NCT01362972

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,801

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

5.3 years

First QC Date

May 27, 2011

Last Update Submit

August 23, 2016

Conditions

LymphomaMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 31570781DERIVED

  • 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.

    PMID: 31534192DERIVED

  • 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.

    PMID: 29217776DERIVED

MeSH Terms

Conditions

LymphomaMultiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 1, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 24, 2016

Record last verified: 2016-08