Myeloma Treatment in Real Life

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638232
• Other study ID #: 14 7439 07
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)