NCT07564219 BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
| NCT ID | NCT07564219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Multiple Myeloma (MM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2026-01-30 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Joseph Tintelnot, MD
PRINCIPAL INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Frequently Asked Questions
Who can join the NCT07564219 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma (MM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07564219 currently recruiting?
Yes, NCT07564219 is actively recruiting participants. Contact the research team at j.weller@uke.de for enrollment information.
Where is the NCT07564219 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT07564219 clinical trial?
NCT07564219 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Joseph Tintelnot, MD at Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 45 participants.