2021 Manual Updates

January 2021
March 2021
April 2021
May 2021
June 2021
July 2021
August 2021
September 2021
October 2021
November 2021

Updates made during the current calendar year are included below. For updates prior to 2021, click on the subtopic corresponding to the year of interest. If you need to reference an archived manual section for a retired form, please refer to the Retired Forms Manuals webpage.

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November 2021

11/29/2021	Appendix D: How to Distinguish Infusion Types	Modify	Updated to include gene therapy information
11/19/2021	2118: LYM Post-Infusion Data	Modify	The instructions for reporting the current disease status by PET for question 89 were updated: Indicate the current disease status, based on radiographic criteria, using the international working group criteria provided in LYM Response Criteria section of the Forms Instruction Manual. The current disease status by PET should reflect the most recent disease CT evaluations if assessments were performed during the reporting period. However, the center does not need to repeat all disease-specific assessments (i.e., CT (radiographic) or PET scans) each reporting period in order to complete current disease status data fields. For instance, once a requirement meets the criteria for Complete Remission (CR), the center can continue reporting CR (based on labs / clinical assessments) until there is evidence of relapse / progression. If a disease-specific assessment did not occur during this time period (i.e., a PET or CT scan), report the date of any disease related assessment (i.e., clinical assessments, labs, etc.) as the date assessed (Q88 or Q90) regardless of what the parent question states about the specific CT (radiographic) or PET criteria. The intent of this question is to capture the current disease status based on the assessments available. Report “Not assessed” and go to question 89 %(color-red)only when if the recipient had relapses or progresses, therapy for relapse / progressive disease is given, and an additional CT scan was not performed post therapy to assess their disease status. Example 1. On the contact date for the Day 100 reporting period, a recipient progressed by CT. The recipient did not receive therapy and was only assessed by physician exams in the 6-month reporting period – no additional PET scans were performed. Day 100 Reporting Period: The current disease status should be reported as “PD” with the assessment date of the PET performed on the contact date 6-Month Reporting Period: The current disease status should be reported as “PD” with the assessment date of the most recent physician’s exam performed in the reporting period. Example 2. On the contact date for the Day 100 reporting period, a recipient progressed by PET. The recipient received therapy; however, a PET scan was not performed in the 6-month reporting period – only physician exams and labs were performed. Day 100 Reporting Period: The current disease status should be reported as “PD” with the assessment date of the PET performed on the contact date 6 Month Reporting Period: The current disease status should be reported as “Not assessed” since the disease status was not re-assessed by a PET scan after receiving therapy for progressive disease. The center does not need to repeat all disease-specific assessments (i.e., CT (radiographic) or PET scans) 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. If a disease-specific assessment did not occur during this time period, please report the date of any disease related assessment ( e.g. clinical assessments, labs, etc.) as the date assessed (Q88 or Q90) regardless of what the parent question states about the specific CT (radiographic) or PET criteria.
11/19/2021	2118: LYM Post-Infusion Data	Modify	The instructions for reporting the current disease status by CT were updated for question 87: Indicate the current disease status, based on radiographic criteria, using the international working group criteria provided in LYM Response Criteria section of the Forms Instruction Manual. The current disease status by CT should reflect the most recent disease CT evaluations if assessments were performed during the reporting period. However, the center does not need to repeat all disease-specific assessments (i.e., CT (radiographic) or PET scans) each reporting period in order to complete current disease status data fields. For instance, once a requirement meets the criteria for Complete Remission (CR), the center can continue reporting CR (based on labs / clinical assessments) until there is evidence of relapse / progression. If a disease-specific assessment did not occur during this time period (i.e., a PET or CT scan), report the date of any disease related assessment (i.e., clinical assessments, labs, etc.) as the date assessed (Q88 or Q90) regardless of what the parent question states about the specific CT (radiographic) or PET criteria. The intent of this question is to capture the current disease status based on the assessments available. Report “Not assessed” and go to question 89 %(color-red)only when if the recipient had relapses or progresses, therapy for relapse / progressive disease is given, and an additional CT scan was not performed post therapy to assess their disease status. Example 1. On the contact date for the Day 100 reporting period, a recipient progressed by CT. The recipient did not receive therapy and was only assessed by physician exams in the 6-month reporting period – no additional CT scans were performed. Day 100 Reporting Period: The current disease status should be reported as “PD” with the assessment date of the CT performed on