Clinical trial NCT03638232: Myeloma Treatment in Real Life
Official title: Myeloma Treatment in Real Life : Pharmacoepidemiological Approach in Midi-pyrénées
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Drug consumption
Response to treatment
Non optimal drug use
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple myeloma in Midi-Pyrénées

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Non incident patient : Subject presenting at least one of inclusion criteria during the 6 months observation period

Primary outcomes:
measure: Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance
timeFrame: Through the end of study (15 months)
Secondary outcomes:
measure: Description deliverance scheme of treatment used in multiple myeloma as assessed by data collected in french national system of information of health insurance
timeFrame: Through the end of study (15 months)
measure: Evaluation of respect of official recommendation related to observance in multiple myeloma treatment as assessed by expression of Medication Possession Ratio (MPR)
timeFrame: Through the end of study (15 months)
measure: Description of care consumption in multiple myeloma as assessed by data collected in french national system of information of health insurance
timeFrame: Through the end of study (15 months)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Toulouse
name: Lapeyre-Mestre Maryse, PHD
role: STUDY_DIRECTOR
References: