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Completed

NCT Number: NCT03638232

Myeloma Treatment in Real Life

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administrative data

Other

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

Medical data

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

Other

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

Primary outcomes

  1. Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance

    Time frame: Through the end of study (15 months)

Secondary outcomes

  1. Description deliverance scheme of treatment used in multiple myeloma as assessed by data collected in french national system of information of health insurance

    Time frame: Through the end of study (15 months)

  2. Evaluation of respect of official recommendation related to observance in multiple myeloma treatment as assessed by expression of Medication Possession Ratio (MPR)

    Time frame: 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

  3. Description of care consumption in multiple myeloma as assessed by data collected in french national system of information of health insurance

    Time frame: Through the end of study (15 months)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2018
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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