Multiple MyelomaNCT03638232
Myeloma Treatment in Real Life
An observational study of Multiple Myeloma, run by University Hospital, Toulouse.
Trial summary
As part of an oral treatment regimen in ambulatory practice, certain uses in connection with drug consumption associated could alter treatment outcomes observed in randomized clinical trials. 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?
- Administrative data, Medical data and Drug exposition data
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to 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: Patients with multiple myeloma in Midi-Pyrénées
Who may be able to join
- Beneficiaries or entitled to health insurance or covered by the national system of information of health insurance
- Identified as multiple myeloma
- Incident patient : Subject presenting none of inclusion criteria during the 6 months observation period
Who cannot join
- Non incident patient : Subject presenting at least one of inclusion criteria during the 6 months observation period
About this study
Official title: Myeloma Treatment in Real Life : Pharmacoepidemiological Approach in Midi-pyrénées
As part of an oral treatment regimen in ambulatory practice, certain uses in connection with drug consumption associated could alter treatment outcomes observed in randomized clinical trials.
The increase in progression-free survival in myeloma may be accompanied by an impaired quality of life and a resurgence of pain symptoms over time, which could potentially lead to medication overuse involving painkillers but also psychotropic drugs. These combined consumption may affect survival through mechanisms of pharmacological or non-pharmacological interactions.
As part of this project, we wish to explore the scheme of adherence to myeloma drugs, and thus validate the decision diagram of hypothesis of not adequate of drug use in ambulatory conditions, from observational data. This discrepancy could result from poor adherence or suboptimal drug use but also from concomitant exposures to other drugs which may interact with myeloma. Before considering a study of greater magnitude that could address the consequences of non optimal drug use on clinical response criteria, such as duration of response or survival, it seems appropriate to confirm these assumptions within ' an exploratory study.
- Conditions
- Multiple Myeloma
- Being tested
- Administrative data, Medical data, Drug exposition data
- Keywords
- Drug consumption, Response to treatment, Non optimal drug use
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administrative dataOther
Gender Birthdate Department and town of residence Date of death Affiliation to french Universal Health Coverage
Medical dataOther
Long term affection code, number and medical codification Date of onset and end of care Codification of medical acts and consultation (With common classification of medical acts)
Drug exposition dataOther
Speciality of prescribing physician CIP code of drug Name of speciality prescribed Date of deliverance Date of prescription Number of treatment box delivered
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple myeloma | Data to be collected are :
* Drug exposition data
* Administrative data
* Medical data Receives: Other: Administrative data; Other: Medical data; Other: Drug exposition data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance
Measured: Through the end of study (15 months)
Secondary outcomes (3)
Description deliverance scheme of treatment used in multiple myeloma as assessed by data collected in french national system of information of health insurance
Measured: Through the end of study (15 months)
Evaluation of respect of official recommendation related to observance in multiple myeloma treatment as assessed by expression of Medication Possession Ratio (MPR)
The Medication Possession Ratio (MPR) measure compliance of prescriber with official recommendations and the one for the patient in relation to the prescription by evaluating the difference between the quantities delivered and the theoretical quantities calculated in joining recommended intake scheme. It is estimated by the ratio of number of defined daily doses delivered over a given period and the number of theoretical defined daily doses if maximum observance
Measured: Through the end of study (15 months)
Description of care consumption in multiple myeloma as assessed by data collected in french national system of information of health insurance
Measured: Through the end of study (15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study startOct 2014
- Primary completionSep 2015
- Study 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 University Hospital, ToulouseThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lapeyre-Mestre Maryse, PHD, Study director, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638232
- Sponsor's protocol ID
- 14 7439 07
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloma Treatment in Real Life : Pharmacoepidemiological Approach in Midi-pyrénées
- ClinicalTrials.gov ID
- NCT03638232
- Acronym / sponsor ID
- 14 7439 07
- Conditions
- Multiple Myeloma
- Keywords
- Drug consumption, Response to treatment, Non optimal drug use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Aug 2018 (actual)
- 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.
As part of an oral treatment regimen in ambulatory practice, certain uses in connection with drug consumption associated could alter treatment outcomes observed in randomized clinical trials.
The increase in progression-free survival in myeloma may be accompanied by an impaired quality of life and a resurgence of pain symptoms over time, which could potentially lead to medication overuse involving painkillers but also psychotropic drugs. These combined consumption may affect survival through mechanisms of pharmacological or non-pharmacological interactions.
As part of this project, we wish to explore the scheme of adherence to myeloma drugs, and thus validate the decision diagram of hypothesis of not adequate of drug use in ambulatory conditions, from observational data. This discrepancy could result from poor adherence or suboptimal drug use but also from concomitant exposures to other drugs which may interact with myeloma. Before considering a study of greater magnitude that could address the consequences of non optimal drug use on clinical response criteria, such as duration of response or survival, it seems appropriate to confirm these assumptions within ' an exploratory study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple myeloma | – | Other: Administrative data, Other: Medical data, Other: Drug exposition dataData to be collected are : * Drug exposition data * Administrative data * Medical data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple myeloma in Midi-Pyrénées
Key inclusion criteria (3 listed)
- Beneficiaries or entitled to health insurance or covered by the national system of information of health insurance
- Identified as multiple myeloma
- Incident patient : Subject presenting none of inclusion criteria during the 6 months observation period
Key exclusion criteria (1 listed)
- Non incident patient : Subject presenting at least one of inclusion criteria during the 6 months observation period
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 |
|---|---|---|
| Administrative dataGender Birthdate Department and town of residence Date of death Affiliation to french Universal Health Coverage | Other | Patients with multiple myeloma |
| Medical dataLong term affection code, number and medical codification Date of onset and end of care Codification of medical acts and consultation (With common classification of medical acts) | Other | Patients with multiple myeloma |
| Drug exposition dataSpeciality of prescribing physician CIP code of drug Name of speciality prescribed Date of deliverance Date of prescription Number of treatment box delivered | Other | Patients with multiple myeloma |
Primary outcome
Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance
Time frame: Through the end of study (15 months)
3 secondary outcomes
Description deliverance scheme of treatment used in multiple myeloma as assessed by data collected in french national system of information of health insurance
Time frame: Through the end of study (15 months)
Evaluation of respect of official recommendation related to observance in multiple myeloma treatment as assessed by expression of Medication Possession Ratio (MPR)
Time frame: Through the end of study (15 months)
Description of care consumption in multiple myeloma as assessed by data collected in french national system of information of health insurance
Time frame: Through the end of study (15 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 20 Aug 2018.
- 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.
Lapeyre-Mestre Maryse, PHD study director
University Hospital of Toulouse
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by University Hospital, Toulouse.
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 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 20 Aug 2018. 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?
Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance (time frame: Through the end of study (15 months)). 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 Aug 2018.