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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362972
• Other study ID #: MOZ18009
• Secondary ID: OBS13611
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: August 23, 2016
• Start date: March 2011
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7801
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company	European Group for Blood and Marrow Transplantation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No