Bone Marrow / Autologous TransplantsNCT01738373
Registry of Patients Treated With Plerixafor (Mozobil®) for Haematopoietic Stem Cell Mobilization Before Autologous Transplantation
An observational study of Bone Marrow / Autologous Transplants, run by Genzyme, a Sanofi Company at 1 site in France.
Trial summary
The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Marrow / Autologous Transplants
- What is being tested?
- Plerixafor
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Nov 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The selection of the registry's participants will be based on an exhaustive request of all apheresis centers distributed in the French territory.
Who may be able to join
- Patients treated with Plerixafor for autologous transplantation between November 2011 and November 2012
- Patients who have been informed and who have given their written consent for the access to their medical file
Who cannot join
- Patients already included in a Plerixafor ongoing clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigator Centers Will Be All French Hematology Centers Performing Autologous Transplantation and Prescribing Mozobil in Hematopoietic Stem Cell Mobilization Willing to Participate In This Study
The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request.
- Conditions
- Bone Marrow / Autologous Transplants
- Being tested
- Plerixafor
- Keywords
- autologous stem cell transplantation, 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.
PlerixaforDrug
Also called Mozobil®
Plerixafor will be prescribed independently by the physician, according to usual practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
The characteristics of the patients who received treatment
Measured: 13 months
Dosage of treatment
Measured: 13 months
Number of CD34+ cells collected following treatment
Measured: 13 months
Number of patients with the existence of one or more predictive factors of poor mobilisation
Measured: 13 months
Duration of treatment
Measured: 13 months
Associated treatments
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow / Autologous TransplantsStudies 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
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738373
- Sponsor's protocol ID
- MOZ22510
- Status last verified
- Mar 2015
- First submitted
- 26 Nov 2012
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Centers Will Be All French Hematology Centers Performing Autologous Transplantation and Prescribing Mozobil in Hematopoietic Stem Cell Mobilization Willing to Participate In This Study
- ClinicalTrials.gov ID
- NCT01738373
- Acronym / sponsor ID
- MOZ22510
- Conditions
- Bone Marrow / Autologous Transplants
- Keywords
- autologous stem cell transplantation, lymphoma, multiple myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Nov 2012 (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.
The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The selection of the registry's participants will be based on an exhaustive request of all apheresis centers distributed in the French territory.
Key inclusion criteria (2 listed)
- Patients treated with Plerixafor for autologous transplantation between November 2011 and November 2012
- Patients who have been informed and who have given their written consent for the access to their medical file
Key exclusion criteria (1 listed)
- Patients already included in a Plerixafor ongoing clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlerixaforAlso: Mozobil®Plerixafor will be prescribed independently by the physician, according to usual practice. | Drug | – |
Primary outcome
The characteristics of the patients who received treatment
Time frame: 13 months
Dosage of treatment
Time frame: 13 months
Number of CD34+ cells collected following treatment
Time frame: 13 months
Number of patients with the existence of one or more predictive factors of poor mobilisation
Time frame: 13 months
Duration of treatment
Time frame: 13 months
Associated treatments
Time frame: 13 months
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 23 Mar 2015.
Related trials for Bone Marrow / Autologous Transplants
Active, not recruitingPhase 3
UARK 2006-66, Total Therapy 3B: An Extension of UARK 2003-33 Total Therapy
Multiple Myeloma
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow / Autologous Transplants, run by Genzyme, a Sanofi Company at 1 site in France.
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 2 inclusion and 1 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The characteristics of the patients who received treatment (time frame: 13 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2015.