2016 Manual Updates

December 2016
August 2016
July 2016
June 2016
April 2016
March 2016
February 2016
January 2016

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December 2016

Date	Manual Section	Add/Remove/Modify	Description
12/12/2016	2013: CLL Pre-Infusion	Modify	Instructions for Revision 2 of the CLL Pre- and Post-HCT Forms were retired and instructions for Revision 3 of the CLL Pre- and Post-Infusion Forms were released.
12/12/2016	2113: CLL Post-Infusion	Modify	Instructions for Revision 2 of the CLL Pre- and Post-HCT Forms were retired and instructions for Revision 3 of the CLL Pre- and Post-Infusion Forms were released.

August 2016

Date	Manual Section	Add/Remove/Modify	Description
8/29/16	2804: CIBMTR Research ID Assignment form	Add	Added information banner to 2804 introduction page: Reporting of all HCTs is important to ensure the continued epidemiological integrity of the CIBMTR outcomes registry. The exception to this is if your center performs but does not report autologous HCTs.
8/29/16	2131: ID Post-HCT	Add	Added information box under question 25: If CD56+ cells were not tested, centers may report CD16+ results in these data fields.
8/29/16	2031: ID Pre-HCT	Add	Added information box under question 33: If CD56+ cells were not tested, centers may report CD16+ results in these data fields.
8/29/16	2200: Six Months to Two Years Post-HCT	Add	Added text to information banner beneath question 43: The CD20+ data field can capture CD19+ or CD20+ cells. The CD56+ data field can capture CD56+ or CD16+ cells.
8/29/16	2100: 100 Days Post-HCT	Add	Added text to the information banner beneath question 72: The CD20+ data field can capture CD19+ or CD20+ cells. The CD56+ data field can capture CD56+ or CD16+ cells.
8/26/16	2131: ID Post-HCT	Add	Added information box under question 24: If CD20+ cells were not tested, centers may report CD19+ results in these data fields.
8/26/16	2031/2131: Immune Deficiencies	Add	Added information box under question 32: If CD20+ cells were not tested, centers may report CD19+ results in these data fields.
8/26/16	2200: Six Months to Two Years Post-HCT	Add	Added text to Table 3 to clarify how centers should report chimerism testing performed on sorted marrow samples.
8/26/16	2100: 100 Days Post-HCT	Add	Added text to Table 3 to clarify how centers should report chimerism testing performed on sorted marrow samples.
8/26/16	ALL Response Criteria	Add	Added alternative post-HCT CR criteria for pediatric recipients.
8/26/16	ALL Response Criteria	Modify	Updated relapse criteria: Relapse is defined as the recurrence of disease after CR, meeting at least one of the following criteria
8/26/16	Multiple Myeloma Response Criteria	Modify	Updated PR criteria: If the serum and urine M-protein are not measurable (i.e., do not meet the following criteria at time of diagnosis):
8/26/16	2100: 100 Days Post-HCT	Add	Added the following information text to question 452: If the recipient receives a subsequent HCT prior to day 100, do not include the start date of the preparative regimen for the subsequent HCT (or the date of the subsequent infusion if no preparative regimen was given).

July 2016

Date	Manual Section	Add/Remove/Modify	Description
7/29/16	4000: Cellular Therapy Essential Data Pre-Infusion	Add	Version 1 Released
7/29/16	4006: Cellular Therapy Infusion	Add	Version 1 Released
7/29/16	4100: Cellular Therapy Essential Data Follow-Up	Add	Version 1 Released
7/26/16	2553: VOD/SOS	Add	Version 1 Released
7/26/16	2814: Indication for CRID Assignment	Modify	Version 2 Released
7/18/16	2013: CLL Pre-HCT	Modify	Updated all question numbers to match the current version of the CLL Pre-HCT Disease Insert

June 2016

Date	Manual Section	Add/Remove/Modify	Description
6/27/16	Multiple Myeloma Response Criteria	Modify	Changed text in information box regarding Urine Studies: In order to report a Stringent Complete Remission (sCR) or Complete Remission (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. Urine electrophoresis and immunofixation studies may not be performed in all cases. The disease response options below (Near Complete Remission, Very Good Partial Response, and Partial Response) may still be reported even if urine studies were never obtained or were only obtained at diagnosis. If urine studies were performed following the most recent line of therapy, the results must agree with the international working group IMWG criteria for the disease status being reported. In any case, serum studies MUST be performed and agree with the international working group criteria for the disease status being reported (excluding non-secretory myeloma).
6/24/16	Multiple Myeloma Response Criteria	Add	Added information box: Urine Studies In order to report a Stringent Complete Remission or Complete Remission, urine studies MUST be performed and agree with the international working group criteria provided above. Urine electrophoresis and immunofixation studies may not be performed in all cases. The disease response options below (Near Complete Remission, Very Good Partial Response, and Partial Response) may still be reported even if urine studies were never obtained or were only obtained at diagnosis. If urine studies were performed following the most recent line of therapy, the results must agree with the international working group criteria for the disease status being reported. In any case, serum studies MUST be performed and agree with the international working group criteria for the disease status being reported.
6/24/16	Multiple Myeloma Response Criteria	Add	Added link to Appendix W below disease status criteria.
6/24/16	MDS/MPN Response Criteria	Add	Added information box to MDS Disease Status Criteria, Hematologic Improvement Section: Hypomethylating agents (e.g. Vidaza) should not be considered cytotoxic therapy; therefore, Hematologic Improvement may still be reported if the recipient meets the criteria below while continuing to receive hypomethylating agents.
6/24/16	MDS/MPN Response Criteria	Modify	Added language to note beneath Progression from Hematologic Improvement for MDS and MPN Response Criteria: If the above criteria for progression have been met, but a hematologic improvement was not previously achieved, report “No Response (NR) / Stable Disease (SD)”.
6/24/16	MDS/MPN Response Criteria	Add	Added language to MPN Disease Status Criteria, Hematologic Improvement: Requires one measurement of the following maintained for at least eight weeks without ongoing cytotoxic therapy:
6/24/16	2014: MDS/MPN Pre-HCT	Add	Added information box to Q157: “Never Treated” is not an option choice on revision three of the Myelodysplasia / Myeloproliferative Disorders Pre-HSCT Data (MDS) Form. When completing revision three of this form, centers should report “No Response (NR) / Stable Disease (SD)” for recipients who have only received supportive care prior to transplant.
6/24/16	2400: Pre-TED	Add	Added information box to Q568: “Never Treated” is not an option choice on revision four of the Pre-TED Form. When completing revision four of this form, centers should report “No Response (NR) / Stable Disease (SD)” for recipients who have only received supportive care prior to transplant.

April 2016

Date	Manual Section	Add/Remove/Modify	Description
4/6/16	2814: Indication for CRID Assignment	Add	Added the following warning box to the 2814 topic: Reporting a subsequent transplant using the indication form is not allowed. Report the subsequent transplant on the latest follow up form for the most recent transplant.
4/6/16	2800: Log of Appended Documents	Add	Added the following information box: New FormsNet3 feature: The ‘Attachment’ feature of FormsNet3 allows users to attach documents directly to a form. Direct attachment to the form eliminates the need to fax/scan documents separately with a 2800 form. Training on this feature is available here: https://www.cibmtr.org/DataManagement/TrainingReference/FormsNet/Documents/FN3%20Training%20Guide%20AE.pdf
4/6/16	2400: Pre-TED	Modify	Updated donor section reflect reporting of different products from same donor in questions 46-50: Previous CIBMTR forms required you to enter two instances of the donor section when a single donor donated multiple products. This is no longer required. Report all products collected from a single donor in the same instance of the donor section. If the recipient receives a cord blood unit and another product from the same related donor, complete two instances of the Donor Information section (questions 31-62) on the Pre-TED Form 2400. For example, if a related donor gave a cord blood unit and bone marrow, you would report the cord blood unit information in one instance with the donor type listed as ‘Related cord blood unit’. Create another instance with the donor type reported as ‘Related donor’ to report the bone marrow information. This allows CIBMTR to capture all the necessary donor information needed. For these cases, complete a Form 2004 for each product. When the donor type is an HLA matched or mismatched relative, only one Form 2005 is required.
4/6/16	2450: Post-TED	Modify	Changed the wording in questions 66-73 to reflect the possibility of multiple causes of death (i.e., select all that apply), rather than a single primary cause of death.

