[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bispecific-antibodies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bispecific-antibodies":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100636325","beam-mm----hydroxybutyrate-enhanced-adaptive-immunity-in-multiple-myeloma-100636325",false,"NCT07564219","BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma","BEAM-MM","Inclusion Criteria:\n\n* Multiple Myeloma with indication for CAR-T cell therapy with Ciltacabtagene autoleucel (target antigen: BCMA) or a BCMA-directed bispecific antibody (e.g., Teclistamab, Elranatamab, Linvoseltamab).\n* Age ≥18 years on the day the informed consent is signed.\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy.\n* Known history of infection with Human Immunodeficiency Virus (HIV) or Hepatitis.\n* Significant short-term weight loss (\\>10% within the last 6 weeks).\n* ECOG Performance Status ≥2.\n* Prior immunoeffector cell therapy (CAR-T cell therapy or bispecific antibodies).\n* Active immunosuppression due to another condition (e.g., autoimmune disease, second malignancy).\n* Very high tumor burden with high risk for tumor lysis syndrome, as determined by myeloma-specific markers or markedly elevated LDH (per the treating myeloma team).\n* Women of childbearing potential in whom pregnancy cannot be reliably excluded prior to study entry.","ALL","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study investigates whether raising blood levels of beta-hydroxybutyrate (BHB) - a natural molecule produced by the body during fasting or a low-carbohydrate diet - is safe and feasible and can improve the effectiveness of immunotherapy in patients with multiple myeloma, while remaining safe and well-tolerated. Patients will be randomly assigned to one of four intervention groups or a control group. The intervention groups will either follow a ketogenic diet (less than 10% of calories from carbohydrates) or receive oral supplementation with deltaG® Ketone Monoester Performance \\[(R)-3-hydroxybutyl (R)-3-hydroxybutyrate; CAS 1208313-97-6; TdeltaS Global, Inc., Oxford, UK\\], administered orally three times daily at either a low dose (13.5 g per serving, 40.5 g\u002Fday) or a high dose (25 g per serving, 75 g\u002Fday), in accordance with the FDA GRAS-approved dosing range. The control group will receive standard nutritional care. The study includes two parts: Part A enrolls patients receiving bispecific antibody treatment, and Part B enrolls patients receiving CAR-T cell therapy. Both dosing levels are applied in each part.",[26,27,28],"Multiple Myeloma (MM)","CAR T Cells","Bispecific Antibodies",[30,31],"Ketogenic Diet","beta-hydroxybutyrate (BHB)","RECRUITING","2026-04-26",{"date":35,"type":36},"2026-05-04","ACTUAL",{"date":38,"type":36},"2026-01-30",{"date":40,"type":20},"2028-12-31",{"name":42,"class":43},"Universitätsklinikum Hamburg-Eppendorf","OTHER"]