[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"European Myeloma Network B.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":148},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,68,94,122],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100457990","phase-3-phase-3-study-of-teclistamab-in-combination-with-lenalidomide-and-teclistamab-alone-versus-lenalidomide-alone-in-participants-with-newly-diagnosed-multiple-myeloma-as-maintenance-therapy-following-autologous-stem-cell-transplantation-100457990",false,"NCT05243797","Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation","Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4","MajesTEC-4","Inclusion Criteria:\n\n* Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +\u002F- consolidation.\n* Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.\n* Must not be intolerant to the starting dose of lenalidomide.\n* Must not have received any maintenance therapy.\n* Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment\n* Have clinical laboratory values within prespecified range.\n\nExclusion Criteria:\n\n* Received any prior BCMA-directed therapy.\n* Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).\n* Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.\n* Progressed on multiple myeloma therapy at any time prior to screening.\n* Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.\n* Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.","ALL","18 Years",{"count":20,"type":21},1594,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.",[27],"Multiple Myeloma",[29,30],"Maintenance","Teclistamab","RECRUITING","2026-06-03",{"date":34,"type":35},"2026-06-04","ACTUAL",{"date":37,"type":35},"2022-09-08",{"date":39,"type":21},"2032-04",{"name":41,"class":42},"European Myeloma Network B.V.","NETWORK",212,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100566016","phase-2-a-phase-ii-trial-of-teclistamab-in-participants-with-previously-treated-immunoglobulin-light-chain-al-amyloidosis-100566016","NCT06649695","A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis","Inclusion Criteria:\n\n* Histologic diagnosis of AL amyloidosis and typed with immunohistochemistry\u002F immunofluorescence, immunoelectron microscopy, or mass spectrometry. In patients with biopsy-confirmed amyloidosis, ambiguous amyloid typing results, and cardiac involvement alone, a negative pyrophosphate (PYP) or technetium-99m (99mTc) and 3,3-diphosphono-1,2-propanodicarboxylic acid (DPD-Tc99m) bone scan is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.\n* Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry\u002F immunofluorescence\u002F immunoelectron microscopy\u002F mass spectrometry of amyloid deposits must provide clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement. Data from the initial diagnosis are accepted.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2\n* Mayo stage I-IIIA cardiac disease at Screening\n* Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib. Patients must have received at least two cycles of therapy. However, patients who have received high-dose therapy with melphalan as their only therapy are also eligible.\n* Measurable hematologic disease: a dFLC \\>20 mg\u002FL with an abnormal κ\u002Fλ ratio (with Freelite® test kits, The Binding Site) or presence of a monoclonal spike ≥0.5 g\u002FdL.\n* Adequate bone marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:\n* Absolute neutrophils ≥1,000\u002Fmm3,\n* Platelets ≥75,000\u002Fmm3,\n* Hemoglobin ≥8.5 g\u002FdL.\n* Adequate organ function, defined as:\n* Serum creatinine clearance (CKD-EPI formula) ≥20 mL\u002Fmin,\n* Serum SGPT\u002FALT \\\u003C5.0 x Upper Limit of Normal (ULN),\n* Serum total bilirubin \\\u003C2.0 mg\u002FdL or direct bilirubin ≤30% of the total, unless the patient has Gilbert's syndrome, where direct bilirubin should then be \\\u003C2.0 mg\u002FdL,\n* Serum albumin ≥\\\u003C2.5 gr\u002Fdl (medication to correct serum albumin levels is permitted).\n\nExclusion Criteria:\n\n* Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.\n* Isolated soft-tissue involvement.\n* Presence of non-AL amyloidosis.\n* Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).\n* Intolerance to dexamethasone that would prohibit treatment with trial therapy.\n* MM diagnosed as per the International Myeloma Working Group (IMWG) criteria, with the exception of monoclonal gammopathy of unknown significance (MGUS) or smoldering Myeloma, not requiring treatment.\n\nNote: A MM diagnosis with a serum FLC ratio \\>100, as the only myeloma-defining event, does NOT constitute an exclusion.\n\n* All hematologic malignancies, with the exception of low-risk Philadelphia chromosome negative (Ph-) myeloproliferative neoplasms (MPNs) and low-risk myelodysplastic syndromes (MDS), not requiring treatment.\n* Mayo stage IIIB cardiac disease at Screening",{"count":51,"type":21},30,[53],"PHASE2","This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab",[56],"AL Amyloidosis",[58],"teclistamab","2026-04-20",{"date":61,"type":35},"2026-04-21",{"date":63,"type":35},"2025-07-02",{"date":65,"type":21},"2028-09",{"name":41,"class":42},10,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100601210","phase-2-study-for-frail-patients-with-newly-diagnosed-multiple-myeloma-treated-with-daratumumab-with-teclistamab-or-talquetamab-100601210","NCT07107529","Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.","EFfIcacy and Tolerability of FIXed Duration Teclistamab and Talquetamab FOR FRAIL Patients With Newly Diagnosed Multiple Myeloma (2 Cohort Study) - the EMN 37 FITFIX FOR FRAIL Trial","Inclusion Criteria:\n\n1. Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand the purpose of, and procedures required for, the study and is willing to participate in the study\n2. Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria\n3. Measurable disease defined as M-protein in the serum (≥1 g\u002FdL) or serum free light chain assay ≥10 mg\u002FdL \\[≥100 mg\u002FL\\] and abnormal serum immunoglobulin kappa\u002Flambda FLC ratio\n4. Frail according to the Simplified IMWG frailty index\n5. Have clinical laboratory values meeting defined range\n6. Patients of childbearing potential must agree to use adequate\u002Fhighly effective contraception from the time of signing the informed consent form through 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n1. Non-secretory MM or measurable disease by urine or plasmacytoma only\n2. Central nervous system involvement of myeloma\n3. Significant pulmonary dysfunction\n4. Stroke, transient ischemic attack, or seizure within 6 months of eligibility\n5. Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy\n6. HIV and Hepatitis infections\n7. Exclude for any of the following:\n\n   1. Any history of malignancy other than MM which is considered at high risk of recurrence requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity.\n   2. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma.\n8. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility\n9. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI)\n10. Extensive radiotherapy within 14 days or focal radiation only within 7 days of eligibility\n11. Current or active therapy for multiple myeloma or received a cumulative dose corticosteroids equivalent to \\>40 mg dexamethasone within the 14 days prior to C1D1\n12. Received a live attenuated vaccine ≤4 weeks before eligibility. Non-live vaccines or non-replicating authorized for emergency use (eg, COVID-19) are allowed\n13. Received a strong CYP3A4 inducer or use of St. John's wort ≤5 half-lives prior to dosing\n14. Patient had major surgery or significant traumatic injury within 2 weeks prior to eligibility. Kyphoplasty or Vertebroplasty is not considered major surgery\n15. Have received an investigational drug (including investigation vaccines) or used an invasive investigational medical device \\\u003C4 week or 5 PK half-lives, before eligibility or is currently enrolled in an interventional investigational study except if only long-term survival data are collected\n16. Concurrent medical or psychiatric condition or disease (eg, uncontrolled diabetes, alcohol or drug abuse, severe dementia or altered mental status), that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participation in the study\n17. Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg,, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":76,"type":21},150,[53],"This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab.\n\nThe main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2).",[80],"Multiple Myeloma (MM)",[82,83,84,30],"Newly diagnosed multiple myeloma (NDMM)","Frail patient","Talquetamab","2026-04-10",{"date":87,"type":35},"2026-04-15",{"date":89,"type":35},"2025-12-12",{"date":91,"type":21},"2034-02",{"name":41,"class":42},29,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100587759","phase-3-a-study-to-learn-how-safe-and-how-well-linvoseltamab-works-compared-to-standard-treatment-in-adult-patients-with-multiple-myeloma-who-are-not-eligible-for-transplant-100587759","NCT06932562","A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant","A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients","Inclusion Criteria:\n\n1. Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.\n2. Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.\n3. Participants must have measurable disease as defined in the protocol.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n5. Participants must have clinical laboratory values within a prespecified range.\n\nExclusion Criteria:\n\n1. International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.\n2. Participants who defer transplant due to personal preference.\n3. Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.\n4. Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:\n\n   * focal radiation and\u002For\n   * a short course of corticosteroids as defined in the protocol.\n5. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM\n6. Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1.\n7. Participants who have uncontrolled intercurrent illness.\n8. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.\n9. History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.\n\nNOTE Other protocol defined inclusion\u002Fexclusion criteria apply.",{"count":102,"type":21},1000,[24],"This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).\n\nThe main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.",[27],[80,107,108,109,110,111,112],"Transplant ineligible","Newly diagnosed","Linvoseltamab","BCMA X CD3 bispecific antibody","CD38 antibody","Lenalidomide","2026-03-24",{"date":115,"type":35},"2026-03-25",{"date":117,"type":35},"2025-12-23",{"date":119,"type":21},"2036-12",{"name":41,"class":42},59,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100534359","european-myeloma-network-emn-sample-project-100534359","NCT06237803","European Myeloma Network (EMN) Sample Project","EMN Prospective Sample Collection Project","EMN36","Inclusion Criteria:\n\n* Subjects with MGUS, smouldering Multiple Myeloma (SMM) , MM (Multiple Myeloma) (+\u002F- EMD), plasma cell leukemia (PCL) (+\u002F- EMD)\n* Subjects are ≥ 18 years old.\n* Subjects have provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any project-specific activities or procedures.\n\n  1. Subjects do not have kind of condition that, in the opinion of the Investigators, may compromise the ability of the subjects to give written informed consent and\n  2. subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements.\n\nExclusion Criteria:\n\n* Previous treatment with anti-myeloma therapy (excluding one course of therapy in patients in which urgent therapy is deemed necessary according to physician's discretion, e.g. myeloma-related complications resistant to supportive care).\n* Subjects have had prior unforeseen (serious) adverse reactions to blood donation including, but not limited to fainting, angina, severe bruising, allergic reactions, or any other adverse events.\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the protocol and follow-up schedule.",{"count":131,"type":21},6000,"OBSERVATIONAL","This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples.\n\nThis study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples",[27,135,136,137,138],"Smoldering Multiple Myeloma","Plasma Cell Leukemia","Extramedullary Myeloma","MGUS","2025-12-02",{"date":141,"type":35},"2025-12-03",{"date":143,"type":35},"2022-12-21",{"date":145,"type":21},"2037-12",{"name":41,"class":42},41,""]