NCT03638232

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

August 16, 2018

Last Update Submit

August 17, 2018

Conditions

Multiple Myeloma

Keywords

Drug consumptionResponse to treatmentNon optimal drug use

Outcome Measures

Primary Outcomes (1)

  • Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance

    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

    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)

    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

    Through the end of study (15 months)

Study Arms (1)

Patients with multiple myeloma

Data to be collected are : * Drug exposition data * Administrative data * Medical data

Other: Administrative dataOther: Medical dataOther: Drug exposition data

Interventions

Administrative dataOTHER

Gender Birthdate Department and town of residence Date of death Affiliation to french Universal Health Coverage

Patients with multiple myeloma
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)

Patients with multiple myeloma
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

Patients with multiple myeloma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multiple myeloma in Midi-Pyrénées

You may qualify if:

  • Beneficiaries or entitled to health insurance or covered by the national system of information of health insurance
  • Identified as multiple myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Routinely Collected Health DataElectronic Health Records

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Health Care SurveysHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsHealth Care Quality, Access, and EvaluationMedical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CarePublic HealthEnvironment and Public Health

Study Officials

  • Lapeyre-Mestre Maryse, PHD

    University Hospital of Toulouse

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 20, 2018

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

August 20, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share