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.
|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|
|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
|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:
|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
|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.|
|7/3/19||2400: Pre-TED||Modify|| Updated (new text in red and removed text
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
|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.
|5/14/2019||F4100 Cellular Therapy Essential Data Follow-up||Remove|| Removed note box
|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:
|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)
|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:
|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:
|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)
|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:
|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.”|
|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.
|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:
|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
|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:
|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.
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