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Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry on a Cohort of Patients Receiving Plerixafor

Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry on a Cohort of Patients Receiving Plerixafor

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01362972
Enrollment
7801
Registered
2011-06-01
Start date
2011-03-31
Completion date
2016-06-30
Last updated
2016-08-24

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

Conditions

Lymphoma, Multiple Myeloma

Brief summary

In the European Union (EU), plerixafor is indicated in combination with granulocyte colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells (HSCs) to the peripheral blood (PB) for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma (MM) whose cells mobilise poorly. This is a clinical outcome analysis of a prospectively defined cohort of patients with data reported retrospectively to the European Group for Blood and Marrow Transplantation (EBMT) who have lymphoma or multiple myeloma (MM), whose cells mobilize poorly, and who have undergone autologous haematopoietic stem cell (HSC) transplantation during the years 2008 up to and including 2012. 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 analysis of data from a well established registry like the EBMT registry allows for follow up of a large number of patients who are representative of the patient population receiving plerixafor.

Interventions

None listed

Sponsors

European Society for Blood and Marrow Transplantation
CollaboratorNETWORK
Genzyme, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

For inclusion in the cohort analysis, patients must have data in the EBMT registry that meet the following criteria: * Adults diagnosed with lymphoma or multiple myeloma (MM) * Received first autologous transplants of peripheral blood (PB) non ex-vivo manipulated stem cells in the time period listed above using cells mobilised with one of the following regimens: * plerixafor plus granulocyte colony stimulating factor (G-CSF) * plerixafor plus G-CSF plus chemotherapy * G-CSF alone or * G-CSF plus chemotherapy Note: Patients included in the plerixafor groups will be those treated according to the label * Provision of informed consent (i.e., all patients with data in the EBMT registry will have signed consent at the time of transplantation for the potential use of their data for analysis)

Exclusion criteria

* Patients treated with plerixafor NOT according to the European Union (EU) label. * Patients whose graft product underwent ex vivo manipulation will be excluded from analysis

Design outcomes

Primary

MeasureTime frame
Compare PFS, OS, and Relapse in EBMT-registered autoHSC transplant patients between 2008 and 2012, with HSCs mobilized with Plerixafor + G-CSF vs other regimens.5 Years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026