Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry on a Cohort of Patients Receiving Plerixafor
NCT ID: NCT01362972
Last Updated: 2016-08-24
Study Results
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Basic Information
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COMPLETED
7801 participants
OBSERVATIONAL
2011-03-31
2016-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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 whose graft product underwent ex vivo manipulation will be excluded from analysis
18 Years
ALL
No
Sponsors
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European Society for Blood and Marrow Transplantation
NETWORK
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
References
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Sureda A, Chabannon C, Masszi T, Pohlreich D, Scheid C, Thieblemont C, Wahlin BE, Sakellari I, Russell N, Janikova A, Dabrowska-Iwanicka A, Touzeau C, Esquirol A, Jantunen E, van der Werf S, Bosman P, Boumendil A, Liu Q, Celanovic M, Montoto S, Dreger P. Analysis of data collected in the European Society for Blood and Marrow Transplantation (EBMT) Registry on a cohort of lymphoma patients receiving plerixafor. Bone Marrow Transplant. 2020 Mar;55(3):613-622. doi: 10.1038/s41409-019-0693-z. Epub 2019 Sep 30.
Morris C, Chabannon C, Masszi T, Russell N, Nahi H, Kobbe G, Krejci M, Auner HW, Pohlreich D, Hayden P, Basak GW, Lenhoff S, Schaap N, van Biezen A, Knol C, Iacobelli S, Liu Q, Celanovic M, Garderet L, Kroger N. Results from a multicenter, noninterventional registry study for multiple myeloma patients who received stem cell mobilization regimens with and without plerixafor. Bone Marrow Transplant. 2020 Feb;55(2):356-366. doi: 10.1038/s41409-019-0676-0. Epub 2019 Sep 18.
Auner HW, Iacobelli S, Sbianchi G, Knol-Bout C, Blaise D, Russell NH, Apperley JF, Pohlreich D, Browne PV, Kobbe G, Isaksson C, Lenhoff S, Scheid C, Touzeau C, Jantunen E, Anagnostopoulos A, Yakoub-Agha I, Tanase A, Schaap N, Wiktor-Jedrzejczak W, Krejci M, Schonland SO, Morris C, Garderet L, Kroger N. Melphalan 140 mg/m2 or 200 mg/m2 for autologous transplantation in myeloma: results from the Collaboration to Collect Autologous Transplant Outcomes in Lymphoma and Myeloma (CALM) study. A report by the EBMT Chronic Malignancies Working Party. Haematologica. 2018 Mar;103(3):514-521. doi: 10.3324/haematol.2017.181339. Epub 2017 Dec 7.
Other Identifiers
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OBS13611
Identifier Type: OTHER
Identifier Source: secondary_id
MOZ18009
Identifier Type: -
Identifier Source: org_study_id
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