Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT03638232
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2018-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myeloma Treatment in Real Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000085143', 'term': 'Routinely Collected Health Data'}, {'id': 'D057286', 'term': 'Electronic Health Records'}], 'ancestors': [{'id': 'D019538', 'term': 'Health Care Surveys'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-17', 'studyFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance', 'timeFrame': 'Through the end of study (15 months)'}], 'secondaryOutcomes': [{'measure': 'Description deliverance scheme of treatment used in multiple myeloma as assessed by data collected in french national system of information of health insurance', 'timeFrame': 'Through the end of study (15 months)'}, {'measure': 'Evaluation of respect of official recommendation related to observance in multiple myeloma treatment as assessed by expression of Medication Possession Ratio (MPR)', 'timeFrame': 'Through the end of study (15 months)', 'description': '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'}, {'measure': 'Description of care consumption in multiple myeloma as assessed by data collected in french national system of information of health insurance', 'timeFrame': 'Through the end of study (15 months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug consumption', 'Response to treatment', 'Non optimal drug use'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nAs 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with multiple myeloma in Midi-Pyrénées', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Beneficiaries or entitled to health insurance or covered by the national system of information of health insurance\n* Identified as multiple myeloma\n* Incident patient : Subject presenting none of inclusion criteria during the 6 months observation period\n\nExclusion Criteria:\n\n* Non incident patient : Subject presenting at least one of inclusion criteria during the 6 months observation period'}, 'identificationModule': {'nctId': 'NCT03638232', 'briefTitle': 'Myeloma Treatment in Real Life', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Myeloma Treatment in Real Life : Pharmacoepidemiological Approach in Midi-pyrénées', 'orgStudyIdInfo': {'id': '14 7439 07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with multiple myeloma', 'description': 'Data to be collected are :\n\n* Drug exposition data\n* Administrative data\n* Medical data', 'interventionNames': ['Other: Administrative data', 'Other: Medical data', 'Other: Drug exposition data']}], 'interventions': [{'name': 'Administrative data', 'type': 'OTHER', 'description': 'Gender Birthdate Department and town of residence Date of death Affiliation to french Universal Health Coverage', 'armGroupLabels': ['Patients with multiple myeloma']}, {'name': 'Medical data', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Patients with multiple myeloma']}, {'name': 'Drug exposition data', 'type': 'OTHER', 'description': 'Speciality of prescribing physician CIP code of drug Name of speciality prescribed Date of deliverance Date of prescription Number of treatment box delivered', 'armGroupLabels': ['Patients with multiple myeloma']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lapeyre-Mestre Maryse, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}