Myeloma Treatment in Real Life

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: Administrative data; Other: Medical data; Other: Drug exposition data

• Registration Number: NCT03638232
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2018-08
• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-17
• Last Update Submitted: 2018-08-17
• Study First Posted: 2018-08-20
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with multiple myeloma	Medical data	Data to be collected are : * Drug exposition data * Administrative data * Medical data
Patients with multiple myeloma	Drug exposition data	Data to be collected are : * Drug exposition data * Administrative data * Medical data
Patients with multiple myeloma	Administrative data	Data to be collected are : * Drug exposition data * Administrative data * Medical data

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)	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
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)
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)