2019 Manual Updates

January 2019
February 2019
March 2019
April 2019
May 2019
June 2019
July 2019
August 2019
October 2019
December 2019

Updates made during the current calendar year are included below. For updates prior to 2019, 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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December 2019

Date	Manual Section	Add/Remove/Modify	Description
12/16/2019	F4100 Cellular Therapy Essential Data Follow-up”	Modify	Added the following note about DCI/DLI infusions in questions 14 and 16. Check “not applicable” for DCI/DLI infusions where a preparative regimen was not given

October 2019

Date	Manual Section	Add/Remove/Modify	Description
10/31/2019	F4100 Cellular Therapy Essential Data Follow-up”	Modify	Depressed level of consciousness: A disruption in how the brain works that causes a change in behavior. This change can happen suddenly or over days and ranges from slight confusion to total disorientation and increased sleepiness to coma.
10/25/19	2804: CIBMTR Research ID Assignment Form	Modify	Version 5 of the 2804: CIBMTR Research ID Assignment section of the Forms Instructions Manual released. Version 5 corresponds to revision 6 of the Form 2804.
10/25/19	Multiple Myeloma Response Criteria	Modify	Removed the previously modified (struck out text has been deleted and red text has been added) response criteria for Relapse from CR: Relapse from CR Requires one or more of the following: Reappearance of serum or urine M-protein by immunofixation or electrophoresis; and/or Development of ≥ 5% plasma cells in the bone marrow; and/or Appearance of any other sign of progression (e.g., new plasmacytoma, lytic bone lesion, hypercalcemia). Positive immunofixation alone in a patient previously classified as achieving a complete response should not be considered a relapse.

August 2019

Date	Manual Section	Add/Remove/Modify	Description
8/29/2019	“4006: Product Identification”	Modify	Updated instruction in pink warning box above question 17: Question 17-45: Reporting total number of cells Report the total number of cells (not cells per kilogram) contained in the product administered not corrected for viability.
8/14/2019	4000: Cellular Therapy and HCT History	Modify	Updated instruction for question 24: If “yes”, continue to question 29. If “no”, continue with question 25. If “unknown”, questions 25, 26, and 28 are optional and you can continue to question 23.
8/14/2019	4000: Cellular Therapy and HCT History	Modify	Updated instruction for question 15: If “yes”, continue to question 23. If “no”, continue with question 16. If “unknown”, questions 16, 17, 18, and 22 are optional and you can continue to question 23.
8/2/19	2820: Recipient Contact Information	Modify	Version 2 of the 2820: Recipient Contact Information section of the Forms Instructions Manual released. Version 2 corresponds to revision 2 of the Form 2820.

July 2019

Date	Manual Section	Add/Remove/Modify	Description
7/3/19	2400: Pre-TED	Modify	Updated (new text in red and removed text struck out below) the blue note box under question 40 regarding Haploidentical donors: Haploidentical Donors A HLA-haploidentical donor is one who shares, by common inheritance, exactly one HLA haplotype with the recipient and is mismatched for a variable number of HLA genes, ranging from zero one to five, on the unshared haplotype. Potential HLA-haploidentical donors include biological parents; biological children; full or half siblings; and even extended family donors such as aunts, uncles, nieces, nephews, cousins, or grandchildren. Indicate “HLA-mismatched relative” for question 40 if a haploidentical donor was used for the HCT.

