[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-andor-refractory-multiple-myeloma-rrmm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-andor-refractory-multiple-myeloma-rrmm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},915,"ESTIMATED","INTERVENTIONAL",[24],"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)",[27],"Relapsed and\u002For Refractory Multiple Myeloma (RRMM)",[29,30,31,32,33],"BCMA X CD3 Bispecific Monoclonal Antibody","Bispecific combination therapy","Linvoseltamab","Carfilzomib","Proteasome inhibitor","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2026-01-02",{"date":42,"type":21},"2034-08-23",{"name":44,"class":45},"Regeneron Pharmaceuticals","INDUSTRY",20,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100524063","phase-2-18f-fluciclovine-petct-in-multiple-myeloma-100524063","NCT06103838","18F-Fluciclovine PET\u002FCT in Multiple Myeloma","A Phase II Trial Evaluating 18F-Fluciclovine PET\u002FCT in Multiple Myeloma","* INCLUSION CRITERIA:\n* Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \\>= 3 g\u002FdL and\u002For bone marrow plasma cells \\>= 10% and at least one of the following:\n\n  * Anemia: Hemoglobin \\\u003C=10 g\u002FdL, or\n  * Renal Failure: serum creatinine \\>= 2.0 mg\u002FdL, or\n  * Hypercalcemia: Ca \\>= 10.5 mg\u002FdL, or\n  * Lytic bone lesions on X-ray, CT, or PET\u002FCT, or\n  * \\>= 2 focal lesions on spinal MRI, or\n  * \\>= 60% bone marrow plasma cells, or\n  * Involved\u002Fun-involved serum free light chain ration \\>= 100\n* Participants must have measurable disease defined by any one of the following:\n\n  * Monoclonal bone marrow plasma cells \\> 5%\n  * Serum monoclonal protein \\>= 0.2 g\u002Fdl\n  * Urine monoclonal protein \\> 200 mg\u002F24 hr\n  * Serum immunoglobulin free light chain \\> 10 mg\u002FdL AND abnormal kappa\u002Flambda ratio\n  * A measurable lesion on PET\u002FCT or MRI\n* Participants fit criteria for one of the following categories:\n\n  * Newly diagnosed multiple myeloma (NDMM)\n  * Relapsed and\u002For refractory multiple myeloma (RRMM) with at least 1 prior line of therapy\n* Age \\>=18 years.\n* ECOG performance status \\\u003C= 2\n* Negative serum or urine pregnancy test at screening for WOCBP.\n* Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.\n* Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.\n* Uncontrolled intercurrent illness including, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.","120 Years",{"count":56,"type":21},60,[58],"PHASE2","Background:\n\nMultiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier.\n\nObjective:\n\nTo find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose.\n\nEligibility:\n\nAdults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM).\n\nDesign:\n\nParticipants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET\u002FCT scan takes images of their body.\n\nAll participants will have 3 study visits. During each visit they will have:\n\nTwo PET\u002FCT scans. One with 18F-FDG, one with 18F-fluciclovine.\n\nAn optional magnetic resonance imaging scan.\n\nA bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone.\n\nThese tests may be spread over 30 days for each visit.\n\nNDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first.\n\nAll participants will have a third study visit after 5 years or when their disease progresses.",[61,62,27],"Multiple Myeloma","Newly Diagnosed Multiple Myeloma (NDMM)",[64,65,66,67,68,69,61],"RRMM","NDMM","18F-FDG PET\u002FCT","PET\u002FCT","18F-fluciclovine","Imaging","2026-06-27",{"date":35,"type":38},{"date":73,"type":38},"2024-03-25",{"date":75,"type":21},"2032-12-06",{"name":77,"class":78},"National Cancer Institute (NCI)","NIH",1]