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: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition Phase
Lymphoma
Multiple Myeloma
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry on a Cohort of Patients Receiving Plerixafor

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 9500
Study Start Date: January 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362972

Sponsors and Collaborators
Genzyme, a Sanofi Company
European Group for Blood and Marrow Transplantation
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01362972     History of Changes
Other Study ID Numbers: MOZ18009
Study First Received: May 27, 2011
Last Updated: August 22, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
JM 3100
Lenograstim
Adjuvants, Immunologic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014