June 2019

Date	Manual Section	Add/Remove/Modify	Description
6/27/19	4006: Cellular Therapy Infusion	Modify	Added additional information to the manual providing specific reporting instructions for commercially available products.
6/27/19	4003: Cellular Therapy Product	Modify	Added additional information to the manual providing specific reporting instructions for commercially available products.
6/27/19	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Added additional information to the manual providing specific reporting instructions for commercially available products.
6/17/19	2400: Pre-TED	Modify	Added additional information (in red below) to the instructional text for question 40 to better define the related donor types listed on the form: Indicate the relationship and match between the recipient and the donor. Only consider HLA-A, B, C, and DRB1 when determining the donor’s match / mismatched relationship to the recipient. Syngeneic: Includes: Monozygotic (identical) twins. Occurs when a single egg is fertilized to form one zygote, which then divides into two separate embryos. Does not include: Other types of twins or HLA-identical siblings (see below). HLA-identical sibling: Includes: Non-monozygotic (dizygotic, fraternal, non-identical) twins. Occurs when two eggs are fertilized by two different sperm cells at the same time. This category also includes siblings who aren’t twins, but have identical HLA types. The patient and donor will be allele-level matched at HLA-A, B, C, and DRB-1. Does not include: Half-siblings (report as “HLA matched other relatives” if their HLA is a match, or “mismatched relative” if it does not match). HLA-matched other relative: Includes: All blood-related relatives, other than siblings, who are HLA matched (e.g., parents, aunts, uncles, children, cousins, half-siblings). The patient and donor will be allele-level matched at HLA-A, B, C, and DRB1. Does not include: Adoptive parents/children or stepparents/children who are HLA matched. HLA-mismatched relative: Includes: Siblings who are not HLA-identical and all other blood-related relatives who have at least one HLA mismatch (e.g., parents, aunts, uncles, children, cousins, half-siblings). This includes haploidentical donors. The patient and donor will be allele-level mismatched at one or more loci (HLA-A, B, C, or DRB1). Does not include: Adoptive parents/children or stepparents/children.

May 2019

Date	Manual Section	Add/Remove/Modify	Description
5/14/2019	F4100 Cellular Therapy Essential Data Follow-up	Remove	Removed note box Survival status For scenarios where both HCT and CT forms will be submitted at the same time, there are duplicate questions across the F2100 and F4100. To reduce the reporting burden, duplicated questions on the Cellular Therapy forms are disabled. This includes Survival Status reported on F4100.

April 2019

Date	Manual Section	Add/Remove/Modify	Description
4/26/19	2540: Tepadina Supplemental Data Collection	Modify	Version 2 of the 2540: Tepadina Supplemental Data Collection section of the Forms Instruction Manual released. Version 2 corresponds to revision 2 of the Form 2540.
4/26/19	2814: Indication for CRID Assignment	Modify	Version 3 of the 2814: Indication for CRID Assignment section of the Forms Instructions Manual released. Version 3 corresponds to revision 3 of the Form 2814.
4/19/19	Multiple Myeloma Response Criteria	Modify	Modified (struck out text has been deleted and red text has been added) the response criteria for Relapse from CR: Relapse from CR Requires one or more of the following: Reappearance of serum or urine M-protein by immunofixation or electrophoresis; and/or Development of ≥ 5% plasma cells in the bone marrow; and/or Appearance of any other sign of progression (e.g., new plasmacytoma, lytic bone lesion, hypercalcemia). Positive immunofixation alone in a patient previously classified as achieving a complete response should not be considered a relapse.
4/19/19	Waldenstrom’s Macroglobulinemia Response Criteria	Add	Added (in red below) the following text for the Progressive Disease response criteria: Progressive disease (PD) ≥ 25% increase in serum monoclonal IgM spike from lowest nadir on serum electrophoresis and/or Progression of clinically significant findings or symptoms (for example, anemia, adenopathy, constitutional symptoms, amyloidosis, etc.) attributed to WM/LPL
4/19/19	2131: ID Post-HCT	Modify	Updated the engraftment statuses for questions 167 – 172. The engraftment status have been updated (struck out text has been deleted and red text has been added) as follows: Predominantly or completely donor (≥80% donor chimerism) Mixed chimerism (5 – 79 80% donor) Only host cells detected (<5% donor)
4/19/19	Appendix J: Reporting Comorbidities	Add	Added (in red below) instruction for reporting a cardiac comorbidity: The presence of one or more of the following: Any history of coronary artery disease (one or more vessels requiring medical treatment, stent, or bypass), Any history of myocardial infarction, or Any history of congestive heart failure , or LVEF ≤ 50% (or a shortening fraction (SF) of < 26% for pediatric cases) on most recent evaluation prior to the start of the preparative regimen Also added instruction to the blue not box describing Hepatic and Renal comorbidities to clarify what to report based on laboratory values closest to the start of the preparative regimen.
4/19/19	Appendix D: How to Distinguish Infusion Types	Modify	Updated the Co-infusion (with HCT) section to reflect updated cellular therapy forms (added text in red below) When reporting co-infusions, the Cellular Therapy Product form (4003) and Cellular Therapy Infusion form (4006) is are required for all recipients. The HCT Infusion form (2006) will capture information regarding the product intended for engraftment.
4/19/19	Amyloidosis Response Criteria	Modify	Modified the following sections (removed text is struck out below, added text is in red) of the Amyloidosis Response Criteria: Partial Response: ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL ≥ 50% reduction in current urine light chain urine m-protein levels > 100 mg/day with a visible peak ≥ 50% reduction in current free light chain levels > 10mg/dL Renal Response: ≥ 50% decrease of at least 0.5 g/day (500mg/24hr) in 24-hour urine protein of > 0.5 g/day (500mg/24hr) pre-treatment and Creatinine clearance or serum creatinine must not have worsened by ≥ 25% over baseline If only serum creatinine is obtained, an estimated creatinine clearance can be calculated using the following formula: Estimated Creatinine Clearance = [(140 – Age (years)) * Weight (kg)] / [72 * Serum Creatinine (mg/dL)] The calculation should be multiplied by 0.85 for women.
4/19/19	2450: Post-TED	Modify	Provided additional instruction and examples for reporting the current disease status in Questions 237-238.
4/11/19	2450: Post-TED	Modify	Updated the instruction on how to report Dexamethasone if given for disease relapse or progression post-HCT. Dexamethasone should be reported as “Other Systemic Therapy,” not “Other Therapy.”

March 2019

Date	Manual Section	Add/Remove/Modify	Description
3/19/19	2450: Post-TED	Add	Added the following red warning box instruction (in red below) below question 75 to clarify when to use the CCR option in the Disease Assessment at the Time of Best Response to HCT section of the Post-TED (2450) form: Continued Complete Remission (CCR) should be reported for all patients who were already in CR at the start of the preparative regimen.

February 2019

Date	Manual Section	Add/Remove/Modify	Description
2/27/19	2116: PCD Post-HCT	Add	Added (in red below) additional instruction for question 61: However, bisphosphonate therapy (e.g., Zometa) should not be reported as planned therapy since it is universally administered to myeloma patients. Additionally, supportive care such as Denosumab (e.g., Prolia) should not be reported as planned therapy.
2/27/19	2402: Disease Classification	Add	Added (in red below) additional instruction for question 277: Question 277: Was a PET (or combination PET / CT) scan performed? (at last evaluation prior to the start of the preparative regimen / infusion) Report “Yes” and go to question 278 if a PET scan was performed within three months prior to the start of the preparative regimen / infusion. Combination PET / CT may also be reported, but a CT scan alone should not be captured here. Centers may report a PET scan performed during the most recent line of therapy so long as it is the most recent scan and was done within noted period. Report “No” and go to question 283 if a PET scan was not performed within this period.
2/27/19	Appendix J: Reporting Comorbidities	Remove	Removed (struck out below) incorrect instruction for reporting Cerebrovascular disease comorbidities: Any history of: Trasient ischemic attack Cerebrovascular accident / stroke Subarachnoid, hemoorhage: do not include subdural, epidural, or intraparenchymal hemorrhage
2/27/19	2402: Disease Classification	Add	Added (in red below) additional instruction for question 165: Indicate the number of times the recipient has been in the disease phase reported in question 163.
2/27/19	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Added additional instruction (in red below) regarding T-Cell depletion under questions 73-95: T-Cell depletion: T-cell depletion removes some or all of the T cells in an effort to minimize GVHD. Methods of T-cell depletion include antibody affinity column, antibody-coated plates, antibody-coated plates and soybean lectin, antibody + toxin, immunomagnetic beads, CD34 affinity column plus sheep red blood cell resetting, and T-cell receptor alpha / beta depletion.
2/27/19	2400: Pre-TED	Modify	Modified (removed text is struck out below, updated text is in red) the instructions for question 52 on where to report cellular therapy product data for products that are not intended to achieve hematopoietic engraftment. If infusions of additional cells (not intended to produce engraftment) were given prior to the HCT being reported (i.e., prior to clinical day 0), the cells must be reported as a product on the Pre-TED Form (Form 2400, question 51) and on a separate Cellular Therapy Infusion Product Form (Form 4006 4003). If the additional cells were infused post-HCT, for any reason other than a subsequent HCT, they should be reported as a DCI on the appropriate follow-up form. Reporting the additional cells (given pre-HCT and not intended to produce engraftment) on the Form 4006 4003 is the only mechanism the CIBMTR has in place to collect this data and ensure that the quality assurance data is reported to cord blood banks, if applicable.
2/27/19	2556: Myelofibrosis Pre-HCT Data and 2557: Myelofibrosis Post-HCT Data	Remove	Removed text referencing the CMS study for Myelofibrosis. The 2556 and 2557 are required for all patients with Myelofibrosis, not just patients enrolled in the CMS study. The titles of the forms have already been changed to remove CMS study from the title.
2/1/2019	Cellular Therapy Manuals	Modify	Added clarification (in red below): What cellular therapies to report and when: Cellular therapy given in context of HCT (e.g. co-infusion, DLI/DCI): When a cellular therapy is given in context of a transplant, such as a co-infusion with an HCT or a DLI/DCI post-HCT, these infusions need to be reported to the CIBMTR. This includes both autologous and allogeneic products, such as cell stored prior to an allogeneic HCT used for treatment of graft failure. Cellular therapy given with a prior HCT (e.g. CAR T-cell therapy for treatment of relapse): When a cellular therapy (e.g. CAR T-cell therapy) is given and there is a prior HCT, reporting these infusions are voluntary at this time. Stand-alone cellular therapy (no prior HCT) (e.g. CAR T-cells): reporting these infusions are voluntary at this time*. *Reporting of commercial products infusions (i.e. Kymriah, Yescarta) is strongly encouraged.

