the last test before the start of the preparative regimen.

Questions 188-189: Serum β2 microglobulin:

An elevated serum β2 microglobulin protein at the last evaluation prior to the start of the preparative regimen may indicate a poorer prognosis. If this value is “known,” report the value and unit of measure documented on the laboratory report in question 189. If “unknown,” continue with question 190.

Question 190: Plasma cells in blood by flow cytometry:

Indicate if the value of plasma cells in the blood was assessed by flow cytometry at the last evaluation prior to the start of the preparative regimen. Report if the value of plasma cells were “known” or “unknown.” If “known,” go to question 191, if “unknown,” continue with question 193.

Questions 191-192: Value of plasma cells in blood:

Indicate the percentage and absolute value of plasma cells detected in the blood by flow cytometry at the last evaluation prior to the start of the preparative regimen. If only the percentage of plasma cells is available, multiply the percentage of plasma cells by the white blood cell count (WBC) to determine the absolute number of plasma cells.

Question 192 is disabled and should not be answered. This question will be removed when the form is next revised.

Question 193: Plasma cells in blood by morphologic assessment

Indicate if the number of plasma cells in the peripheral blood was assessed by morphologic assessment at the last evaluation prior to the start of the preparative regimen. This would be found on the CBC differential. Report if the value of plasma cells were “known” or “unknown.” If “known,” go to question 194, if “unknown,” continue with question 196.

Questions 194-195: Value of plasma cells in blood by morphologic assessment:

Indicate the percentage and absolute value of plasma cells detected in the blood by morphologic assessment at the last evaluation prior to the start of the preparative regimen. If only the percentage of plasma cells is available, multiply the percentage of plasma cells by the white blood cell count (WBC) to determine the absolute number of plasma cells.

Questions 196-197: Serum albumin:

Indicate whether the serum albumin at the last evaluation prior to the start of the preparative regimen is “known” or “unknown.” If “known,” report the value and unit of measure documented on the laboratory report in question 197. If “unknown,” continue with question 198.

Questions 198-199: 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 quantity serum monoclonal immunoglobulin at the last evaluation prior to the start of the preparative regimen is “known” or “unknown.” If “known,” report the value and unit of measure documented on the laboratory report in question 199. If “unknown,” continue with question 200. Report “not applicable” for recipients with non-secretory myeloma.

Question 200: Serum immunofixation:

Serum immunofixation is a laboratory technique that detects and types monoclonal antibodies or immunoglobulins in the blood. If “known,” continue with question 201. If “unknown” or “not applicable,” continue with question 203. Report “not applicable” for recipients with non-secretory myeloma.

Question 201: Original monoclonal bands:

Indicate “yes” if the original monoclonal band was present or “no” if it was not present.

Question 202: New monoclonal (or oligoclonal) bands:

Indicate “yes” if a new monoclonal band (or oligoclonal) was present or “no” if it was not present.

Questions 203-204: Serum free light chains – κ (kappa):

Indicate whether the serum κ (kappa) free light chain level at the last evaluation prior to the start of the preparative regimen 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 and unit of measure documented on the laboratory report in question 204 and continue with question 205. If “unknown” or “not applicable,” continue with question 206. Report “not applicable” for recipients with non-secretory myeloma.

Question 205: Upper limit of normal for κ free light chain:

Indicate the upper limit of normal for κ (kappa) free light chains value and the unit of measure found on the laboratory report.

Questions 206-207: Serum free light chains – λ (lambda):

Indicate whether the serum λ (lambda) free light chain level at the last evaluation prior to the start of the preparative regimen is “known” or “unknown.” This value should reflect the quantity of serum free light chains, not a quantification of total light chains. If “known,” use question 207 to record the value and unit of measure documented on the laboratory report and continue with question 208. If “unknown” or “not applicable,” continue with question 209. Report “not applicable” for recipients with non-secretory myeloma.

Question 208: Upper limit of normal for λ free light chains:

Indicate the upper limit of normal for λ (lambda) free light chains value and the unit of measure found on the laboratory report.

Questions 209-210: Urinary monoclonal protein (M-spike) / 24 hours:

Indicate whether the amount of urinary monoclonal protein at the last evaluation prior to the start of the preparative regimen is “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 report in question 210. If “unknown” or “not applicable,” continue with question 211. Report “not applicable” for recipients with non-secretory myeloma. Do not report immunofixation results here.

Example:
(total in g/dL of monoclonal protein) x (total urine volume) = urinary M-protein/24 hours
(0.145 g/dL of monoclonal protein) x (1500 mL total urine) x (1 dL/100 mL)= 2.175 g/24 hours

Question 211: 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 last evaluation prior to the start of the preparative regimen are “known” or “unknown.” If “known,” continue with question 212. If “unknown” or “not applicable,” continue with question 214. Report “not applicable” for recipients with non-secretory myeloma.

Question 212: Original monoclonal bands:

Indicate “yes” if the original monoclonal band was present or “no” if it was not present.

Question 213: New monoclonal (or oligoclonal) bands:

Indicate “yes” if a new monoclonal (or oligoclonal) band was present or “no” if it was not present.

