Actively Recruiting
BEAM-MM - Beta-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma Evaluation of Ketogenic Diet and Ketone Supplementation During Immunotherapy
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2026-05-04
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Multiple Myeloma patients planned for CAR-T cell therapy with Ciltacabtagene autoleucel or a BCMA-directed bispecific antibody.
- Age 18 years or older at the time of informed consent.
You will not qualify if you...
- Active infection requiring systemic therapy.
- Known history of HIV or Hepatitis infection.
- Significant weight loss greater than 10% within the last 6 weeks.
- ECOG Performance Status of 2 or higher.
- Previous immunoeffector cell therapy (CAR-T or bispecific antibodies).
- Active immunosuppression from other conditions like autoimmune disease or second malignancy.
- Very high tumor burden with high risk for tumor lysis syndrome.
- Women of childbearing potential without reliable exclusion of pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks (28 days)
Participants receive ketogenic diet or ketone supplementation starting one day before immunotherapy to enhance adaptive immunity during treatment for multiple myeloma.
Daily ketone drink intake or adherence to ketogenic diet for 4 weeks
Duration - Up to several weeks after treatment
Participants are monitored for safety, immune response, and treatment effects after the 4-week intervention period.
Follow-up visits as scheduled to assess safety and treatment outcomes
Trial Site Locations
Total: 1 location
1
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20251
Actively Recruiting
Research Team
J
Jan Weller, MD
L
Lisa Leypoldt, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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