BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
Universitätsklinikum Hamburg-Eppendorf
45 participants
Jan 30, 2026
INTERVENTIONAL
Conditions
Summary
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/day) or a high dose (25 g per serving, 75 g/day), 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.
Eligibility
Inclusion Criteria2
- 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).
- Age ≥18 years on the day the informed consent is signed.
Exclusion Criteria8
- Active infection requiring systemic therapy.
- Known history of infection with Human Immunodeficiency Virus (HIV) or Hepatitis.
- Significant short-term weight loss (>10% within the last 6 weeks).
- ECOG Performance Status ≥2.
- Prior immunoeffector cell therapy (CAR-T cell therapy or bispecific antibodies).
- Active immunosuppression due to another condition (e.g., autoimmune disease, second malignancy).
- 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).
- Women of childbearing potential in whom pregnancy cannot be reliably excluded prior to study entry.
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Interventions
Induction of a stable ketogenic metabolic state to increase blood BHB levels in order to improve T-cell function through immunometabolic reprogramming. Duration: 4 weeks (28 days) Macronutrient distribution: * Carbohydrates: \<10% of daily caloric intake (approx. 20-30 g/day) * Fats: 70-75% of daily caloric intake * Proteins: 15-20% of daily caloric intake
Ketone Performance, DeltaG
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07564219