BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic diet, Ketogenic Drinks.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma (MM), CAR T Cells, Bispecific Antibodies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. 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 - Behavioral Ketogenic Drinks
Ketone Performance, DeltaG
Primary outcome measures
- Safety and Tolerability [Time frame: Day 0 to 28 of the intervention]
- CAR-T-Cell Expansion [Time frame: Day 7 after infusion]
- Effector Cytokines [Time frame: Day 1 or 3 after bispecfiic antibody treatment]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Medical Center Hamburg-Eppendorf — Hamburg
Identifiers
NCT: NCT07564219 · 2025-101551-BO