January 2019

Date	Manual Section	Add/Remove/Modify	Description
1/25/2019	4003: Cellular Therapy Product	Modify	Version 2 of the 4003: Cellular Therapy Product section of the Forms Instruction Manual released. Version 2 corresponds to revision 2 of the Form 4003.
1/25/2019	2900: Recipient Death	Modify	Version 3 of the 2900: Recipient Death section of the Forms Instructions Manual released. Version 3 corresponds to revision 4 of the Form 2900.
1/25/2019	2018: LYM Pre-Infusion	Modify	Version 4 of the 2018: Lymphoma Pre-Infusion Data section of the Forms Instruction Manual released. Version 4 corresponds to revision 5 of the Form 2018.
1/24/2019	4100: Cellular Therapy Essential Data Follow-up	Modify	Added examples (in red below) in question 33 on when to use “previously reported” option: If a new malignancy is reported, please complete the Subsequent Neoplasms Form 3500 to answer questions specific to the new malignancy. The option of ‘Previously reported’ should only be used if the same new malignancy instance has already been reported on a F3500. See examples below. If there is a question regarding use of this option, please contact your CIBMTR CRC. Example 1. Recipient develops a new malignancy at day +68. It is reported at the time the 100-day form 4100 is completed. Question 33 should be answered as ‘yes’ and the form 3500 should be completed to report all new malignancy information. Example 2. Recipient develops a new malignancy at day +68 and had received a commercial CAR-T product. Per protocol, the new malignancy should be reported at the time of knowledge of the new malignancy. The form 3500 should be created as an unscheduled form in FormsNet3 and completed in a timely manner. No other new malignancy develops during the 100-day reporting period. When the 100-day form 4100 is completed, question 33 should be answered as ‘previously reported’. Example 3. Recipient develops a new malignancy at day +68 and had received a commercial CAR-T product. Per protocol, the new malignancy should be reported at the time of knowledge of the new malignancy. The form 3500 should be created as an unscheduled form in FormsNet3 and completed in a timely manner. Another new malignancy develops at day +100. It is decided to report the 2nd new malignancy on the 100-day form 4100 since it is due. Question 33 should be answered as ‘yes’ to create another form 3500.
1/17/2019	4100: Cellular Therapy Essential Data Follow-Up	Modify	Added (in red below) clarification on how hypogammaglobulinemia is documented: Report the date (YYYY-MM-DD) in question 126 when the hypogammaglobulinemia was documented by either a physician/health care provider or determined by lab results. If the hypogammaglobulinemia continues from a prior reporting period, report the original diagnosis date as the onset date and override the error. Example 1. The recipient developed hypogammaglobulinemia at day +22 which was reported on the 4100 day 100 form. The lab results continue to show IgG levels < 600 mg/dl during the 6 month reporting period. Report the original diagnosis date on the 4100 6 month form and override the error.
1/17/2019	4000: Cellular Therapy Essential Data Pre-Infusion	Remove	Removed the following blue note box instruction (struck out below) for questions 250 to 252 functional status. Functional status should be reported for every indication. These questions are for malignant disease indications or relapsed, persistent, or progressive disease only.

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