Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-27 @ 5:24 AM
Study NCT ID:
NCT04561492
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of 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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-05-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis or at relapse.', 'timeFrame': '1 Month', 'description': 'Sensitivity will be assessed by patient and lesion analysis by defining:\n\n* True positive (TP):\n\n * lesion positive with \\[68Ga\\]Ga-PentixaFor-PET and positive by FDG-PET\n * or lesion positive with \\[68Ga\\]Ga-PentixaFor-PET, negative on FDG-PET but confirmed by another CT scan/ MRI or histology, or confirmed by follow-up (until therapeutic evaluation).\n* False negative (FN): - lesion negative with \\[68Ga\\]Ga-PentixaFor-PET and positive by FDG-PET and confirmed by CT or MRI or histology, or confirmed by follow-up.'}], 'secondaryOutcomes': [{'measure': 'To determine at the time of initial diagnosis or at relapse, the specificity, the positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET', 'timeFrame': '1 Month', 'description': 'The specificity (PPV and NPV) of \\[68Ga\\]Ga-PentixaFor-PET at the time of initial diagnosis will be assessed by patient and lesion analysis using the same definitions of TP and FN as for the primary objective.'}, {'measure': 'To determine at the time of initial diagnosis or at relapse, the prognostic impact of FDG PET and of [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique', 'timeFrame': '1 Month', 'description': 'The prognostic impact of PET-FDG and \\[68Ga\\]Ga-PentixaFor-PET based on the number of lesions detected and their intensity of uptake by each imaging technique will be evaluated by assessing the impact of these data on the PFS and OS. PFS is defined as the time from the start of treatment to relapse or progression. OS is defined as the time from the start of first treatment to death.'}, {'measure': 'To determine at the time of initial diagnosis or at relapse, the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET', 'timeFrame': '1 Month', 'description': 'Investigators will consider as discordant a lesion positive by FDG PET but negative by \\[68Ga\\]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by \\[68Ga\\]Ga-PentixaFor-PET'}, {'measure': 'To determine at the time of initial diagnosis or at relapse, the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET', 'timeFrame': '1 Month', 'description': 'Investigators will consider as discordant a lesion positive by FDG PET but negative by \\[68Ga\\]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by \\[68Ga\\]Ga-PentixaFor-PET'}, {'measure': 'To determine at the initial diagnosis or relapse, the correlation between PET-FDG and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV and the cytogenetic data evaluated on the myelogram (particularly the measurement of the expression of the gene coding', 'timeFrame': '1 Month', 'description': '68Ga\\]Ga -PentixaFor and FDG uptakes assessed by SUV and the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases).'}, {'measure': 'To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET', 'timeFrame': '1 Month', 'description': 'Tolerance of \\[68Ga\\]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after \\[68Ga\\]Ga-PentixaFor injection. Clinical data (heart rate, respiratory rate and blood pressure) will be collected prior \\[68Ga\\]Ga -PentixaFor injection before acquisition (at 60 min)'}, {'measure': 'To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET', 'timeFrame': '1 Month', 'description': 'Tolerance of \\[68Ga\\]Ga-PentixaFor will be assessed by clinical monitoring of the patientat the end of acquisition (at approximately 80 min).'}, {'measure': 'To determine at the time of therapeutic evaluation the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET and if available their link with histology.', 'timeFrame': '100 Day or 6 Month', 'description': 'Investigators will consider as discordant a lesion positive by FDG PET but negative by \\[68Ga\\]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by \\[68Ga\\]Ga-PentixaFor-PET'}, {'measure': 'To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.', 'timeFrame': '100 Day and 6 Month', 'description': 'The prognostic impact of \\[68Ga\\]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalisation of images on PFS and OS.'}, {'measure': 'To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.', 'timeFrame': 'Every 6 months after the end of treatment', 'description': 'The prognostic impact of \\[68Ga\\]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalisation of images on PFS and OS.'}, {'measure': 'To determine at the time of therapeutic evaluation the link between PET-FDG, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by flow cytometry', 'timeFrame': '100 Day or 6 Month', 'description': 'PET-FDG, \\[68Ga\\]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by flow cytometry (positive/negative).'}, {'measure': 'To determine at the time of therapeutic evaluation the tolerance of [68Ga]Ga-PentixaFor-PET', 'timeFrame': '100 Day or 6 Month', 'description': 'Tolerance of \\[68Ga\\]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after \\[68Ga\\]Ga -PentixaFor injection. Clinical data (heart rate, respiratory rate and blood pressure) will be collected prior \\[68Ga\\]Ga-PentixaFor injection before acquisition (at 60 min) and at the end of acquisition (at approximately 80 min).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to confirm the relevance of PET using \\[68Ga\\]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and \\[68Ga\\]Ga -PentixaFor/FDG discordances explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment\n* Written and signed informed consent (obtained on the screening day at the latest and before any investigation)\n* ECOG (Eastern Cooperative Oncology Group) \\< 2\n* Patient affiliated to or beneficiary of the National Health Service\n\nExclusion Criteria:\n\n* HIV positive, active Hepatitis B or C\n* Childbearing or child breast feeding women\n* Women or men without effective contraceptive barrier if needed\n* eGFR \\< 50 ml/min by MDRD or CKDEPI\n* Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Known active infection\n* Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus\n* Patient under guardianship or trusteeship\n* Patient under judicial protection'}, 'identificationModule': {'nctId': 'NCT04561492', 'acronym': 'PentiMyelo', 'briefTitle': 'Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Exploratory Study Evaluating the Relevance of [68Ga]Ga -PentixaFor for Initial Staging and Therapeutic Evaluation of Symptomatic Multiple Myeloma Patients in First Line Treatment or in Relapse', 'orgStudyIdInfo': {'id': 'RC19_0289'}, 'secondaryIdInfos': [{'id': '2024-516752-18-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[68Ga]Ga-PentixaFor', 'interventionNames': ['Drug: [68Ga]Ga-PentixaFor']}], 'interventions': [{'name': '[68Ga]Ga-PentixaFor', 'type': 'DRUG', 'description': 'Tomography by emission of positons (PET) with theradiopharmaceutic \\[68Ga\\]Ga-PentixaFor', 'armGroupLabels': ['[68Ga]Ga-PentixaFor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles Mesguich', 'role': 'CONTACT', 'email': 'charles.mesguich@chu-bordeaux.fr'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien Huglo', 'role': 'CONTACT', 'email': 'Damien.HUGLO@chu-lille.fr'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas Jacquet-Francillon', 'role': 'CONTACT', 'email': 'nicolas.jacquet-francillon@chu-lyon.fr'}], 'facility': 'HCL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline Bodet-Milin, MD, PhD', 'role': 'CONTACT', 'email': 'caroline.milin@chu-nantes.fr'}, {'name': 'Caroline Bodet Milin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nantes UH', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Françoise Montravers', 'role': 'CONTACT', 'email': 'francoise.montravers@aphp.fr'}], 'facility': 'APHP - Site Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Caroline Bodet Milin, MD, PhD', 'role': 'CONTACT', 'email': 'caroline.milin@chu-nantes.fr', 'phone': '0240084143', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}