Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:16 PM
Study NCT ID:
NCT07482761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Myeloma t(4 ;14) FFPE Samples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'The study plans to collect formalin fixed embedded samples (FFPE) and to cut unstained histopathological slides for immunohistochemistry techniques. No DNA extraction'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Describe the distribution of treatment received by the patients with t(4;14) multiple myeloma', 'timeFrame': 'Baseline', 'description': 'Categorization of treatment (according to treatment class and line of therapy, including proteasome inhibitors, immunomodulatory drugs, anti-CD38 monoclonal antibodies, and other targeted agents). Data are collected by reviewing sample metadata recorded at the time of diagnostic tissue processing.'}], 'primaryOutcomes': [{'measure': 'Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed myeloma disease with (4;14) translocation.', 'timeFrame': 'Baseline', 'description': 'Number of participants who meet both criteria: - confirmation of t(4;14) disease using predefined clinical and histopathological criteria, and - availability of an adequate FFPE tissue block suitable for inclusion. Feasibility will be quantified by reporting the proportion of eligible participants among all patients screened for potential inclusion.'}], 'secondaryOutcomes': [{'measure': 'Evaluate FFPE analytical quality through expression rates of predefined IHC markers (CD138, CD56, MUM1, light chains).', 'timeFrame': 'Baseline', 'description': 'Percentage of cases showing immunoreactivity for selected markers based on standard immunohistochemistry performed during diagnostic work-up. Marker expression is recorded as positive or negative according to predefined laboratory thresholds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma and Malignant Plasma Cell Neoplasms']}, 'descriptionModule': {'briefSummary': 'This observational study aims to evaluate the feasibility of assembling a retrospective cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with 4;14 translocated multiple myeloma, together with their associated clinical and pathological data. The study will determine whether these archived samples are suitable for exploratory biomarker assessment.\n\nNo intervention is performed. All FFPE samples and clinical data originate exclusively from routine diagnostic procedures and will be analyzed retrospectively for research purposes.', 'detailedDescription': 'This retrospective observational study aims to determine the feasibility of assembling a cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with 4;14 translocated multiple myeloma and linking these materials with associated clinical and pathological data. All samples originate from routine diagnostic procedures performed as part of standard clinical care; no prospective interventions or additional tissue collection are involved.\n\nThe study evaluates whether archived FFPE specimens and corresponding clinical information can be systematically identified, retrieved, and abstracted using a predefined standardized workflow. Histopathological review and immunohistochemical markers routinely assessed during diagnostic work-up (CD138, CD56, MUM1, light chains) will be used to confirm the diagnosis and describe tumor features. Feasibility will be defined by the proportion of screened cases for which both adequate FFPE material and sufficient clinical data are available to allow inclusion.\n\nThe purpose of the study is to generate a structured dataset enabling future biomarker research and to assess whether the operational workflow used for case identification, data abstraction, and sample processing can be reliably scaled for larger retrospective cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients diagnosed with t(4;14) myeloma for whom a representative FFPE block from a surgical specimen was obtained as part of routine clinical care within the past 10 years. Only cases with sufficient clinical, pathological, and follow-up data are included. All samples were collected outside the context of research activities.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with histologically confirmed myeloma with a t(4;14) translocation\n* Availability of a representative FFPE block from a surgical specimen.\n* Diagnosis established within the past 10 years.\n* Availability of associated clinical and follow-up data.\n\nExclusion Criteria:\n\n* Bone lesions samples\n* Insufficient or non-representative FFPE material.\n* Missing key diagnostic or clinical data.'}, 'identificationModule': {'nctId': 'NCT07482761', 'acronym': 'MM-t4-14-FFPE', 'briefTitle': 'Multiple Myeloma t(4 ;14) FFPE Samples', 'organization': {'class': 'INDUSTRY', 'fullName': 'BIWAKO'}, 'officialTitle': 'Discovery And Validation Of New Biomarkers In The Context Of Multiple Myeloma With t(4-14) and Relapse', 'orgStudyIdInfo': {'id': 'BWK-P035b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FFPE samples', 'description': 'Samples obtained from patients with multiple myeloma disease and confirmed 4;14 translocation. Tissu samples should be obtained (nos aspirate)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69006', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Marie BREVET', 'role': 'CONTACT', 'email': 'm.brevet@biwako.fr', 'phone': '0628010948'}], 'facility': 'BIWAKO', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Marie BREVET, Pr ; MD. PhD.', 'role': 'CONTACT', 'email': 'm.brevet@biwako.fr', 'phone': '+33628010948'}], 'overallOfficials': [{'name': 'Heba RASHED', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MEDARKCRO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BIWAKO', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}