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

Monitoring of Plerixafor Off-Label Use in the European Group for Blood and Bone Marrow Transplantation (EBMT) Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01362985

Enrollment

201

Registered

2011-06-01

Start date

2009-07-31

Completion date

2014-07-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Chronic Leukemia, Lymphoma, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Plasma Cell Disorders, Solid Tumors

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results