Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry for Off-Label Transplant Use of Plerixafor

Completed

• Conditions: Solid Tumors; Plasma Cell Disorders; Acute Leukemia; Myeloproliferative Neoplasm; Chronic Leukemia; Myelodysplastic Syndrome; Lymphoma

• Registration Number: NCT01362985
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of plerixafor will be collected for data entered over a 5 year time span (i.e., data entered into the registry between the date of European Union (EU) marketing authorization \[31 July 2009\] and 31 July 2014).

The EBMT is a non-profit, scientific society representing more than 600 transplant centers mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy, which includes registering all the activity relating to stem cell transplants. Data are entered, managed, and maintained in a central database with internet access; each EBMT center is represented in this database.

The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor shall provide information of a substantial number of patients who are representative of the patient population receiving plerixafor off-label.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-06-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Patients treated with plerixafor who have 1 or more of the following:

• Background disease other than lymphoma or multiple myeloma (MM)
• Are younger than 18 years of age.
• Received transplant using ex vivo plerixafor-mobilised cells (umbilical cord cell, peripheral blood (PB), bone marrow (BM) cell collection)
• Received treatment with plerixafor alone (i.e., without granulocyte colony stimulating factor (G-CSF))
• Contraindication for G-CSF
• Transplants using plerixafor-mobilised cells from allogeneic donor
• Received transplant using plerixafor-mobilised bone marrow cells
• Routes of plerixafor administration other than subcutaneous
• Patients whose cells do not mobilize poorly
• Other

Exclusion Criteria

• Adults diagnosed with lymphoma or multiple myeloma (MM) and have been treated with plerixafor according to the European Union (EU) label.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration	5 years