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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Multiple Myeloma

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

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.

Outcome Time Frame:

5 Years

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

European Union: European Medicines Agency

Study ID:

MOZ18009

NCT ID:

NCT01362972

Start Date:

January 2008

Completion Date:

December 2016

Related Keywords:

  • Lymphoma
  • Multiple Myeloma
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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