the contact date 6-Month Reporting Period: The current disease status should be reported as “PD” with the assessment date of the most recent physician’s exam performed in the reporting period. Example 2. On the contact date for the Day 100 reporting period, a recipient progressed by CT. The recipient received therapy; however, a CT scan was not performed in the %(color-red)6-month reporting period – only physician exams and labs were performed. Day 100 Reporting Period: The current disease status should be reported as “PD” with the assessment date of the CT performed on the contact date 6 Month Reporting Period: The current disease status should be reported as “Not assessed” since the disease status was not re-assessed by a CT scan after receiving therapy for progressive disease. The center does not need to repeat all disease-specific assessments (i.e., CT (radiographic) or PET scans) 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. If a disease-specific assessment did not occur during this time period, please report the date of any disease related assessment ( e.g. clinical assessments, labs, etc.) as the date assessed (Q88 or Q90) regardless of what the parent question states about the specific CT (radiographic) or PET criteria.
11/19/2021	2018: LYM Pre-Infusion	Modify	Updated the reporting instructions for when questions 224 – 233 will come due (Disease Assessment at the Failure of the 1st Line of Therapy blue box added): Disease Assessments at the Failure of the 1st Line of Therapy (DLBCL only) The Disease Assessment at the Failure of the 1st Line of Therapy (DLBCL only) section will only be completed if the primary disease for infusion is de novo diffuse large b-cell lymphoma (DLBCL) or untreated lymphoma which transformed DLBCL. This include the following subtypes: cell of origin unknown, germinal center B-cell type, and activated B-cell type (non-GCB). If this is a report of a subsequent infusion and: 1. The prior infusion was an autologous HCT that was not reported, complete questions 224 – 233; or 2. A prior Lymphoma Pre-Infusion (2018) form was not completed, complete question 224 – 233; or 3. A prior Lymphoma Pre-Infusion (2018) form was completed, skip to question 234 Questions 224-233 will only be answered if the primary disease was reported as diffuse large B-cell lymphoma (DLBCL) either at transformation (question 84) or at diagnosis (question 1) if no transformation occurred. This includes the following DLBCL subtypes: cell of origin unknown, germinal center B-cell type, and activated B-cell type (non-GCB). If the recipient’s primary disease was not DLBCL, skip questions 224-233 and go to question 234.
11/19/2021	2018: LYM Pre-Infusion	Modify	The instructions for Q222 – 223 were updated: Refer to the international working group criteria provided in LYM Response Criteria section of the Forms Instructions Manual for more information on how to determine recurrence / progression of disease. Report “Yes” if the recipient met the relapse / progression criteria (radiographic or metabolic) or if relapse / progression was detected based on clinical evidence (i.e., palpable nodes detected on the physician’s exam, abnormal labs, etc.) for relapse after starting this line of therapy and prior to starting a subsequent line of therapy. If “Yes” is reported, indicate the date of relapse / progression in question 223. If the date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.
11/19/2021	2018: LYM Pre-Infusion	Add	The instructions for question 219 were updated: Indicate the best response to the line of therapy by PET using the international working group metabolic criteria provided in LYM Response Criteria section of the Forms Instruction Manual. Report “Not assessed” if a PET scan was not performed after the line of therapy being reported and prior to the initiation of any new therapy.
11/19/2021	2018: LYM Pre-Infusion	Modify	The instructions for question 217 were updated: Indicate the best response to the line of therapy by CT using the international working group radiographic criteria provided in LYM Response Criteria section of the Forms Instruction Manual. If the recipient had palpable disease on a physical exam, those results can be reported in the CT (radiographic) criteria. Report “Not assessed” if no applicable assessments were a CT was not performed after the line of therapy being reported and prior the initiation of any new therapy.
11/19/2021	2018: LYM Pre-Infusion	Add	The Disease Assessments at Transformation blue box was added above question 82 for clarification: Disease Assessments at Transformation If this a report of a subsequent infusion and: 1. The prior infusion was an autologous transplant that was not reported, and a transformation occurred at any time between diagnosis and the current infusion, complete the Disease Assessments at Transformation section; or 2. A prior Lymphoma Pre-Infusion (2018) form was not completed, and a transformation occurred at any time between diagnosis and the current infusion, complete the Disease Assessments at Transformation section; or 3. A prior Lymphoma Pre-Infusion (2018) form was completed, and the transformation was previously reported, skip the Disease Assessments at Transformation section
11/19/2021	LYM Response Criteria	Add	Blue instructional box on how to report the disease status on the TED forms added.
11/19/2021	2402: Disease Classification	Add	Clarification added to question 394 to remind negative BM is not required to report CR using metabolic criteria: If metabolic criteria are used to determine the pre-HCT disease status, per the IWG criteria, normal morphology of the bone marrow is not required for reporting a complete remission

October 2021

10/29/2021	2402: Disease Classification	Modify	Due to form validation changes, updated the instructions for when the percentage of plasma cells or absolute number of plasma cells in the blood is needs to be reported for questions 421 – 423: Indicate if plasma cells in the peripheral blood by morphologic assessment was “known” or “unknown” at the time of diagnosis. If “known,” report the percentage of plasma cells detected in the blood by morphologic assessment documented on the laboratory report in question 422 and / or the absolute number documented on the laboratory report in question 423.
10/29/2021	2402: Disease Classification	Add	The hereditary diffuse leukoencephalopathy red warning box was added above Q498 – 499: Hereditary diffuse leukoencephalopathy (HDLS): If the primary disease for infusion is HDLS, select Other Inherited Metabolic Disorder as the classification and specify ‘hereditary diffuse leukoencephalopathy (HDLS).’ In addition, all recipients whose primary disease is reported as a ‘leukodystrophy’ (listed under Inherited Disorders of Metabolism) are required to complete Pre-Infusion Leukodystrophies (2037) and Post-Infusion Leukodystrophies (2137) forms. For recipients where the classification is ‘hereditary diffuse leukoencephalopathy (HDLS),’ submit a ticket through CIBMTR Customer Support to request the Pre-Infusion Leukodystrophies (2037) and Post-Infusion Leukodystrophies (2137) forms come due. With the Summer 2022 release, the Disease Classification (2402) form will be updated with an explicit option for this disease and the 2037 / 2137 forms will automatically come due.
10/27/2021	4100: Cellular Therapy Essential Data Follow-Up	Modify	Added the commercially available product names ‘Breyanzi’ and ‘Abecma’ to the red warning box below question 148: This question will enable only if the commercially available product ‘Kymriah’, ‘Breyanzi’, or ‘Abecma’ is selected in question 1 and can only be completed on the 100 day and 6 month follow-up forms.
10/13/2021	2402: Disease Classification	Modify	The response criteria for severe / very severe status for aplastic criteria was updated to be consistent with the current criteria in question 446 – 448: Indicate the aplastic anemia classification of the primary disease for infusion. If any of the following classifications are selected: Acquired AA, not otherwise specified (301) Acquired AA secondary to chemotherapy (313) Acquired AA secondary to hepatitis (302) (any form of hepatitis) Acquired AA secondary to immunotherapy or immune effector cell therapy (314) Acquired AA secondary to toxin / other drug (303) then, specify the severity in question 447 as either Severe / Very Severe or Not Severe at the time of diagnosis using the following criteria: Platelets < 10,000 or platelet transfusion to maintain platelets ≥ 10,000 Hemoglobin < 10 g / dL or red blood cell transfusions to maintain hemoglobin > 7 g / dL Absolute neutrophil count (ANC) < 1000 or on G-CSF to maintain ANC ≥ 1000 Absolute reticulocyte count (ARC) < 20 × 109/L Severe / Very Severe Requires two or more of the following1: Bone marrow cellularity < 25 % (or 25 % to 50 % if < 30 % of residual cells are hematopoietic) At least two of the following: Peripheral blood absolute neutrophil count (ANC) < 500 / µL (<0.5 x 109/L) Peripheral blood platelet count < 20,000 / µL Peripheral blood reticulocyte count < 20,000 / µL
10/13/2021	2402: Disease Classification	Add	Serum β2 microglobulin and albumin blue info box added above question 411: Serum β2 microglobulin and albumin: If this form is being completed for a subsequent infusion, report the serum β2 microglobulin and albumin at the time of the multiple myeloma diagnosis, and not at the time of relapse or progression.
10/12/2021	2402: Disease Classification	Add	ISS and R-ISS blue info box added above question 415: I.S.S and R-I.S.S. staging: If this form is being completed for a subsequent infusion, report the I.S.S. and R-I.S.S. staging at the time of the multiple myeloma diagnosis, and not at the time of relapse or progression.
10/12/2021	2402: Disease Classification	Modify	Updated the Assessments at Diagnosis blue box above question 411 for clarification when multiple assessments are performed prior to the start of therapy: Questions 411 – 439 refer to the labs and assessments performed at diagnosis of the primary disease for transplant. If testing was performed multiple times prior to the start of treatment, report the most recent assessment before the start of therapy.

September 2021

9/15/2021	Cellular Therapy Manuals	Add	Added statement for REMS reporting: REMS reporting: infusions can be reported without research consent if the center is utilizing CIBMTR to support their REMS reporting needs in meeting the requirements for the commercially available CAR-T products.
9/1/2021	2450: Post-TED	Modify	The instructions on how to report the assessment date when the best response is NCR for molecular, flow cytometry, FISH, karyotype, and radiological assessments were updated for clarification. Review the manual updates section of the Disease Assessment at the Time of Best Response to HCT for information regarding the specific changes.
9/1/2021	2450: Post-TED	Remove	The instructions on when to report the overall grade as “not applicable” (Q22 and 29) was updated to reflect how isolated transaminitis should not be reported as acute GVHD to be consistent with changes made on 7/23/2021. If acute GVHD was present, but the grade at diagnosis was not documented and it cannot be determined from the grading and staging table, report Not applicable. Examples may include: Only elevated liver function tests without increased bilirubin Any other organ involvement without skin, liver, or gut symptoms attributable to GVHD Lower intestinal tract involvement where the stage cannot be determined in select scenarios (see lower intestinal tract involvement description below)

