BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ketogenic diet
BehavioralInduction 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
Ketogenic Drinks
BehavioralKetone Performance, DeltaG
Treatment groups
45 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Arm A 1Experimental treatment 1 intervention
Group B: Arm A2Experimental treatment 1 intervention
Group C: A3Experimental treatment 1 intervention
Group D: A4No intervention 0 interventions
Group E: B1Experimental treatment 1 intervention
Group F: B2Experimental treatment 1 intervention
Group G: B3Experimental treatment 1 intervention
Group H: B4Experimental treatment 1 intervention
Group I: B 5No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Safety and Tolerability
No occurrence of Cytokine Release Syndrome (CRS) Grade ≥3 or neurotoxicity (ICANS) Grade ≥3, AND completion of the full 28-day intervention in ≥80% of participants per arm (≥4/5 per arm).
Time frame
Day 0 to 28 of the intervention2
CAR-T-Cell Expansion
Number of CAR-T-Cells per ml of blood
Time frame
Day 7 after infusion3
Effector Cytokines
Protein abundance per ml of blood or cytokines signature of effector cells
Time frame
Day 1 or 3 after bispecfiic antibody treatmentSponsors and contacts
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Source ClinicalTrials.gov