Questions 214-215: Total urine protein in 24 hours:

Indicate whether the amount of urinary protein at the last evaluation prior to the start of the preparative regimen 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 report in question 215. If “unknown” or “not applicable,” continue with question 216. Report “not applicable” for recipients with non-secretory myeloma.

Questions 216-217: Urine albumin / creatinine ratio:

Indicate whether the urinary albumin / creatinine ratio was “known” or “unknown” at the last evaluation prior to the start of the preparative regimen. 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 in question 217. If “unknown,” continue with question 218. This question is only required if the primary disease (question 1) is MGRS or Amyloidosis or if there is evidence / history of (question 2) MGRS or Amyloidosis.

Questions 218-219: Urine protein / creatinine ratio:

Indicate whether the urinary protein / creatinine ratio was “known” or “unknown” at the last evaluation prior to the start of the preparative regimen. 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 in question 219. If “unknown,” continue with question 220. This question is only required if the primary disease (question 1) is MGRS or Amyloidosis or if there is evidence / history of (question 2) MGRS or Amyloidosis.

Question 220: Was minimal residual disease (MRD) assessed during the pre-HCT or pre-infusion evaluation? (report only bone marrow or blood results):

Minimal residual disease (MRD), is an indicator of increased risk for disease relapse and / or progression. MRD can be assessed by different methods including, but not limited to, next generation sequencing (NGS), Sanger sequencing, polymerase chain reaction (PCR) testing, chromosomal / genomic microarray analysis, fluorescence in situ hybridization (FISH), karyotyping, or flow cytometry.

Indicate if MRD was performed by next generation sequencing (NGS) or next generation flow (NGF) at the last evaluation prior to the start of the preparative regimen.

If any MRD testing was performed for patients with myeloma, answer question 220 as “yes” and continue with question 221. If no MRD testing methods were performed, report “no” and continue with question 229.

Questions 221-222: Next generation sequencing (NGS):

Indicate whether the MRD result at the last evaluation prior to the start of the preparative regimen is “positive,” “negative,” or “not done” by NGS testing. If “positive,” report the sample source (blood or bone marrow) in question 222 and continue with question 223. If “negative” or “not done,” continue with question 225.

Questions 223-224: Indicate the sensitivity of the next generation sequencing (NGS) testing:

Indicate the testing sensitivity of the NGS testing performed at the last evaluation prior to the start of the preparative regimen. If the specificity is not listed in this section, report “other” and specify the sensitivity as documented on the laboratory report in question 224.

Questions 225-226: Next generation flow (NGF):

Indicate whether the MRD result at the last evaluation prior to the start of the preparative regimen is “positive,” “negative,” or “not done” by NGF testing.

  • If “positive,” report the sample source (blood or bone marrow) in question 226 and continue with question 229
  • If “negative” report the sample source (blood or bone marrow) in question 226 and continue with question 227
  • If “not done,” continue with question 229

Questions 227-228: Indicate the sensitivity of the next generation flow (NGF) testing:

Indicate the testing sensitivity of the NGF testing performed at the last evaluation prior to the start of the preparative regimen.

NGF testing is used to identify minimal residual disease (MRD) in patients with multiple myeloma. Some NGF reports include a “level of detection” rather than a “level of sensitivity.” In these cases, the “level of sensitivity” can be derived from the level of detection. Please refer to the report and example below for further instruction.

Example:

  • Level of Detection: 0.001 is equal to:
  • Level of Sensitivity: 10 -5 (1/100,000 cells) and should be reported in question 227)

If the specificity is not listed in this section, report “other” and specify the sensitivity as documented on the laboratory report in question 228.

Questions 229-230: 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 last evaluation prior to the start of the preparative regimen is “known” or “unknown.” If “known,” report the percentage of plasma cells in the bone marrow aspirate documented on the pathology report in question 230. If “unknown,” continue with question 231.

Questions 231-232: Plasma cells in bone marrow aspirate by morphologic assessment:

Indicate whether the percentage of plasma cells in the bone marrow aspirate was “known” or “unknown” by morphologic assessment at the last evaluation prior to the start of the preparative regimen. If “known,” report the percentage of plasma cells in the bone marrow aspirate documented on the pathology report in question 232. If “unknown,” continue with question 233.

Questions 233-234: Plasma cells in bone marrow biopsy:

Indicate whether the percentage of plasma cells in the bone marrow biopsy at the last evaluation prior to the start of the preparative regimen is “known” or “unknown.” If “known,” report the percentage of plasma cells in the bone marrow biopsy in question 234. If “unknown,” continue with question 235.

Question 235: Were cytogenetics tested (karyotyping or FISH)?

Cytogenetic analysis is the study of chromosomes. Cytogenetic assessment involves testing blood or bone marrow for the presence of a known chromosomal abnormality which reflects the recipient’s disease. Testing methods you may see include conventional chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For more information about cytogenetic testing and terminology, see Appendix C, Cytogenetic Assessments.

Karyotyping is performed by culturing cells (growing cells under controlled conditions) until they reach the dividing phase. Techniques are then performed to visualize the chromosomes during cell division so that various bands and reconfigurations can be seen. Banding pattern differentiation and chromosomal reconfiguration demonstrate evidence of disease.

FISH is a sensitive technique that assesses a large number of cells. This technique uses special probes that recognize and bind to fragments of DNA. These probes are mixed with cells from the recipient’s blood or bone marrow. A fluorescent “tag” is then used to visualize the binding of the probe to the diseased cells.

Indicate whether cytogenetic studies were tested at the last evaluation prior to the start of the preparative regimen. If cytogenetic studies were obtained, check “yes” and go to question 236. If cytogenetic studies were not obtained, or it is unknown whether chromosome studies were performed, indicate “no” or “unknown” respectively and go to question 248.

Question 236: Were cytogenetics tested via FISH?

FISH, fluorescence in situ hybridization, is a sensitive technique that assesses a large number of cells. This technique utilizes special probes that recognize and bind to fragments of DNA commonly found in plasma cell disorders. These probes are mixed with cells from the recipient’s blood. A fluorescent “tag” is then used to visualize the binding of the probe to the diseased cells.

Indicate if FISH studies were obtained at the last evaluation prior to the start of the preparative regimen. If FISH studies were obtained, select “yes” and continue with question 237.

If no FISH studies were obtained or it is unknown if FISH studies were performed, select “no” or “unknown” and continue with question 242.

Question 237: Results of test:

If FISH studies identified abnormalities, indicate “abnormalities identified” and continue with question 238.

If there were no abnormalities identified, indicate this and continue with question 241.

Questions 238-240: Specify cytogenetic abnormalities (FISH):

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable in question 238, then continue with question 239.

Specify each abnormality detected by FISH at the last evaluation prior to the start of the preparative regimen in question 239-240.

If a clonal abnormality is detected, but not listed as an option in question 239, select “other abnormality” and specify the abnormality in question 240. If multiple “Other abnormalities” were detected, report “see attachment” in question 240 and attach the final report(s) for any other abnormalities detected. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 241: Was documentation submitted to the CIBMTR (e.g., FISH report)?

Indicate if a FISH testing report is attached to support the cytogenetic findings reported in questions 238-240. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 242: Were cytogenetics tested via karyotyping?

Cytogenetics is the study of chromosomes. Cytogenetic assessment involves testing blood or bone marrow for the presence of a known chromosomal abnormality that reflects the recipient’s disease. Cytogenetics may also be referred to as karyotyping or g-banding.

Indicate if cytogenetic studies were obtained by karyotyping at the last evaluation prior to the start of the preparative regimen. If karyotyping studies were obtained, select “yes” and continue with question 243.

If no karyotyping studies were obtained, select “no” and continue with question 248.

Question 243: Results of test:

If karyotyping studies identified abnormalities, indicate “abnormalities identified” and continue with question 244.

If karyotyping studies yielded no evaluable metaphases or there were no abnormalities identified, indicate this and continue with question 247.

Questions 244-246: Specify cytogenetic abnormalities (karyotyping):

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable in question 244, then continue with question 245.

Specify each abnormality detected by karyotyping at the last evaluation prior to the start of the preparative regimen in question 245-246.

If a clonal abnormality is detected, but not listed as an option in question 245, select “other abnormality” and specify the abnormality in question 246. If multiple “Other abnormalities” were detected, report “see attachment” in question 246 and attach the final report(s) for any other abnormalities detected. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 247: Was documentation submitted to the CIBMTR (e.g., karyotyping report)?

Indicate if a karyotyping report is attached to support the cytogenetic findings reported in questions 245-246. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.

Question 248: Did the recipient receive dialysis?

Indicate if the recipient received dialysis prior to the start of the preparative regimen. If the recipient was on dialysis at any point within approximately 30 days prior to the start of the preparative regimen, report “yes” and continue with question 249. If the recipient did not receive dialysis within approximately 30 days prior to the start of the preparative regimen, report “no” and continue with question 256.

Questions 249-250: Date of dialysis:

Indicate if the date the recipient received dialysis was “known” or “unknown.” If “known,” report the date that dialysis began in question 250.. If “unknown,” continue with question 251.

Question 251: 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 last evaluation prior to the start of the p reparative regimen, indicate “yes” and continue with question 252. If a PET / CT scan was not performed, select “no” and continue with question 256.

Questions 252-253: 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” for question 252 and specify which area(s) show involvement in question 253. If negative, report “no” and continue with question 254.

Questions 254-255: Date of PET / CT scan:

Indicate if the date of the PET / CT scan was “known” or “unknown” at the last evaluation prior to the start of the preparative regimen. If “known,” report the assessment date in question 255. If “unknown,” continue with question 256.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Dec 22, 2020

Need more help with this?
Don’t hesitate to contact us here.

Was this helpful?

Yes No
You indicated this topic was not helpful to you ...
Could you please leave a comment telling us why? Thank you!
Thanks for your feedback.