Multiple MyelomaMOZOBILNCT02997813
Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies
An observational study of Multiple Myeloma and Blood Stem Cell Transplant Failure, run by Intergroupe Francophone du Myelome at 9 sites in France.
Trial summary
This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Blood Stem Cell Transplant Failure
- How many people
- 112 participants
- Where
- 9 sitesFrance
- Study dates
- Jun 2015to Dec 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: The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy. All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.
Who may be able to join
- Hematology patients diagnosed with Multiple Myeloma who are candidates for autologous hematopoietic stem cell transplantation (ASCT) upfront.
- Age > 18 years
- Undergone prior successful peripheral blood stem cell mobilization with Cyclophosphamid or Plerixafor
Who cannot join
- Age < 18 years;
- Primary diagnosis other than Multiple Myeloma
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHRU Dijon
Dijon, 21000
Centre Hospitalier Universitaire (CHU) de Limoges
Limoges, 87042
Centre Hospitalier Lyon Sud
Lyon, 69495
CHRU Hôtel Dieu
Nantes, 44035
Institut Curie Centre de Lutte Contre le Cancer (CLCC)
Paris, 75005
La Pitié Salpetriêre
Paris, 75013
Hôpital Saint-Antoine
Paris, 75571
Hôpital Robert Debré Hématologie
Reims, 51092
Centre Henri Becquerel
Rouen, 76038
About this study
Official title: Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor
This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Patient records will be divided into two groups of 50 patients minimum, maximum 100 patients or up to the number of patient records that could be extracted. The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy.
All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.
All data that will be analyzed will be extracted from the selected IFM institutions which are located in France.
- Medical subject headings
- 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 |
|---|---|---|
| Cohort 1 | All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor | |
| Cohort 2 | All consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cost of stem cell mobilization procedure (including remobilisation if applicable)
Measured: 2009-2013
Secondary outcomes (5)
Number of visits for administration of mobilizing agents
Measured: 2009-2013
Duration (days) of administration of mobilizing agents
Measured: 2009-2013
Agents used as mobilizing agents
Measured: 2009-2013
Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg)
Measured: 2009-2013
Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg)
Measured: 2009-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone du Myelome
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Xavier Leleu, Dr, Study chair, Service des maladies du sang, Hôpital Huriez, CHRU, LilleDenis Caillot, Dr, Study director, Service d'Hématologie Clinique, Hôpital Le Bocage, CHU DijonEric Deconinck, Pr, Study director, Hématologie, Hôpital Jean Minjoz, CHU BesançonSamuel Limat, Pr, Study director, Pharmacie centrale, Hôpital Jean Minjoz, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997813
- Sponsor's protocol ID
- IFM2014-05
- Acronym
- MOZOBIL
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor
- ClinicalTrials.gov ID
- NCT02997813
- Acronym / sponsor ID
- MOZOBIL / IFM2014-05
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Intergroupe Francophone du MyelomeResearch network
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Dec 2016 (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.
This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Patient records will be divided into two groups of 50 patients minimum, maximum 100 patients or up to the number of patient records that could be extracted. The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy.
All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.
All data that will be analyzed will be extracted from the selected IFM institutions which are located in France.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor |
| Cohort 2 | – | –All consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy. All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.
Key inclusion criteria (3 listed)
- Hematology patients diagnosed with Multiple Myeloma who are candidates for autologous hematopoietic stem cell transplantation (ASCT) upfront.
- Age > 18 years
- Undergone prior successful peripheral blood stem cell mobilization with Cyclophosphamid or Plerixafor
Key exclusion criteria (2 listed)
- Age < 18 years;
- Primary diagnosis other than Multiple Myeloma
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
Total cost of stem cell mobilization procedure (including remobilisation if applicable)
Time frame: 2009-2013
5 secondary outcomes
Number of visits for administration of mobilizing agents
Time frame: 2009-2013
Duration (days) of administration of mobilizing agents
Time frame: 2009-2013
Agents used as mobilizing agents
Time frame: 2009-2013
Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg)
Time frame: 2009-2013
Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg)
Time frame: 2009-2013
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 20 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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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.
Xavier Leleu, Dr study chair
Service des maladies du sang, Hôpital Huriez, CHRU, Lille
Denis Caillot, Dr study director
Service d'Hématologie Clinique, Hôpital Le Bocage, CHU Dijon
Eric Deconinck, Pr study director
Hématologie, Hôpital Jean Minjoz, CHU Besançon
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Blood Stem Cell Transplant Failure, run by Intergroupe Francophone du Myelome at 9 sites 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 3 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 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Total cost of stem cell mobilization procedure (including remobilisation if applicable) (time frame: 2009-2013). 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 20 Dec 2016.