Myeloma Treatment in Real Life

Toulouse University Hospital

Status: Completed

Conditions: Multiple Myeloma

Treatments: Other: Administrative data; Other: Medical data; Other: Drug exposition data

Study type: Observational

Funder types: Other

Identifiers

NCT03638232

14 7439 07

Details and patient eligibility

About

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.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

236 participants in 1 patient group

Patients with multiple myeloma

Description:

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

Treatment:

Other: Drug exposition data

Other: Medical data

Other: Administrative data