Inside Oct 2015

Quick Links

On October 13, 2015, the CIBMTR hosted the 2015 Cellular Therapy Registry Forum. The attendees included representatives from Transplant Centers and their cell processing laboratories, Pharma, Industry, FDA and NIH/NCI.

The following topics were covered at the forum:
   Cell Therapy for Treatment of Viral Infection
      - Third Party CTLs
      - Genetic Modified Cells
   CAR-T cells for Malignancies
      - CD-19 constructs
      - Other Targets
   Other Cellular Therapies
      - NK cell infusion
      - MSC
   Manufacturing Models
   Regulatory Framework and Long Term Outcomes Reporting
   NCI - Cancer Immunotherapy Trials Network (CITN)
   Discussion and Commentary on the proposed CIBMTR
   Cellular Therapy Registry model
The discussion during the forum focused on what data needs to be collected, who should provide the data and what cellular therapy should the CIBMTR focus on first.
Currently the CIBMTR collects cellular therapy data on the Form 4000 or CTRM. It is a single stand-alone form without follow-up. It captures cellular therapy activity, and it incorporates limited outcome data related to infusion adverse events. 
Since its implementation, data for 534 patients who received cellular therapy for several indications were reported by 10 centers. The most common indication is the use of autologous cord blood unit for treatment of congenital neurologic disorders, mainly cerebral palsy and congenital hydrocephalus. 
In the future, the CIBMTR will be developing new forms to collect cellular data. The initial focus will be on CAR-T cell therapies. The new forms are tentatively scheduled for release in Summer 2016.

CIBMTR Data Operations
CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®/Be The Match® and Medical College of Wisconsin.
New eLearning this month
"FormsNet3 Recipient Application Training" 
This module, authored by Liz Johnson and Lori Colt, provides an explanation of the functions and features of the system that we use to collect and store HCT data. We recommend all new data managers complete this eLearning. It is approximately 20 minutes in length. You will find this eLearning in our Learning Center, under the category CIBMTR Data Management.
REVISED FormsNet3 Training Guide
This practical desk reference in PDF format is printable, with Recipient and Donor sections, as well as functionality that is the same for both. The Guide is located on the FormsNet3 page of the CIBMTR website. Content includes changes to the system since the launch of the application three years ago. 
"The font is small on the exams"
We received some comments about the font size for the exams in the Learning Center being too small. In response, you can modify that setting yourselves by holding down the CTRL key and press the + key while in the screen you want to change.  
Maximum attempts on eLearning exams
On two of our most recent eLearning modules, "Reporting Preparative Regimen" and "Infusion Data Reporting(Form 2006)", we placed a limit of two attempts as the maximum number of times that a data manager can take each module's exam. A score of 9 out of 10 correct answers, or 90%, is passing. After two attempts the module will lock and the eLearning module must be repeated. A couple of days before you want to retake the exam, email and you will be notified when the exam has been unlocked. We encourage data managers to contact their CRC if there is module content that they are finding difficult to understand. The purpose of training with testing is to ensure that data managers understand how to interpret the data they are submitting to CIBMTR. This in-turn will improve the collection and submission of consistently accurate data.
Question: Reporting reconstituted cord blood unit
On the revised Pre-TED (Form 2400) and HCT Infusion (Form 2006), both washed and diluted are captured as processing/manipulation methods. How would I report a reconstituted cord blood unit in these data fields?
Cord blood reconstitution is a no-wash dilution method. Therefore, it should be reported under 'dilution' in the processing and manipulation data fields. Another frequent scenario involves a cord blood unit marked as 'WASHED & DILUTED'. In this case, only 'wash' would be reported in the processing and manipulation data fields, since dilution is part of the wash process and therefore does not need to be separately reported. 

Question: Multiple myeloma complete remission (CR) criteria
According to the criteria for CR for multiple myeloma, the patient must have a normal serum free light chain ratio, if they have light chain disease.  If the ratio is low, is that considered a normal level?

A low kappa/lambda ratio is not considered normal.  A low ratio indicates a monoclonal gammopathy with bone marrow suppression, without bone marrow suppression or with renal impairment. In order to be considered in CR, a monoclonal gammopathy cannot be present.

Question:  Lambda light chain only disease
If the kappa/lambda ratio was normal, the urine IFE was negative and the bone marrow showed 1% plasma cells, can this patient be in a CR even if the Quant free lambda levels are high (i.e. 146 mg/L)?

The interpretation for a high lambda with a normal ratio is one of two things, either there's a polyclonal immunoglobulin increase, or renal impairment present.  In either case, the recipient would be in a CR.
Send your questions into The answer may be in a future newsletter.
Thank you to the contributors for this month's newsletter.
CIBMTR Training