Multiple MyelomaPLERIXAFORNCT02861287
Economic Evaluation of the Use of Plerixafor for Autologous HSC Transplantation for Multiple Myeloma
An observational study of Multiple Myeloma, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Economic evaluation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2015
- 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 study will retrospectively review 60 electronic health records of patients who underwent peripheral blood stem cell mobilization for Multiple Myeloma, and who failed to achieve efficient and clinically meaningful mobilization in response to a well-conducted "G-CSF alone" regimen.
Who may be able to join
- Adult patients diagnosed with Multiple Myeloma who were eligible for high-dose melphalan supported with autologous hematopoietic stem cell transplantation (HSCT) as part of their treatment plan
- First mobilization attempt
- "rhG-CSF alone" mobilization regimen
- Failed mobilization as documented by an increase in CD34+ cell mobilization deemed insufficient to initiate apheresis (below 15/µL), after the 4 first injections of rhG-CSF that are administered in the evening
Who cannot join
- Age < 18 years;
- Primary diagnosis other than MM
- 2nd or subsequent mobilization attempt
- Patients who previously received HDCT + autologous HSCT
- Chemotherapy-based mobilization regimen
- Efficient mobilization, allowing for apheresis and collection of the target cell number (5x106 CD34+ cells/kg for every planned autologous transplantation as per institutional SOPs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Economic Evaluation of the Use of Plerixafor for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone.
- Conditions
- Multiple Myeloma
- Being tested
- Economic evaluation
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Economic evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | patients with Multiple Myeloma who underwent PBSC mobilization since December 2009 and who received plerixafor in line with inclusion criteria Receives: Other: Economic evaluation | |
| Historical cohort | patients with Multiple Myeloma who underwent PBSC mobilization immediately prior to marketing authorization and clinical utilization of Plerixafor which is before December 2009 (over the 2007-2009 period) Receives: Other: Economic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness analysis
The cost-effectiveness analysis will be performed using the collection of a transplantable graft as effectiveness criteria; the suitability of collected cell products for transplantation will be judged as per institutional criteria.
Direct medical costs will be estimated by micro-costing, i.e. by measuring physical quantities (capital and labor) consumed for each patient and attributing corresponding monetary costs on the basis of average French prices. Costs (including room - inpatient and outpatient, drugs and laboratory tests) will be estimated on the basis of patients' medical records.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
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.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Chabannon, MD PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861287
- Sponsor's protocol ID
- PLERIXAFOR-IPC 2013-002
- Acronym
- PLERIXAFOR
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 10 Aug 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 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of the Use of Plerixafor for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02861287
- Acronym / sponsor ID
- PLERIXAFOR / PLERIXAFOR-IPC 2013-002
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- First posted
- 10 Aug 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 study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Other: Economic evaluationpatients with Multiple Myeloma who underwent PBSC mobilization since December 2009 and who received plerixafor in line with inclusion criteria |
| Historical cohort | – | Other: Economic evaluationpatients with Multiple Myeloma who underwent PBSC mobilization immediately prior to marketing authorization and clinical utilization of Plerixafor which is before December 2009 (over the 2007-2009 period) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will retrospectively review 60 electronic health records of patients who underwent peripheral blood stem cell mobilization for Multiple Myeloma, and who failed to achieve efficient and clinically meaningful mobilization in response to a well-conducted "G-CSF alone" regimen.
Key inclusion criteria (4 listed)
- Adult patients diagnosed with Multiple Myeloma who were eligible for high-dose melphalan supported with autologous hematopoietic stem cell transplantation (HSCT) as part of their treatment plan
- First mobilization attempt
- "rhG-CSF alone" mobilization regimen
- Failed mobilization as documented by an increase in CD34+ cell mobilization deemed insufficient to initiate apheresis (below 15/µL), after the 4 first injections of rhG-CSF that are administered in the evening
Key exclusion criteria (6 listed)
- Age < 18 years;
- Primary diagnosis other than MM
- 2nd or subsequent mobilization attempt
- Patients who previously received HDCT + autologous HSCT
- Chemotherapy-based mobilization regimen
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 |
|---|---|---|
| Economic evaluation | Other | Historical cohort, Study cohort |
Primary outcome
Cost-effectiveness analysis
Time frame: 1 year
The cost-effectiveness analysis will be performed using the collection of a transplantable graft as effectiveness criteria; the suitability of collected cell products for transplantation will be judged as per institutional criteria. Direct medical costs will be estimated by micro-costing, i.e. by measuring physical quantities (capital and labor) consumed for each patient and attributing corresponding monetary costs on the basis of average French prices. Costs (including room - inpatient and outpatient, drugs and laboratory tests) will be estimated on the basis of patients' medical records.
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 10 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Christian Chabannon, MD PhD principal investigator
Institut Paoli-Calmettes
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 Multiple Myeloma, run by Institut Paoli-Calmettes 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 4 inclusion and 6 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 10 Aug 2016. 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?
Cost-effectiveness analysis (time frame: 1 year). 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 10 Aug 2016.