August 2021

8/12/2021	2450: Post-TED	Remove	The instructions on how to report the “other” organ staging were updated to be consistent with the changes made on 7/23/2021 regarding reporting isolated transaminitis: _Indicate whether acute GVHD affected an organ other than skin, upper GI, lower GI, or liver manifesting with hyperbilirubinemia. This includes transaminitis attributed to acute GVHD. Report only other organ involvement at the time of acute GVHD diagnosis or flare in the reporting period. Do not report symptoms ongoing but not attributed to acute GVHD at the time of acute GVHD diagnosis or flare. Specify the other organ system involvement in question 28. If reporting transaminitis under “other site,” write in “transaminitis” rather than “liver” when specifying the site. This will prevent queries regarding incorrectly reporting liver GVHD (with bilirubin elevation) under “other site.”
8/12/2021	2450: Post-TED	Modify	The instructions for reporting lower GI stage were updated by adding the Lower GI GVHD and Stool Output Not Documented blue box and removing the following to be consistent with the reporting instructions of the 2100, R7: Lower GI GVHD and Stool Output Not Documented: If diarrhea is attributed to acute GVHD during the reporting period, but the volume of stool output is not documented, leave the lower GI stage data field blank, override the FormsNet3 error as “not documented,” and specify the volume of stool output was not documented. In this case, report Not applicable for the overall grade unless stage 4 acute skin GVHD, stage 4 acute liver GVHD, or an extreme decrease in performance status or stage 2 or 3 acute liver GVHD was also documented at the time point being reported (at diagnosis or maximum grade during the current reporting period) Lower intestinal tract (use mL/day for adult recipients and mL/m2/day for pediatric recipients): Select the stage that reflects the volume of diarrhea attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. Use mL/day for adult recipients and mL/m2/day for pediatric recipients. Input and output records may be useful in determining the volume of diarrhea. Do not report diarrhea ongoing but not attributed to acute GVHD at the time of acute GVHD diagnosis or flare. If diarrhea is attributed to acute GVHD during the reporting period, but the volume of stool output is not documented, report “stage 0” for lower intestinal tract involvement. In this case, report “Not Applicable” for the overall grade unless stage 4 acute skin GVHD, stage 2-4 acute liver GVHD, or an extreme decrease in performance status was also documented at the time point being reported (at diagnosis or maximum grade during the reporting period).Report an overall grade of IV if stage 4 acute skin GVHD, stage 4 acute liver GVHD, or an extreme decrease in performance status is documented at the time point being reported (see GVHD Staging and Grading Table). Report overall grade III if stage 2-3 liver involvement is documented at the time point being reported and there is no evidence of grade IV GVHD.
8/12/2021	2100:Post-Infusion Follow-Up Form	Add	Updated the “Lower GI GVHD and Stool Output Not Documented” blue box with instructions that were missing from the prior 2100: If diarrhea is attributed to acute GVHD during the reporting period, but the volume of stool output is not documented, leave the lower GI stage data field blank, override the FormsNet3 error as “not documented,” and specify the volume of stool output was not documented. In this case, report Not applicable for the overall grade unless stage 4 acute skin GVHD, stage 4 acute liver GVHD, or an extreme decrease in performance status or stage 2 or 3 acute liver GVHD was also documented at the time point being reported (at diagnosis or maximum grade during the current reporting period).
8/6/2021	2450: Post-TED	Remove	Removed the following instructions from the first page of the Post-TED (2450) manual to align with the CPI changes: The Post-TED must be completed at the following time points: 100 days, six months, and annually post-HCT. These forms should be completed as closely to these time points as possible. The structure of the TED Forms is such that each form should fit on a timeline with distinct start and stop dates that do not overlap any other forms, except in the case of a subsequent HCT. The Post-TED is considered past due 120 days after each of these time points.
8/6/2021	2402: Disease Classification	Remove	Removed the following instructions from the first page of the Disease Classification (2402) manual to align with CPI changes: The Disease Classification Form may be submitted to the CIBMTR up to two weeks prior to the start of the recipient’s preparative regimen. The Disease Classification Form is due the day of infusion (day 0), and is past due if not received by that date.
8/6/2021	2400: Pre-TED	Remove	Remove the following sentence from the first page of the instructions for the Pre-TED (2400) manual to align with CPI changes: The Pre-TED may be submitted to the CIBMTR up to two weeks prior to the start of the recipient’s preparative regimen (see Helpful Hint below). The Pre-TED is due the day of the HCT (day 0), and is past due if not received by that date.
8/6/2021	2402: Disease Classification	Add	Clarification added on how to report the the percent of plasma cells when differential is performed but the percent of plasma cells are not listed: Indicate if plasma cells in the peripheral blood by morphologic assessment was “known” or “unknown” at the time of diagnosis. If “known,” report the percentage of plasma cells detected in the blood by morphologic assessment documented on the laboratory report in question 421 and the absolute number documented on the laboratory report in question 422. If a differential was performed and the percentage of plasma cells are not listed, report “known” and specify the plasma cell percentage as “0” in question 422. If only the percentage of plasma cells is available, multiply the percentage of plasma cells by the white blood count (WBC) to determine the absolute number of plasma cells. If “unknown,” continue with question 421.
8/5/2021	Multiple Myeloma Response Criteria	Add	Second bullet point for stringent criteria updated to include BBMT 2017 paper: Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence (confirmation with repeat bone marrow biopsy not needed). (κ/λ ratio ≤ 4:1 or ≥ 1:2 for κ and λ patients, respectively, after counting ≥ 100 plasma cells)
8/5/2021	2402: Disease Classification	Add	Clarification added on how to count the number of lines of therapy when there is prior surgery: A single line of therapy refers to any agents administered during the same time period with the same intent (induction, consolidation, etc.). If a recipient’s disease status changes resulting in a change to treatment, this should be considered a new line of therapy. Additionally, if therapy is changed because a favorable disease response was not achieved, this should be considered a new line of therapy. Do not include surgery when determining the number of lines of therapy.
8/5/2021	Multiple Myeloma Response Criteria	Modify	The third bullet in the “General Reporting Guidelines” was updated: When determining disease status, the difference between free light chain ratios the involved and uninvolved free light chain levels should only be used when both the serum (SPEP) and urine (UPEP) levels are not measurable (Non-Measurable Disease). If either value is measurable (serum M-protein ≥ 1 g/dL or urine ≥ 200 mg/24 hours), then the disease status should be tracked using the measurable M-protein, either the SPEP or the UPEP.

