Study of Beta-Hydroxybutyrate to Support Immunotherapy in Adults with Multiple Myeloma Using CAR-T or Bispecific Antibody Treatments

What this Trial Is About

Researchers are evaluating whether increasing blood levels of beta-hydroxybutyrate BHB, a natural molecule produced during fasting or a low-carbohydrate diet, is safe and feasible and can improve the effectiveness of immunotherapy in patients with multiple myeloma. The study focuses on patients receiving either bispecific antibody treatment or CAR-T cell therapy. It aims to assess safety, tolerability, and immune response improvement while monitoring side effects during the treatment period. Participants are randomly assigned to one of four intervention groups or a control group. Intervention groups either follow a ketogenic diet with less than 10% of calories from carbohydrates or receive oral supplementation with deltaG Ketone Monoester Performance at low or high doses. These interventions last for four weeks, starting the day before immunotherapy begins. The control group receives standard nutritional care alongside their immunotherapy. The study has two parts Part A for bispecific antibody treatment and Part B for CAR-T therapy, with similar dosing applied in each. During the study, participants will be monitored for safety and tolerability from day 0 to 28 of the intervention. Researchers will measure CAR-T cell expansion seven days after infusion and effector cytokine levels one or three days after bispecific antibody treatment. Follow-up includes collecting clinical data and samples for translational research. Participants will have scheduled visits and assessments throughout the treatment and observation periods, with the total duration varying by group and treatment type.

BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma