Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT04721002
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2021-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bone marrow aspirate and peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 514}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 't(11;14) status (positive or negative) of the earliest multiple myeloma (MM) sample collected at initial diagnosis or across lines of therapies, by FISH analysis of bone marrow plasma cells is evaluated.'}, {'measure': 'Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 'BCL2 status (BCL2 high or not) of the earliest MM sample collected, either at initial diagnosis or across lines of therapies, by qPCR analysis of bone marrow plasma cells is evaluated.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Stability of t(11;14) Status', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 'Stability of t(11;14) status across intra-patient longitudinal bone marrow (BM) samples (changed vs not changed) collected at initial diagnosis and across lines of therapies.'}, {'measure': 'Percentage of Participants Achieving Stability of BCL2 Status', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 'Stability of BCL2 status across intra-patient longitudinal BM samples (changed vs not changed) collected at initial diagnosis and across lines of therapies.'}, {'measure': 'Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 't(11;14) status (positive or negative) at initial diagnosis and across lines of therapy as determined by BM biopsy.'}, {'measure': 'Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 'BCL2 status (BCL2high or BCL2low) at initial diagnosis and across lines of therapy as determined by BM biopsy.'}, {'measure': 'Percentage of Participants With t(11;14) Status of MM Samples', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 't(11;14) status (positive or negative) of MM samples at different disease stages as determined by BM biopsy.'}, {'measure': 'Percentage of Participants With BCL2 Status of MM Samples', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 'BCL2 status (BCL2high or BCL2low) of MM samples at different disease stages as determined by BM biopsy.'}, {'measure': 'Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 't(11;14) status (positive or negative) of MM samples at different treatment lines stages as determined by BM biopsy.'}, {'measure': 'Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 'BCL2 status (BCL2high or BCL2low) status of MM samples at different treatment lines stages as determined by BM biopsy.'}, {'measure': 'Percentage of Participants With t(1;14) Status and BCL2 Status', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 't(11;14) and BCL2 status (Positive and BCL2high, Negative and BCL2high, Positive and BCL2low, Negative and BCL2low) of the earliest MM samples collected, at initial diagnosis or across lines of therapies, by FISH and qPCR analyses of bone marrow plasma cells, respectively.'}, {'measure': 'Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 'FISH fusion (F) categories (1F, 2F, \\>=3F) among t(11;14) positive samples as determined by BM biopsy.'}, {'measure': 'Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy', 'timeFrame': 'Up to approximately 2.5 months following last subject last visit', 'description': 'FISH fusion (F) categories (1F, 2F, \\>=3F) among t(11;14) positive samples across lines of therapies as determined by BM biopsy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple myeloma (MM)', 'Relapsed/Refractory (R/R) Multiple myeloma (MM)', 't(11', '14)', 'BCL2'], 'conditions': ['Multiple Myeloma (MM)']}, 'referencesModule': {'references': [{'pmid': '40829119', 'type': 'DERIVED', 'citation': 'Spencer A, Gavriatopoulou M, Coriu D, Lysen A, Gutierrez NC, Escalante F, Eugenia Fantl DB, Hajek R, Seguro F, Kaur G, Bittencourt R, Kinda SB, Chu MP, Safah H, Martinez-Lopez J, de Queiroz Crusoe E, Cordeiro de Farias DL, Offidani M, Askari E, Sevindik OG, Maisnar V, Teng CL, Hughes O, Taylor R, Lehn K, Feng D, Thiebaut-Millot R, Li X, Murray L, Jung P, Rossi EL, Kongpachith S, Nichol A, Ross JA, Hader C. Prospective real-world evaluation of t(11;14) prevalence and disease biology in multiple myeloma: MEDICI study analysis. Blood Adv. 2025 Nov 25;9(22):5814-5827. doi: 10.1182/bloodadvances.2025017214.'}]}, 'descriptionModule': {'briefSummary': 'Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM.\n\nApproximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries.\n\nParticipants will receive standard of care while participating in this study. No drug will be administered as a part of this study.\n\nParticipants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with confirmed newly diagnosed or relapsed/refractory multiple myeloma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Confirmed newly diagnosed or relapsed/refractory (R/R) Multiple myeloma (MM) who have signed informed consent for the use of their biological material for research purposes.\n\nExclusion Criteria:\n\n\\- Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.'}, 'identificationModule': {'nctId': 'NCT04721002', 'acronym': 'MEDICI', 'briefTitle': 'Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types', 'orgStudyIdInfo': {'id': 'H20-126'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants With Multiple Myeloma', 'description': 'Participants with newly diagnosed and relapsed/refractory multiple myeloma will receive standard of care. Bone marrow and blood samples will be collected.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane School of Medicine /ID# 223864', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '75390-7208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center /ID# 223865', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '1199', 'city': 'Ciudad Autonoma Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires /ID# 224153'}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Health /ID# 224386', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '41253-190', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital São Rafael /ID# 224307', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre /ID# 224274', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '04537-080', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinica Sao Germano /ID# 224239', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05652-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '22793-080', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto COI de Educacao e Pesquisa /ID# 224245', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01323-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute /ID# 224172', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '10000', 'city': 'Zagreb', 'state': 'City of Zagreb', 'country': 'Croatia', 'facility': 'Klinicki bolnicki centar Zagreb /ID# 226969', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Hradec Kralove /ID# 224089', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '708 52', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Ostrava /ID# 224090', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '59037', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'CHRU Lille - Hopital Claude Huriez /ID# 228919', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'CHU de Nantes, Hotel Dieu -HME /ID# 223702', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hopital Necker /ID# 228062', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '10715', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis am Volkspark /ID# 224763', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '22763', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik Altona /ID# 224761', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '11528', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Alexandra General Hospital /ID# 224828', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': 'D09 XR63', 'city': 'Beaumont', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital /ID# 225514', 'geoPoint': {'lat': 53.38721, 'lon': -6.22713}}, {'zip': '91120', 'city': 'Jerusalem', 'state': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center-Hebrew University /ID# 224884', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '60126', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda /ID# 224608', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht Universitair Medisch Centrum /ID# 224694', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '0450', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Rikshospitalet OUS HF /ID# 227288', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '60-569', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 227038', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-776', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Instytut Hematologii i Transfuzjologii /ID# 227039', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '022328', 'city': 'Bucharest', 'state': 'București', 'country': 'Romania', 'facility': 'Institutul Clinic Fundeni /ID# 224574', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '22384', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Princess Noorah Oncology Center /ID# 224968', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Univ Medical Ctr Ljubljana /ID# 225408', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Germans Trias i Pujol /ID# 229281', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona /ID# 224804', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '24071', 'city': 'León', 'country': 'Spain', 'facility': 'Hospital de Leon /ID# 229191', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundacion Jimenez Diaz /ID# 229524', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre /ID# 225617', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37711', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca /ID# 224803', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital /ID# 227084', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '34214', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bagcilar Medipol Mega Universite Hastanesi /ID# 225515', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}