Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-02 @ 11:07 PM
Study NCT ID:
NCT06285318
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730985', 'term': 'talquetamab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials', 'timeFrame': 'Baseline (Day 1)', 'description': "Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported."}, {'measure': 'Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials', 'timeFrame': 'Up to 40 months', 'description': 'ORR is defined as the percentage of patients who have a PR or better as assessed by investigator per International Myeloma Working Group (IMWG) response criteria.'}, {'measure': 'Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials', 'timeFrame': 'Up to 40 months', 'description': 'Time to first response is defined as the time between date of first dose of teclistamab/talquetamab and the date when patient has achieved first response, as assessed by investigator per IMWG response criteria.'}, {'measure': 'Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials', 'timeFrame': 'Up to 40 months', 'description': 'Time to best response is defined as the time between date of first dose of teclistamab/talquetamab and the date of the best response, as assessed by investigator per IMWG response criteria.'}, {'measure': 'Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials', 'timeFrame': 'Up to 40 months', 'description': 'DOR will be calculated among participants (with a PR or better response) from the date of the first response (PR or better) to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria.'}, {'measure': 'Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials', 'timeFrame': 'Up to 40 months', 'description': 'Number of participants with MRD negative rate will be assessed.'}, {'measure': 'Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials', 'timeFrame': "From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)", 'description': "OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death."}, {'measure': 'Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials', 'timeFrame': 'Up to 40 months', 'description': 'PFS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria, or death due to any cause, whichever occurs first.'}, {'measure': 'Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials', 'timeFrame': 'Up to 40 months', 'description': 'TTNT is defined as the time from the date of first dose of teclistamab/talquetamab to the start of the next line of antimyeloma treatment.'}, {'measure': 'Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials', 'timeFrame': 'Baseline (Day 1) up to end of treatment (up to 40 months)', 'description': 'Incidence and severity of adverse events (AEs) including immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS) and other AEs as well as medications used for prophylaxis and management of adverse events will be reported.'}], 'secondaryOutcomes': [{'measure': 'Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials', 'timeFrame': 'Baseline (Day 1) up to end of treatment (up to 40 months)', 'description': 'Treatment patterns including healthcare setting and treatment schedules will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Multiple Myeloma (RRMM)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population include patients who have initiated the treatment with T-cell redirectors outside of a clinical trial setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a documented diagnosis of multiple myeloma\n* Received the first dose of teclistamab on or before 31 December 2022, regardless of the duration of teclistamab treatment (REALiTEC cohort 1) OR Received the first dose of teclistamab from 01 January 2023 to 31 December 2024, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 2) OR Received the first dose of teclistamab from 01 January 2025 to 31 December 2025, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 3) OR Received the first dose of talquetamab on or before 31 December 2023, regardless of the duration of talquetamab treatment (REALiTAL cohort). Participants who received both teclistamab \\& talquetamab can be included in both REALiTEC and REALiTAL cohorts\n* Received at least one dose of teclistamab/talquetamab\n* Provision of a patient-signed informed consent form (ICF), or an ICF waiver for deceased patients as applicable based on country/site-specific requirements\n\nExclusion Criteria:\n\n* To be excluded from REALiTEC cohorts if received teclistamab as part of an interventional clinical trial\n* To be excluded from REALiTAL cohort if received talquetamab as part of an interventional clinical trial\n* Participants who have received teclistamab as part of a Janssen pre-approval access program are excluded from the REALiTEC Cohort 2 and REALiTEC Cohort 3'}, 'identificationModule': {'nctId': 'NCT06285318', 'acronym': 'REALiTEC/TAL', 'briefTitle': 'A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag Ltd.'}, 'officialTitle': 'A Retrospective, Multicountry Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Treated With T-cell Redirectors Outside of Clinical Trials', 'orgStudyIdInfo': {'id': '64007957MMY4004'}, 'secondaryIdInfos': [{'id': '64007957MMY4004', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 1', 'description': 'Participants with RRMM who received at least one dose of teclistamab outside of clinical trials on or before 31 December 2022 will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab.', 'interventionNames': ['Other: Teclistamab']}, {'label': 'Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 2', 'description': 'Participants with RRMM who received at least one dose of teclistamab outside of clinical trials from 01 January 2023 to 31 December 2024, inclusive will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab.', 'interventionNames': ['Other: Teclistamab']}, {'label': 'Participants with RRMM: Teclistamab Cohort 3', 'description': 'Participants with RRMM who received at least one dose of teclistamab outside of clinical trials from 01 January 2025 to 31 December 2025, inclusive will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab.', 'interventionNames': ['Other: Teclistamab']}, {'label': 'Participants with RRMM: Talquetamab Cohort', 'description': 'Participants with RRMM who received at least one dose of talquetamab outside of clinical trials on or before 31 December 2023 will be enrolled in the study. The data available from the medical records of each enrolled participant will be collected to describe the use of talquetamab.', 'interventionNames': ['Other: Talquetamab']}], 'interventions': [{'name': 'Teclistamab', 'type': 'OTHER', 'otherNames': ['TECVAYLI'], 'description': 'No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.', 'armGroupLabels': ['Participants with RRMM: Teclistamab Cohort 3', 'Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 1', 'Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 2']}, {'name': 'Talquetamab', 'type': 'OTHER', 'otherNames': ['TALVEY'], 'description': 'No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.', 'armGroupLabels': ['Participants with RRMM: Talquetamab Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9100', 'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Aalborg Sygehus Syd', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Aarhus Universitetshospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2100', 'city': 'Copenhagen', 'status': 'COMPLETED', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '7100', 'city': 'Vejle', 'status': 'COMPLETED', 'country': 'Denmark', 'facility': 'Sygehus Lillebælt, Vejle', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Albert Calmette - CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13009', 'city': 'Marseille', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de Nantes hotel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75475', 'city': 'Paris', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Hopital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31100', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Universitaire du Cancer Toulouse Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHRU de Nancy - Hopitaux de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '09116', 'city': 'Chemnitz', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinikum Chemnitz gGmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '01307', 'city': 'Dresden', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Universitatsklinikum Carl Gustav Carus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'University Hospital Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30459', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinikum Region Hannover Klinikum Siloah', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Uniklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '90419', 'city': 'Nuremberg', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Klinikum Nurnberg Nord', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '97080', 'city': 'Würzburg', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg Med. 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