Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
Study NCT ID:
NCT07180992
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantitative and Qualitative Monocytes Analysis and Their Impact on CART Cells Reponse in Multiple Myeloma
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Routine blood withdrawal'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': 'day 1'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '3 years'}, {'measure': 'Overall survival', 'timeFrame': '3 years'}, {'measure': 'time to next treatment', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple myeloma', 'Monocytes', 'CART cells', 'Microenvironment'], 'conditions': ['Multiple Myeloma', 'Monocytes', 'CART Cells']}, 'descriptionModule': {'briefSummary': 'Tumoral micro-environment in malignant haematological diseases, notably in multiple myeloma, is active on plasma cells survival and proliferation. Monocytosis and monocytes typing are described in multiple myeloma response as factors on proliferation and cell death evasion. CART cells have improved multiple myeloma care in last 5 years, nethertheless, early relapse occur and we must identify predictor factors of better response. The aim of this study is to analyze basic level and phenotyping of monocytes before and after CART cells infusion and study their impact on multiple myeloma response'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years old Treated for a multiple myeloma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Treated for a multiple myeloma\n* CART cells treatment proposed\n* Affiliated to social security system\n* Agreed to participate to the study'}, 'identificationModule': {'nctId': 'NCT07180992', 'acronym': 'MONOMM', 'briefTitle': 'Quantitative and Qualitative Monocytes Analysis and Their Impact on CART Cells Reponse in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Quantitative and Qualitative Monocytes Analysis and Their Impact on CART Cells Reponse in Multiple Myeloma', 'orgStudyIdInfo': {'id': 'PI2025_843_0130'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lydia Montes, MD', 'role': 'CONTACT', 'email': 'Montes.lydia@chu-amiens.fr', 'phone': '33+322088371'}], 'facility': 'CHRU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Lydia Montes, MD', 'role': 'CONTACT', 'email': 'Montes.lydia@chu-amiens.fr', 'phone': '33+322088371'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}