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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":98,"description":25,"timeFrame":12},"Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20",{"measure":100,"description":101,"timeFrame":12},"Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)","Part 2 The EQ-5D-5L is a generic questionnaire that measures HRQoL across 5 dimensions of health (mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression) 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":103,"description":104,"timeFrame":12},"Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5","Part 2 FACIT Item GP5 is a recommended item by the Federal Drug Administration (FDA) in its recent draft guidance for cancer trials to assess patient-reported overall impact of treatment toxicity.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)",null,{"allocation":107,"interventionModel":108,"interventionModelDescription":105,"primaryPurpose":109,"observationalModel":105,"timePerspective":105,"maskingInfo":110},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":111,"maskingDescription":105,"whoMasked":105},"NONE",[113,118,122,125,128],{"label":114,"type":115,"description":105,"interventionNames":116},"Part 1: Arm A","EXPERIMENTAL",[117],"Drug: Linvoseltamab",{"label":119,"type":115,"description":105,"interventionNames":120},"Part 1: Arm B",[117,121],"Drug: Carfilzomib",{"label":123,"type":115,"description":105,"interventionNames":124},"Part 2: Arm A",[117],{"label":126,"type":115,"description":105,"interventionNames":127},"Part 2: Arm B",[117,121],{"label":129,"type":115,"description":105,"interventionNames":130},"Part 2: Arm C",[121,131,132,133,134],"Drug: 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York","10021",{"type":191,"coordinates":201},[202,203],-74.00597,40.71427,{"lat":203,"lon":202},{"facility":206,"status":184,"city":207,"state":208,"zip":209,"country":188,"countryCode":189,"cosmosGeoPoint":210,"geoPoint":214,"contacts":105},"OhioHealth","Columbus","Ohio","43214",{"type":191,"coordinates":211},[212,213],-82.99879,39.96118,{"lat":213,"lon":212},{"facility":216,"status":184,"city":217,"state":218,"zip":219,"country":188,"countryCode":189,"cosmosGeoPoint":220,"geoPoint":224,"contacts":105},"Baylor University Medical Center","Dallas","Texas","75246",{"type":191,"coordinates":221},[222,223],-96.80667,32.78306,{"lat":223,"lon":222},{"facility":226,"status":184,"city":227,"state":218,"zip":228,"country":188,"countryCode":189,"cosmosGeoPoint":229,"geoPoint":233,"contacts":105},"University of Texas Health Science Center, 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Hematology","Plymouth","Devon","PL6 8DH",{"type":191,"coordinates":511},[512,513],-4.14305,50.37153,{"lat":513,"lon":512},{"facility":516,"status":184,"city":517,"state":518,"zip":519,"country":488,"countryCode":489,"cosmosGeoPoint":520,"geoPoint":524,"contacts":105},"Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust","Norwich","Norfolk","NR4 7UY",{"type":191,"coordinates":521},[522,523],1.29834,52.62783,{"lat":523,"lon":522},{"facility":526,"status":184,"city":527,"state":528,"zip":529,"country":488,"countryCode":489,"cosmosGeoPoint":530,"geoPoint":534,"contacts":105},"University Hospitals Birmingham NHS Trust, Center for Clinical","Birmingham","West Midlands","B15 2GW",{"type":191,"coordinates":531},[532,533],-1.89983,52.48142,{"lat":533,"lon":532},{"facility":536,"status":184,"city":537,"state":105,"zip":538,"country":488,"countryCode":489,"cosmosGeoPoint":539,"geoPoint":543,"contacts":105},"Ninewells Hospital and Medical School","Dundee","DD1 9SY",{"type":191,"coordinates":540},[541,542],-2.97489,56.46913,{"lat":542,"lon":541},{"type":545,"investigatorFullName":105,"investigatorTitle":105,"investigatorAffiliation":105,"oldNameTitle":105,"oldOrganization":105},"SPONSOR","100610067","phase-3-a-study-to-compare-linvoseltamab-monotherapy-and-linvoseltamab--carfilzomib-combination-therapy-with-standard-of-care-combination-regimens-in-adult-participants-with-relapsedrefractory-multiple-myeloma-rrmm-100610067",false,"NCT07222761","A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed\u002FRefractory Multiple Myeloma (RRMM)","An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed\u002FRefractory Multiple Myeloma","LINKER-MM5","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\u002Fexclusion criteria apply","ALL","18 Years",{"count":557,"type":558},915,"ESTIMATED","INTERVENTIONAL",[561],"PHASE3","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)",[564],"Relapsed and\u002For Refractory Multiple Myeloma (RRMM)",[566,567,138,145,568],"BCMA X CD3 Bispecific Monoclonal Antibody","Bispecific combination therapy","Proteasome inhibitor","2026-10-07",{"date":571,"type":572},"2026-10-08","ACTUAL",{"date":574,"type":572},"2026-01-02",{"date":576,"type":558},"2034-08-23",{"name":5,"class":6},39]