LymphomaNCT01362972
Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry on a Cohort of Patients Receiving Plerixafor
An observational study of Lymphoma and Multiple Myeloma, run by Genzyme, a Sanofi Company.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Multiple Myeloma
- How many people
- 7,801 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
About this study
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.
Read more
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.
- Conditions
- Lymphoma, Multiple Myeloma
- Medical subject headings
- Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Society for Blood and Marrow Transplantation
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362972
- Sponsor's protocol ID
- MOZ18009
- Other IDs
- OBS13611
- Status last verified
- Aug 2016
- First submitted
- 27 May 2011
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31570781Morris 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.
PubMed 31534192Auner 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.
PubMed 29217776
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry on a Cohort of Patients Receiving Plerixafor
- ClinicalTrials.gov ID
- NCT01362972
- Acronym / sponsor ID
- MOZ18009
- Conditions
- Lymphoma, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,801 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- European Society for Blood and Marrow Transplantation
- Study start
- Mar 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Derived from this study: PubMed 31570781Sureda 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.
- Derived from this study: PubMed 31534192Morris 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.
- Derived from this study: PubMed 29217776Auner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Multiple Myeloma, run by Genzyme, a Sanofi Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01362972, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.