July 2021

7/23/2021	2450: Post-TED	Modify	Reporting instructions on how to report isolated transaminitis for acute GVHD has changed. See red warning box added above question 19: Transaminitis: Previously, if the recipient only had transaminitis related to acute GVHD, this would have been reported as “stage 0” liver GVHD with and overall grade of “not applicable.” However, as of July 2021, isolated transaminitis should not be reported as acute GVHD. In this scenario, report No, acute GVHD did not develop or persist. If the recipient has transaminitis and other organs involved (i.e., skin rash), then report Yes, acute GVHD developed or persisted but do not report there was liver involvement.
7/8/2021	MPN Response Criteria	Modify	Updated the response criteria for Clinical Improvement to be consistent with the IWG criteria: Requires all one of the following maintained for a minimum of 12 weeks. When reporting the date when clinical improvement was achieved, report the first date when the criteria for clinical improvement was met (not the twelve-week date in which clinical improvement was maintained).

June 2021

6/21/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify	The Product Processing as Part of Cryopreservation red box above question 33 was updated: Product Processing as Part of Cryopreservation: Product processing performed as part of the cryopreservation process should not be reported as a separate process. For example, plasma reduction / removal or buffy coat enrichment performed as part of the cryopreservation process should not be reported as product processing.
6/21/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	The blue box above question 58 was added: Viability Testing: When reporting the viability, it is important to consider the sample source used for viability testing. If viability is performed on the entire product, report the viability for the Total Nucleated Cells (TNC) and not the individual cell types (i.e., CD34+, CD3+). However, if viability was performed only on select cell types (i.e., viability was performed on both the CD34+ and CD3+ cells), then report the viability for both CD34+ and CD3+. Similarly, if a product is CD34+ selected and viability is performed on the product post-manipulation, the viability should only be reported for CD34+ cells.
6/21/2021	2450: Post-TED	Modify	The question numbers for “new malignancy” in question 9 were updated with the correct question numbers: New malignancy (including PTLD and EBV lymphoma). Additional stem cells are required because the recipient has developed a new malignancy. This does not include a transformation or progression of the original malignancy for which the recipient was transplanted (refer to question 407 52 for more information). If “new malignancy” is selected, also complete questions 407 – 449 52-59.
6/21/2021	2450: Post-TED	Modify	The instructions for Q1-6 were updated with the following: If the Post-TED Form reports a subsequent infusion (transplant or genetically modified ​cellular therapy), report the date of latest follow-up as the day prior to the start of the preparative regimen / systemic therapy. If no preparative regimen or conditioning / systemic therapy was given, report the day prior to infusion as the date of contact.
6/9/2021	2450: Post-TED	Modify	The “Recurrent Skin Cancers” blue note box in question 52 was updated with the following: For most malignancies, do not report recurrence, progression or transformation of the recipient’s primary disease (disease for which the transplant was performed) or relapse of a prior malignancy in the “New Malignancy” section. For example, a recipient had a basal cell skin cancer diagnosed on the neck four months post-HCT and six months later had another basal cell located on the nose. The lesion on the nose is not considered a metastasis from the neck, but a new discrete lesion. These discrete episodes should be reported as “Basal cell skin malignancy” in the “Other skin malignancy” questions on the Post-TED forms (revision 5, question 52 – 59).

May 2021

5/26/21	Amyloidosis Response Criteria	Modify	The Partial Response criteria for Hematologic Response was updated to be consistent with the amyloid response criteria: * ≥ 50% reduction in current serum monoclonal protein levels (if > 0.5 g / dL or > 5 g / L at baseline) > 0.5 g/dL * ≥ 50 reduction in urine light chains (if >100 mg / day at baseline) ≥ 50% reduction in current urine m-protein levels > 100 mg/day with a visible peak * ≥ 50 decrease in clonal serum free light chain levels (if >10 mg / dL or >100 mg / L at baseline) ≥ 50% reduction in current free light chain levels > 10mg/dL
5/26/2021	2450: Post-TED	Modify	Example B for the One Year Post-TED Form in the Intervention Reporting Scenarios under Q114 was updated: Q111 – 118: Report “Yes” to indicate therapy was given for relapsed disease during this reporting period. Q112: Report “Relapsed / progressive disease.” Q113: Check the clinical/hematologic disease assessment box. Centers are instructed to check the boxes for all methods of assessment performed prior to the start of treatment which confirmed the reason therapy was given (question 112). This includes assessments which may have been performed during a prior reporting period. Q114: Report “9/20/2014” to reflect the date of the first treatment given for progressive disease. Reporting a date outside the current reporting period will cause a FormsNet3SM error. Centers are instructed to override this error using the code “Verified Correct.” Q115-118: Report both bortezomib as treatment for progressive disease given during the reporting period. These questions will be disabled in the FormsNet3SM system. Starting with Revision 5 of the Post-TED 2450, therapy given for relapsed or progressive disease will only be captured in the reporting period in which treatment first started.
5/21/2021	4100: Cellular Therapy Essential Data Follow-Up	Modify	The blue box above questions 21-22 was updated: This section is applicable to malignant diseases only and does not only applies to Letetresgene autoleucel, other products, or cellular therapies with no product name commercially available products.
5/21/2021	2400: Pre-TED	Modify	Question 60 was updated with the following changes: If the donor is a NMDP unrelated cord blood unit or a product is NMDP facilitated (PBSC or marrow product), as noted in question 55, indicate the GRID number and continue with question 72. If the donor is a non product is not NMDP facilitated unrelated donor (PBSC or marrow product), as noted in question 55, indicate the GRID number and continue with question 63. If the donor is a non NMDP unrelated cord blood unit, indicate the GRID number and continue with question 61.
5/12/2021	4100: Cellular Therapy Essential Data Follow-Up	Add	Added new example 4 for hypogammaglobulinemia resolution date when testing is not exactly at 3 months.
5/7/2021	4000: Cellular Therapy Essential Data Pre-Infusion	Add	Instructions added to question 108 on how to report psychiatric comorbidity: The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks. Do not report a psychiatric comorbidity if therapy was given “as needed” for any mood, anxiety, or other psychiatric disorder
5/6/2021	2000: Recipient Baseline	Add	Question 2 updated with instructions on how to report use of naswar or paan: Indicate the recipient’s smoking and / or chewing tobacco use from the options listed. Select “chewing tobacco” if the recipient has a history using naswar and / or paan. If “cigarettes” is selected, continue with question 3.
5/6/2021	2100: Post-HCT Follow-Up	Modify	The following instructions were updated for question 661 were updated: Select the category that best describes the recipient’s current occupation. If the recipient is a student, check “student.” If the recipient is younger than school-aged, check “under school age” and continue with question 665. If “other” is selected, report the recipient’s occupation in question 662. Only one work status may be reported. If a recipient has multiple possible occupations during the current reporting period, report the highest level of work being performed. For example, full time work would be reported over part time work and part time work would be reported over being a student. If the recipient is not currently employed on the date of contact or not employed at any time during the current reporting period, check the box that best describes his / her last job in the current reporting period. If the recipient was not employed at any time during the current reporting period, select “Not employed during this reporting period” and continue with question 665.
5/6/2021	2450: Post-TED	Add	The following instructions were added to question 1 for date of contact and subsequent infusion: Date of Contact & Subsequent Infusion If the recipient has a subsequent infusion (HCT or cellular therapy), the date of contact will depend on the type of subsequent infusion. If the subsequent infusion is an HCT or genetically modified cellular therapy (e.g. CAR-T), report the date of contact as the day before the preparative regimen / systemic therapy begins for the subsequent infusion. If no preparative regimen / systemic therapy is given, report the date of contact as the day before the subsequent infusion. In these cases, actual contact on that day is not required, and the day prior to the initiation of the preparative regimen (or infusion, if no preparative regimen / systemic therapy) should be reported. This allows every day to be covered by a reporting period but prevents overlap between infusion events. If the subsequent infusion is a non-genetically modified (e.g. DLI) cellular therapy infusion, report the date of contact as appropriate to the reporting period.
5/6/2021	2400: Pre-TED	Add	Clarification added to question 55 that a 2004 and 2005 form will not come due when the product is facilitated by NMDP
5/6/2021	2450: Post-TED	Modify	Updated the question numbers in the red warning box above question 108
5/5/2021	2100: Post-HCT Follow-Up	Modify	The following instructions were updated for questions 486 – 487: Indicate whether the recipient received endotracheal intubation or mechanical ventilation (invasive positive pressure ventilation) post-HCT since the date of last report. If “yes,” report the date when endotracheal intubation or mechanical ventilation was started in question 487. If the recipient was intubated multiple times within the reporting period, please report the first date of intubation. If “no,” continue with question 490. Please report “no” if the patient received endotracheal intubation or mechanical ventilation during surgery.
5/5/2021	2130: SCD Post-Infusion	Add	The Bedside Schwartz equation was added to questions 36 -37 to calculate the GFR for pediatric recipients.
5/5/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	The following instructions were added for buffy coat enriched for question question 33: Buffy coat enriched: Buffy coat enrichment is performed to reduce/remove mature erythrocytes and plasma. Buffy coat enrichment performed as part of the cryopreservation process should not be reported as product processing.
5/5/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Red warning box added above quetion 33: Product Processing as Part of Cryopreservation: Product processing performed as part of the cryopreservation process should not be reported as a separate process. For example, plasma reduction / removal performed as part of the cryopreservation process should not be reported as product processing.
5/5/2021	Plasma Cell Leukemia Response Criteria	Add	The following criteria was added for relapse: Appearance of any other sign of progression such as: Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression), Hypercalcemia (> 11mg/dL), Decrease in hemoglobin of ≥ 2 g/dL not related to therapy or other non-myeloma-related conditions, Rise in serum creatinine by 2 mg/dL or more from the start of therapy and attributable to myeloma, Hyperviscosity related to serum paraprotein
5/5/2021	Plasma Cell Leukemia Response Criteria	Modify	The response criteria for CR, VGPR, and PR were re-formatted and split between measurable and non-measurable disease.
5/5/2021	Plasma Cell Leukemia Response Criteria	Add	Confirmatory Assessments for PCL red warning box added: 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. Review the examples below for further clarification.
5/5/2021	Plasma Cell Leukemia Response Criteria	Add	Urine Studies blue note box added: In order to report a Stringent Complete Response (sCR) or Complete Response (CR), urine studies MUST be performed and agree with the international myeloma working group (IMWG) criteria provided above. 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 sCR or CR.

