[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636325":3},{"organization":4,"armGroups":7,"interventions":47,"overallOfficials":57,"centralContacts":61,"locations":70,"responsibleParty":87,"collaborators":27,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":27,"enrollmentInfo":98,"targetDuration":27,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":73,"whyStopped":27,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Universitätsklinikum Hamburg-Eppendorf","OTHER",[8,14,18,23,28,32,36,40,44],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A 1","EXPERIMENTAL","Bispecific Antibody - Arm A1 - Ketone Monoester Low Dose Ketone Performance, DeltaG: 3 × 37 ml\u002Fday (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink) for 4 weeks, starting Day -1 before bispecific antibody therapy. Drink times: 08:00, 12:00, 16:00.",[13],"Behavioral: Ketogenic Drinks",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm A2","Bispecific Antibody - Arm A2 - Ketone Monoester High Dose Ketone Performance, DeltaG: ≈3 × 68.5 ml\u002Fday (≈3 × 25 g D-BHB; 3 × 72 g DeltaG drink) for 4 weeks, starting Day -1 before bispecific antibody therapy. Maximum dose per GRAS designation. Drink times: 08:00, 12:00, 16:00.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"A3","Bispecific Antibody - Arm A3 - Ketogenic Diet Ketogenic diet per protocol of Hirschberger et al. EMBO Molecular Medicine 2021 for 4 weeks, starting Day -1 before bispecific antibody therapy.",[22],"Behavioral: Ketogenic diet",{"label":24,"type":25,"description":26,"interventionNames":27},"A4","NO_INTERVENTION","Bispecific Antibody - Arm A4 - Control Group No dietary intervention. Standard-of-care bispecific antibody therapy. Translational control samples and clinical control data collected per follow-up schedule.",null,{"label":29,"type":10,"description":30,"interventionNames":31},"B1","CAR-T - Arm B1 - Ketone Monoester Low Dose Ketone Performance, DeltaG: 3 × 37 ml\u002Fday (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink) for 4 weeks, starting Day -1 before CAR-T reinfusion. Drink times: 08:00, 12:00, 16:00.",[13],{"label":33,"type":10,"description":34,"interventionNames":35},"B2","CAR-T - Arm B2 - Ketone Monoester Low Dose (Apheresis + Reinfusion) Ketone Performance, DeltaG: 3 × 37 ml\u002Fday (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink). Phase 1: 1 week around apheresis (Day -6 to Day +1 of apheresis). Phase 2: 4 weeks starting Day -1 before CAR-T reinfusion. Drink times: 08:00, 12:00, 16:00.",[13],{"label":37,"type":10,"description":38,"interventionNames":39},"B3","CAR-T - Arm B3 - Ketone Monoester High Dose (Reinfusion only) Ketone Performance, DeltaG: ≈3 × 68.5 ml\u002Fday (≈3 × 25 g D-BHB; 3 × 72 g DeltaG drink) for 4 weeks, starting Day -1 before CAR-T reinfusion (no apheresis phase). Maximum dose per GRAS. Drink times: 08:00, 12:00, 16:00.",[13],{"label":41,"type":10,"description":42,"interventionNames":43},"B4","CAR-T - Arm B4 - Ketogenic Diet Ketogenic diet per protocol of et al. EMBO Molecular Medicine 2021 for 4 weeks, starting Day -1 before CAR-T reinfusion.",[22],{"label":45,"type":25,"description":46,"interventionNames":27},"B 5","Arm B5 - Control Group No dietary intervention. Standard-of-care CAR-T cell therapy (Ciltacabtagene autoleucel). Translational control samples and clinical control data collected per follow-up schedule.",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":27},"BEHAVIORAL","Ketogenic diet","Induction of a stable ketogenic metabolic state to increase blood BHB levels in order to improve T-cell function through immunometabolic reprogramming.\n\nDuration: 4 weeks (28 days)\n\nMacronutrient distribution:\n\n* Carbohydrates: \\\u003C10% of daily caloric intake (approx. 20-30 g\u002Fday)\n* Fats: 70-75% of daily caloric intake\n* Proteins: 15-20% of daily caloric intake",[19,41],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":27},"Ketogenic Drinks","Ketone Performance, DeltaG",[9,15,29,33,37],[58],{"name":59,"affiliation":5,"role":60},"Joseph Tintelnot, MD","PRINCIPAL_INVESTIGATOR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":27,"email":66},"Jan Weller, MD","CONTACT","0049 40 7410 0","j.weller@uke.de",{"name":68,"role":64,"phone":27,"phoneExt":27,"email":69},"Lisa Leypoldt, MD","l.leypoldt@uke.de",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"University Medical Center Hamburg-Eppendorf","RECRUITING","Hamburg","Free and Hanseatic City of Hamburg","20251","Germany","DE",{"type":80,"coordinates":81},"Point",[82,83],9.99302,53.55073,{"lat":83,"lon":82},[86],{"name":63,"role":64,"phone":27,"phoneExt":27,"email":66},{"type":88,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","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":99,"type":100},45,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106,107,108],"Multiple Myeloma (MM)","CAR T Cells","Bispecific Antibodies",[110,111],"Ketogenic Diet","beta-hydroxybutyrate (BHB)","2026-04-26",{"date":114,"type":115},"2026-05-04","ACTUAL",{"date":117,"type":115},"2026-01-30",{"date":119,"type":100},"2028-12-31",{"name":5,"class":6},1]