Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-29 @ 6:26 PM
Study NCT ID:
NCT07222761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C524865', 'term': 'carfilzomib'}, {'id': 'C556306', 'term': 'daratumumab'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C467566', 'term': 'pomalidomide'}, {'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 915}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2034-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2025-10-28', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-06-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 5 years', 'description': 'Part 1'}, {'measure': 'Severity of TEAEs', 'timeFrame': 'Up to 5 years', 'description': 'Part 1'}, {'measure': 'Occurrence of Adverse Events of Special Interest (AESI)', 'timeFrame': 'Up to 5 years', 'description': 'Part 1'}, {'measure': 'Severity of AESIs', 'timeFrame': 'Up to 5 years', 'description': 'Part 1'}, {'measure': 'Occurrence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 5 years', 'description': 'Part 1'}, {'measure': 'Severity of SAEs', 'timeFrame': 'Up to 5 years', 'description': 'Part 1'}, {'measure': 'Minimal Residual Disease (MRD)-negative Complete Response (CR)', 'timeFrame': 'At 12 months', 'description': 'Part 2'}, {'measure': 'Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}], 'secondaryOutcomes': [{'measure': 'Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)', 'timeFrame': 'Up to 28 days', 'description': 'Part 1'}, {'measure': 'Timing of grade ≥2 CRS', 'timeFrame': 'Up to 28 days', 'description': 'Part 1'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 7 years', 'description': 'Part 2'}, {'measure': 'Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Achievement of CR or better per IMWG response criteria as determined by BIRC', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Duration Of Response (DOR) as per IMWG response criteria', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Time To Progression (TTP) as per IMWG response criteria', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Time To Next Treatment (TTNT)', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Second PFS', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'MRD-negative CR criteria at any time', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Time to PR IMWG response category', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Time to VGPR IMWG response category', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Time to CR IMWG response category', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Time to stringent Complete Response (sCR) IMWG response category', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Sustained MRD-negative CR', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Duration of MRD-negative CR', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Occurrence of TEAEs', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Severity of TEAEs', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Occurrence of AESIs', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Severity of AESIs', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Occurrence of SAEs', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Severity of SAEs', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Concentrations of linvoseltamab in serum over time', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Incidence of Antidrug Antibodies (ADAs) to linvoseltamab', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Magnitude of ADAs to linvoseltamab', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'Up to 5 years', 'description': 'Part 2 The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported QoL using 1 GHS/QoL scale, 5 functioning scales (physical, role, emotional, cognitive and social) and 9 symptom scales / items (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer.\n\nParticipants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."'}, {'measure': 'Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Change from baseline in Role Functioning (RF), per EORTC QLQ-C30', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Change from baseline in pain, per EORTC QLQ-C30', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Change from baseline in fatigue, per EORTC QLQ-C30', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])', 'timeFrame': 'Up to 5 years', 'description': 'Part 2 EORTC QLQ-MY20 is an accompanying 20-item validated questionnaire that measure quality of life among patients living with MM across 4 scales (disease symptoms, side effect of treatment, body image and future perspective). A high score represents a high level of symptoms or problems.'}, {'measure': 'Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20', 'timeFrame': 'Up to 5 years', 'description': 'Part 2'}, {'measure': 'Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)', 'timeFrame': 'Up to 5 years', 'description': 'Part 2 The EQ-5D-5L is a generic questionnaire that measures HRQoL across 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) across 5 levels (no problems, slight problems, some problems, severe problems and extreme problems) and a VAS of pain (where 0: no pain and 10: worst pain), higher scores indicate higher pain.'}, {'measure': 'Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5', 'timeFrame': 'Up to 5 years', 'description': 'Part 2 FACIT Item GP5 is a recommended item by the Federal Drug Administration (FDA) in its recent draft guidance for cancer trials to assess patient-reported overall impact of treatment toxicity. It uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BCMA X CD3 Bispecific Monoclonal Antibody', 'Bispecific combination therapy', 'Linvoseltamab', 'Carfilzomib', 'Proteasome inhibitor'], 'conditions': ['Relapsed and/or Refractory Multiple Myeloma (RRMM)']}, 'descriptionModule': {'briefSummary': 'This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.\n\nThe aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody\n2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2\n3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy\n\nKey Exclusion Criteria:\n\n1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded\n2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement\n4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder\n\nNOTE: Other protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT07222761', 'acronym': 'LINKER-MM5', 'briefTitle': 'A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'R5458-ONC-2246'}, 'secondaryIdInfos': [{'id': '2024-519504-27-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Arm A', 'interventionNames': ['Drug: Linvoseltamab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Arm B', 'interventionNames': ['Drug: Linvoseltamab', 'Drug: Carfilzomib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Arm A', 'interventionNames': ['Drug: Linvoseltamab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Arm B', 'interventionNames': ['Drug: Linvoseltamab', 'Drug: Carfilzomib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Arm C', 'interventionNames': ['Drug: Carfilzomib', 'Drug: Daratumumab', 'Drug: Dexamethasone', 'Drug: Pomalidomide', 'Drug: Bortezomib']}], 'interventions': [{'name': 'Linvoseltamab', 'type': 'DRUG', 'otherNames': ['REGN5458', 'Lynozyfic™'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Part 1: Arm A', 'Part 1: Arm B', 'Part 2: Arm A', 'Part 2: Arm B']}, {'name': 'Carfilzomib', 'type': 'DRUG', 'otherNames': ['Kyprolis®'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Part 1: Arm B', 'Part 2: Arm B', 'Part 2: Arm C']}, {'name': 'Daratumumab', 'type': 'DRUG', 'otherNames': ['Darzalex Faspro®', 'Darzalex®'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Part 2: Arm C']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Dexahexal®'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Part 2: Arm C']}, {'name': 'Pomalidomide', 'type': 'DRUG', 'otherNames': ['Imnovid®', 'Pomalyst®'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Part 2: Arm C']}, {'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade®'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Part 2: Arm C']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}