April 2021

4/28/2021	Appendix J: Reporting Comorbidities	Add	Updated the table “What not to report” for psychiatric comorbidity when treatment is given “as needed.”
4/28/2021	2400: Pre-TED	Add	Clarification added on how to report a psychiatric comorbidity when treatment is given “as needed”: The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks. Do not report a psychiatric comorbidity if therapy was given “as needed” for any mood, anxiety, or other psychiatric disorder.
4/28/2021	2450: Post-TED	Remove	The instructions for questions 116 – 117 were updated by removing the following: Form options are arranged alphabetically. Indicate which systemic therapy agents were administered during the current reporting period for reasons other than relapse, persistent, or progressive disease. If the recipient received a chemotherapy agent that is not listed (e.g. cyclophosphamide), “chemotherapy” should be selected. If the recipient received a therapeutic agent, other than chemotherapy, that is not listed, select “other systemic therapy” and specify the systemic therapy in question 117.
4/28/2021	MPN Response Criteria	Add	For CR, Myelofibrosis CR, and PR, neutrophilic precursors clarification added: Neutrophilic precursors* reduced to ≤ 2% (*neutrophilic precursors include myeloblasts, promyelocytes, myelocytes, & metamyelocytes)
4/28/2021	2130: SCD Post-Infusion	Modify	Instructions on when to report not applicable for questions 74 – 75 were updated: If RBC transfusion(s) were given within four weeks prior of the hemoglobin electrophoresis, report Not applicable and go to question 89.
4/14/2021	AML Response Criteria	Add	Transfusion independent clarification added for CR and CRi: Transfusion independent (a minimum of eight weeks without platelet or red blood cell transfusion)

March 2021

3/25/2021	2100: Post-HCT Follow-Up	Add	Clarification added on when to use the “previously reported” option for platelet recovery (questions 13 and 16).
3/22/2021	2402: Disease Classification	Add	Added the following instruction for question 405: The Durie-Salmon stage is only required if the recipient’s I.S.S. stage at diagnosis cannot be determined and is not reported in questions 415-416.
3/17/2021	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Clarification added to the blue note box about reporting co-morbidities within 6 months of the cellular therapy: Please report co-morbidities that occurred were detected within six months of the cellular therapy, which is different than HCT reporting. The 6 month rule applies to assessments that need to be performed in order to determine if a comorbidity is present (i.e., PFT for pulmonary, liver values for hepatic, creatinine for renal, BMI for obesity, etc.). If the co-morbidity is denoted as “ANY history”, the 6 month rule does not apply.
3/9/2021	2900: Recipient Death	Add	Primary Cause of Death blue note box added above question 4: Primary Cause of Death: Report the primary cause of death based on the physician’s determination. If the cause of death is unclear, seek physician clarification to determine the appropriate cause of death/
3/9/2021	2804: CIBMTR Research ID Assignment Form	Add	Added the following instructions to question 10: Indicate the detailed race of the recipient. If this recipient has reported that they are more than one detailed race, check each detailed race indicated in the list below that applies. If the race detail is not documented or is not known, select “unknown.”
3/9/2021	2804: CIBMTR Research ID Assignment Form	Remove	Removed the following instructions from question 9: Indicate the recipient’s race. If this recipient has reported that they are more than one race, check each race indicated in the list below that applies. The race groups provided are specific to the United States. If the recipient is White, Southeast Asian, or Pacific Islander, but a more specific Race Detail is not available, report the patient is “Other [White, Southeast Asian, or Pacific Islander respectively].
3/9/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Product Processing blue note box added above question 33: Product Processing: Wash and dilution, both which generally apply to cord blood units, are now included as processing options, though they may not be classified as such by laboratories. If dilution is performed as part of washing, dilution should not need be reported. Only report the primary procedure. See the Steps in Manipulation note box below.
3/8/2021	2400: Pre-TED	Modify	Blue note box above questions 102-111 updated: Complete questions 102 – 111 using the results measured within four weeks prior to the closest to the start of the preparative regimen. If the assessment was performed multiple times, report the closest value to the start of the preparative regimen. The following are considered biomarkers according to the augmented HCT comorbidity index.
3/8/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	The following information was added to question 153: It should be noted for cord blood unit transplants that almost all units are screened, or the infant is screened, for potentially transplantable genetic diseases. This may be documented as a ‘hemoglobin screen,’ which evaluates for sickle cell and/or thalassemia, both of which are hemoglobinopathies.
3/8/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Instructions on how to report the date of product analysis, depending on if the the product was analyzed multiple times and examples 1 – 3 were added to question 42.
3/8/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Added the following statement to question 41: The At Infusion timepoint should include values reflective of the product infused regardless of when the analysis occurred. Since all products are analyzed prior to cryopreservation, the At Infusion timepoint would be applicable for these cell counts. Depending on the product type and your center’s practice, viability may be assessed closer to the time of infusion.
3/8/2021	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Example 1 added to questions 2-3: Example 1: The donor was mobilized with Granix (tbo-Filgrastim) prior to the start of collection. Since this is a biologic medical product that is highly similar to Neupogen, this would be captured under G-CSF.
3/8/21	Appendix E: Definition of a Product	Modify	Graphic below the “Single Product vs Multiple Products” was added and examples 1 – 5 were update.
3/3/2021	2047/2147: Hepatitis Serology	Removed	Removed the following instructions as they are inaccurate: This form will also come due if a recipient received cells from a donor who was reported as “reactive” on the Form 2004, Infectious Disease Markers: Hepatitis B surface Antigen Hepatitis B core Antibody Hepatitis C Antibody
3/3/2021	2047/2147: Hepatitis Serology	Removed	Removed the following instructions as they are inaccurate: Because viral hepatitis can be transmitted from the donor to the recipient via hematopoietic stem cell transplantation, this form will also be triggered when any of the following IDMs are reported as “reactive” on the Form 2004, Infectious Disease Markers: Hepatitis B surface Antigen Hepatitis B core Antibody Hepatitis C Antibody
3/3/2021	2450: Post-TED	Add	Example F added above question 84, under the header “Disease Assessments at the Time of Best Response:” A recipient receives a transplant on 1/1/2020 for IgA Kappa Multiple Myeloma in stable disease. During the 100 Day reporting period, the first set of myeloma labs on Day 29, 1/30/2020, show progressive disease. Myeloma labs repeated on Day 60 and Day 100 also showed disease progression. As a result, therapy is planned to be given, starting in the 6-month reporting period, on Day 110. The best response to HCT for the Day 100 reporting period would be reported as “Not in complete remission – disease detected” and report “Yes,” clinical / hematologic assessments were performed with the Day 100 myeloma labs, as this is the most recent testing in the reporting period. In cases where the first assessment post-HCT shows progression, report the last assessment prior to the start of treatment. If treatment doesn’t start until the next reporting period, report the last assessment in the current reporting period.