March 2016

Date	Manual Section	Add/Remove/Modify	Description
3/31/16	Appendix R: Cytogenetic Abbreviations and Terminology	Add	Added the following text to Appendix R: The website Human Gene Nomenclature Committee or Genenames.org may be helpful in deciphering common cytogenetic abnormalities.
3/31/16	2014: MDS/MPN Pre-HCT	Add	Added an information box about transformation of polycythemia vera and essential thrombocythemia to question 123 : Myelofibrosis that develops in patients with essential thrombocythemia (ET) or polycythemia vera (PV) is considered secondary myelofibrosis. Do not report this as a transformation; when a patient with ET or PV develops fibrosis, do not report primary myelofibrosis as the primary indication for transplant.
3/31/16	2400: Pre-TED	Add	Added an information box about transformation of polycythemia vera and essential thrombocythemia to question 525: Myelofibrosis that develops in patients with essential thrombocythemia (ET) or polycythemia vera (PV) is considered secondary myelofibrosis. Do not report this as a transformation; when a patient with ET or PV develops fibrosis, do not report primary myelofibrosis as the primary indication for transplant.
3/31/16	2100: 100 Days Post-HCT	Add	Added the following informational text to question 74: The CD20+ data field can capture CD19+ or CD20+ cells
3/31/16	2200: Six Months to Two Years Post-HCT	Add	Added the following informational text to question 46: The CD20+ data field can capture CD19+ or CD20+ cells
3/31/16	2118: LYM Post-HCT	Add	Added informational box for questions 35-36: Questions 35 and 36 are meant to refer to the PET or PET/CT scan at relapse.
3/31/16	2016: PCD Pre-HCT	Add	Added information box to question 188: If this form is being completed for a second or subsequent transplant for relapse or progression of the same disease, report all therapy given for relapse or progression of disease. Do not report maintenance therapy given after the prior transplant, as this will be captured on the post-transplant disease inserts associated with the prior transplant.
3/31/16	2016: PCD Pre-HCT	Modify	Changed disease characteristics for plasma cell leukemia in question 1 to: more than ≥ 20% plasma cells in the peripheral differential white blood cell count
3/31/16	2400: Pre-TED	Modify	Changed disease characteristics for plasma cell leukemia in question 589 to: more than ≥ 20% plasma cells in the peripheral differential white blood cell count
3/31/16	2400: Pre-TED	Modify	Added table explaining how to report IgG versus IgM CMV results to question 93. [see table in text]
3/31/16	2000: Recipient Baseline	Modify	Added table explaining how to report IgG versus IgM CMV results to question 65. [see table in text]

February 2016

Date	Manual Section	Add/Remove/Modify	Description
2/16/16	2100: 100 Days Post-HCT	Add	Added Codes for Indication of Therapy Table for questions 9-33. [see table in text]
2/9/16	2400: Pre-TED	Modify	Modified text in obesity comorbidity to include pediatric patients: Obesity: Patients with a body mass index > 35 kg/m2 or BMI-for-age ≥ 95% (pediatric recipients only) during pre-transplant work-up period.
2/9/16	2131: ID Post-HCT 2133: WAS Post-HCT	Add	Added CD15+ cells to the text in question 171 [2131] and question 173 [2133]: Myeloid subsets may be reported as CD15+ or CD33+ on the laboratory report.
2/9/16	2450: Post-TED 2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT 2300: Greater Than Two Years Post-HCT	Modify	Modified pediatric acute GVHD Gut guidelines to questions 15 [2450], 151 [2100], 92 [2200], and 22 [2300]. See table for details.
2/9/16	2400: Pre-TED	Modify	Changed the text of question 53 to: Report the total number of mobilization events performed for this HCT. Include all mobilization events, even if a product from the mobilization event for this HCT was not used during the transplant. For example, if 2 mobilization events were performed to collect enough stem cells for this transplant, but the first collection wasn’t necessary for the transplant, report two mobilization events.
2/9/16	Appendix V: Multiple Myeloma – Defining What Baseline to Use When Determining Disease Status	Modify	Changed title of Appendix V: Multiple Myeloma – Defining What Baseline to Use When Determining The Best Response to HCT to Appendix V: Multiple Myeloma – Defining What Baseline to Use When Determining Disease Status

January 2016

Date	Manual Section	Add/Remove/Modify	Description
1/22/16	2450: Post-TED 2100: 100 Days Post-HCT 2200: Six Months to Two Years Post-HCT 2300: Greater Than Two Years Post-HCT	Modify	Updated footnote 4 below acute GVHD staging and grading table: Persistent nausea with or without histologic evidence of GVHD in the stomach or duodenum.
1/19/16	Multiple Myeloma Response Criteria	Add	Added the following text to CR: The method of the two consecutive assessments may be any of the biochemical tests (urine/serum testing) listed in the disease status criteria available in the manual. Though it is preferable the biochemical confirmatory testing include both the urine & serum, this disease status does not require two consecutive assessments by each method. As an example: [see in text]

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