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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Group for Blood and Marrow Transplantation
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01362972
First received: May 27, 2011
Last updated: February 5, 2014
Last verified: February 2014

May 27, 2011
February 5, 2014
January 2008
December 2015   (final data collection date for primary outcome measure)
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. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01362972 on ClinicalTrials.gov Archive Site
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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

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Patients with data reported to the EBMT who have lymphoma or multiple myeloma (MM) and who have undergone autologous haematopoietic stem cell (HSC) transplantation during the years 2008 up to and including 2012.

  • Lymphoma
  • Multiple Myeloma
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  • plerixafor + granulocyte colony stimulating factor (G-CSF)
    Patients who receive plerixafor+granulocyte colony stimulating factor (G-CSF) for the mobilisation of peripheral blood (PB) CD34+ cells and who have undergone autologous haematopoietic stem cell (HSC) transplantation.
  • plerixafor + G-CSF + chemotherapy
    Patients who receive plerixafor+granulocyte colony stimulating factor (G-CSF)+chemotherapy for the mobilisation of peripheral blood (PB) CD34+ cells and who have undergone autologous haematopoietic stem cell (HSC) transplantation.
  • granulocyte colony stimulating factor (G-CSF) + chemotherapy
    Patients who receive granulocyte colony stimulating factor (G-CSF) + chemotherapy for the mobilisation of peripheral blood (PB) CD34+ cells and who have undergone autologous haematopoietic stem cell (HSC) transplantation.
  • granulocyte colony stimulating factor (G-CSF) alone
    Patients who receive granulocyte colony stimulating factor (G-CSF) alone for the mobilisation of peripheral blood (PB) CD34+ cells and who have undergone autologous haematopoietic stem cell (HSC) transplantation.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9500
December 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01362972
MOZ18009
No
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
European Group for Blood and Marrow Transplantation
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP