Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-04 @ 12:48 PM
Study NCT ID:
NCT02627261
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2015-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Myeloma Minimal Residual Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'a gene sequencing technology will be used on bone marrow samples to detect residual disease'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2018-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2015-12-04', 'studyFirstSubmitQcDate': '2015-12-08', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of residual disease', 'timeFrame': 'Residual disease is assessed up to 18 months after inclusion', 'description': 'study the sensitivity of the method of quantification of circulating tumor cells compared to 2 others methods of detection'}], 'secondaryOutcomes': [{'measure': 'kinetic of variation of the residual tumor cells detected by flow cytometry method', 'timeFrame': '18 months', 'description': '% positive cells in bone marrow sample'}, {'measure': 'kinetic of variation of the residual tumor cells detected by new generation sequencing method', 'timeFrame': '18 months', 'description': '% positive in bone marrow sample'}, {'measure': 'kinetic of variation of the circulating tumor cells', 'timeFrame': '18 months', 'description': 'number of cells / mL of blood'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['residual disease'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will focus on adult patients with multiple myeloma and who will receive a treatment with high-dose melphalan and autologous bone marrow transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years\n* previously undiagnosed myeloma\n* eligible for high dose therapy and bone marrow transplantation\n* signed consent\n\nExclusion Criteria:\n\n* ongoing therapy for another neoplasia\n* Patients with other hematologic malignancies,\n* patients deprived of liberty for administrative or judicial reasons\n* previously treated for myeloma'}, 'identificationModule': {'nctId': 'NCT02627261', 'acronym': 'MMRD', 'briefTitle': 'Multiple Myeloma Minimal Residual Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma', 'orgStudyIdInfo': {'id': '69HCL15_0316'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with multiple myeloma', 'description': 'blood samples and bone marrow aspirates will be collected in patients at different time point', 'interventionNames': ['Biological: blood samples and bone marrow aspirates will be collected']}], 'interventions': [{'name': 'blood samples and bone marrow aspirates will be collected', 'type': 'BIOLOGICAL', 'description': 'Serial analysis will be performed at different time point in order to evaluate the presence or absence of residual disease after different treatment steps (before treatment, after induction, after intensification, after consolidation)', 'armGroupLabels': ['patients with multiple myeloma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Hôtel-Dieu de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '69495', 'city': 'Pierre Bénité', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}