January 2021

1/25/2021	2400: Pre-TED	Modify	Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.
1/25/2021	2402: Disease Classification	Modify	Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.
1/25/2021	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.
1/22/2021	3501: Pregnancy Form	Add	Version 1 of the 3501 Pregnancy Form section of the Forms Instructions Manual released. Version 1 corresponds to revision 2 of the Form 3501.
1/22/2021	4100: Cellular Therapy Essential Data Follow-Up	Modify	Version 6 section of the Forms Instruction Manual released. Version 6 corresponds to revision 6 of the Form 4100.
1/22/2021	4006: Cellular Therapy Infusion	Modify	Version 5 of the 4006: Cellular Therapy Infusion section of the Forms Instruction Manual released. Version 5 corresponds to revision 5 of the Form 4006.
1/22/2021	4003: Cellular Therapy Product	Modify	Version 4 of the 4003: Cellular Therapy Product section of the Forms Instruction Manual released. Version 4 corresponds to revision 4 of the Form 4003.
1/22/2021	4000:Cellular Therapy Essential Data Pre-Infusion	Modify	Version 5 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 5 corresponds to revision 7 of the form 4000.
1/22/2021	2400: Pre-TED	Modify	Version 7 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 7 corresponds to revision 8 of the Form 2400.
1/21/2021	2820: Recipient Contact Information	Modify	Instruction text updated: This question should be answered ‘yes’ if the recipient has given permission to be directly contacted by CIBMTR for research as indicated on the Pre-TED F2400 consent tool. This will allow CIBMTR to contact the patient and invite them to participate in PRO data collection or other research studies.
1/11/2021	2402: Disease Classification	Add	Clarification added on how to report the number of lines of therapy prior to infusion when there is a prior infusion and / or transformation along with examples 1 and 2: A single line of therapy refers to any agents administered during the same time period with the same intent (induction, consolidation, etc.). If a recipient’s disease status changes resulting in a change to treatment, this should be considered a new line of therapy. Additionally, if therapy is changed because a favorable disease response was not achieved, this should be considered a new line of therapy. Report the total number of lines of therapy received since the original lymphoma diagnosis up until the start of the preparative regimen / infusion, regardless of if the recipient has received a prior infusion. Indicate how many lines of therapy the recipient received prior to the start of the preparative regimen / infusion. Example A: A recipient received a line of induction and achieved CR. However, following induction, the recipient relapsed and received a line of re-induction with no response. After re-induction, the recipient transformed, received a different line of re-induction followed by consolidation and achieved CR2 prior to HCT. This would be considered as four separate lines of therapy and the total number of lines of therapy reported in this example would be “3+ lines.” Example B: A recipient received a line of induction, achieved CR, and then went to HCT. Post-transplant, the recipient transformed, received a line of re-induction followed by a line of consolidation and achieved CR2 prior to the second HCT. In this scenario, the recipient received three lines of therapy and “3+ lines” would be reported.
1/7/2021	4100: Cellular Therapy Essential Data Follow-Up	Add	Clarified when to report hypogammaglobulinemia, how to report date of onset and date of resolution. Several examples have been added.

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