Myeloma Treatment in Real Life

NCT ID: NCT03638232

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 236 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with multiple myeloma

Data to be collected are :

• Drug exposition data
• Administrative data
• Medical data

Administrative data

Intervention Type: OTHER

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

Medical data

Intervention Type: OTHER

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 data

Intervention Type: OTHER

Speciality of prescribing physician CIP code of drug Name of speciality prescribed Date of deliverance Date of prescription Number of treatment box delivered

Interventions

Administrative data

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

Intervention Type: OTHER

Medical data

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)

Intervention Type: OTHER

Drug exposition data

Speciality of prescribing physician CIP code of drug Name of speciality prescribed Date of deliverance Date of prescription Number of treatment box delivered

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lapeyre-Mestre Maryse, PHD

Role: STUDY_DIRECTOR

University Hospital of Toulouse

Other Identifiers

14 7439 07

Identifier Type: -

Identifier Source: org_study_id