Condition: Multiple Myeloma (MM) · CAR T Cells · Bispecific Antibodies · Sponsor: Universitätsklinikum Hamburg-Eppendorf
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.
This description comes directly from the study's public registry record.
Jan Weller, MD · 0049 40 7410 0 · j.weller@uke.de
Lisa Leypoldt, MD · l.leypoldt@uke.de
Always discuss trial participation with your own doctor first.
| University Medical Center Hamburg-Eppendorf | Hamburg, Free and Hanseatic City of Hamburg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07564219