The Plasma Cell Disorder Pre-Infusion Data Form (Form 2016) is one of the Comprehensive Report Forms. This form captures PCD-specific pre-infusion data such as: disease classification at diagnosis, hematologic findings at the time of diagnosis and prior to the start of the preparative regimen, amyloidosis organ involvement at diagnosis and prior to the start of the preparative regimen, pre-HCT treatments administered and the best response to each line of therapy, and disease status prior to the start of the preparative regimen.
This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as “Multiple myeloma/plasma cell disorder (PCD).”
Report “no” and go to question 1 in any of the following scenarios:
- This is the first infusion reported to the CIBMTR; or
- This is a second, or subsequent, transplant for a different disease (e.g., the patient was previously transplanted for a disease other than a Plasma Cell Disorder/Multiple Myeloma); or
- This is a second, or subsequent, infusion for the and this (e.g., the patient was on the TED track for the prior infusion, prior infusion was autologous with no consent, etc.).
Report “yes” and go to question 157 in any of the following scenarios:
- This is a second, or subsequent, transplant for ; or
- This is an infusion for the , and this .
Q1-2: Disease Assessment at Diagnosis
Q3-60: Laboratory Studies at Diagnosis
Q61-124: Amyloidosis Organ Involvement at Diagnosis
Q125-156: POEMS Syndrome Assessment at Diagnosis
Q157-187: Pre-HCT Therapy
Q188-255:Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen
Q256-290: Amyloidosis Organ Involvement at Last Evaluation Prior to the Start of the Preparative Regimen
Q291-296:Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
|10/23/2020||2016: PCD Pre-Infusion||Modify||Provided clarification and additional examples on how to report next generation flow (NGF) in questions 225-228.|
|10/7/2020||2016: PCD Pre-Infusion||Modify|| Clarification updated to provide instructions on how to report lines of therapy for subsequent infusions to be consistent:
If this is a subsequent infusion and a 2016 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2016. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2016 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
|5/8/2020||2016: PCD Pre-Infusion||Add||Added guidance for question 139-140 to document unit of measure to the nearest tenth.|
|5/8/2020||2016: PCD Pre-Infusion||Add||Added guidance for question 142-143 to document unit of measure to the nearest tenth.|
|5/7/2020||2016: PCD Pre-Infusion||Add||Added guidance for question 192: “Question 192 is disabled and should not be answered. This question will be removed when the form is next revised”.|
|3/27/2020||2016: PCD Pre-Infusion||Modify||Modified sentence referring reader to question 188 for POEMS syndrome to recipient having a primary disease of monoclonal gammopathy of renal significance (MGRS) in the section Q157-187: Pre-HCT Therapy.|
|3/23/2020||2016: PCD Pre-Infusion||Add||Added guidance on LV straing percentage to questions 77-78 and 262-263.|
|1/24/2020||2016: PCD Pre-Infusion||Modify||Version 3 of the 2016: Plasma Cell Disorders (PCD) Pre-Infusion Data section of the Forms Instruction Manual released. Version 3 corresponds to revision 4 of the Form 2016.|
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