Myeloma Treatment in Real Life

Myeloma Treatment in Real Life : Pharmacoepidemiological Approach in Midi-pyrénées

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: Administrative data; Other: Medical data; Other: Drug exposition data

• Study Type: Observational
• Enrollment (Actual): 236

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple myeloma in Midi-Pyrénées

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with multiple myeloma; Data to be collected are : Drug exposition data; Administrative data; Medical data

Other: Administrative data; Gender Birthdate Department and town of residence Date of death Affiliation to french Universal Health Coverage; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)	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	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)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Study Director: Lapeyre-Mestre Maryse, PHD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Drug consumption; Response to treatment; Non optimal drug use
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 14 7439 07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO