2016: PCD Pre-Infusion

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).”

Subsequent Transplant

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 same disease subtype and this baseline disease insert was not completed for the previous transplant (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 relapse or progression of the same disease; or
• This is an infusion for the same disease, and this baseline PCD disease insert was completed previously.
  

Links to Sections of the Form
Q1 – 2: Disease Assessment at Diagnosis
Q3 – 60: Diagnostic Studies
Q61 – 124: Amyloidosis Organ Involvement at Diagnosis
Q125 – 156: POEMS Syndrome Assessment at Diagnosis
Q157 – 187: Pre-Infusion Therapy
Q188 – 254: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
Q255 – 289: Amyloidosis Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
Q290 – 295: POEMS Syndrome Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Manual Updates:
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.

If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals webpage.

Date	Manual Section	Add/Remove/Modify	Description
6/28/2023	2016: PCD Pre-Infusion	Add	The Reporting Prior Cellular Therapy as a Line of Therapy blue information box added to Q181: As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion is no longer required to be reported as a line of therapy on the pre-infusion disease specific form
5/1/2023	2016: PCD Pre-Infusion	Modify	Instructions above Q3 updated: For questions 3-60, report values obtained at diagnosis or prior to the first treatment for the plasma cell disorder for which the transplant was performed. If testing is performed multiple times prior to the start of the first treatment, report the last test before the start of treatment testing performed closest to the diagnosis date.
10/17/2022	2016: PCD Pre-Infusion	Add	Q181 updated for clarification: Cellular therapy treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g., cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g., CAR-T cells). Report Yes if the recipient received cellular therapy as part of the line of therapy being reported. For subsequent infusions, this includes any previous cell therapy infusions to treat disease already reported to the CIBMTR. If not, report No.
4/30/2021	2016: PCD Pre-Infusion	Modify	Version 4 of the 2016: Plasma Cell Disorders (PCD) Pre-Infusion Data section of the Forms Instruction Manual released. Version 4 corresponds to revision 5 of the Form 2016.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.