[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574368":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":20,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hospital Universitario Dr. Jose E. Gonzalez","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Patients receiving 3 cycles of VRd followed by low-dose teclistamab.",[13],"Drug: Low-dose teclistamab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Low-dose teclistamab","NDMM patients will receive VRd 3x cicles followed by low dose teclistamab.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"David Gomez-Almaguer, MD","CONTACT","528186756718","dgomezalmaguer@gmail.com",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Monterrey","Nuevo León","64460","Mexico","MX",{"type":36,"coordinates":37},"Point",[38,39],-100.31721,25.68435,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","David Gomez Almaguer","Chief of the Hematology Service","100574368","phase-2-low-dose-teclistamab-in-newly-diagnosed-multiple-myeloma-patients-100574368",false,"NCT06758375","Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients","Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.","Inclusion Criteria:\n\n* ≥18 years of age.\n* Newly diagnosed multiple myeloma.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.\n* Women of childbearing potential must have a negative serum pregnancy test prior to starting treatment and agree to use a highly effective method of contraception, such as a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomy partner.\n* Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy.\n\nExclusion Criteria:\n\n* History of previous treatment for MM.\n* Active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.\n* Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or AL amyloidosis.\n* Severe active infection secondary to viruses, bacteria or fungi.\n* Pulmonary disease requiring supplemental oxygen.\n* History of allogeneic or autologous hematopoietic cell transplantation.\n* Vaccination with live attenuated virus in the 4 weeks prior to teclistamab administration.\n* Major surgery during the 2 weeks prior to the first dose or absence of complete recovery from surgery.\n* Presence of other concomitant malignancy.\n* Hepatitis B and C virus infection or human immunodeficiency virus (HIV) infection.\n* Cerebrovascular events or seizures in the last 6 months.\n* Congestive heart failure class III-IV according to NYHA (New York Heart Association Stage).\n* Acute myocardial infarction or history of coronary revascularization surgery in the last 6 months.\n* Women of childbearing age: active pregnancy prior to the first administration of treatment.","ALL","18 Years",{"count":57,"type":58},10,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients.",[64],"Multiple Myeloma, Newly Diagnosed",[66,67,68,17],"Multiple myeloma","Teclistamab","Newly diagnosed multiple myeloma","2025-03-19",{"date":71,"type":72},"2025-03-20","ACTUAL",{"date":74,"type":72},"2025-03-03",{"date":76,"type":58},"2026-12-01",{"name":5,"class":6},1]