Multiple Myeloma (MM)BEAM-MMNCT07564219
BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
A study testing Ketogenic diet and Ketogenic Drinks in people with Multiple Myeloma (MM) and CAR T Cells, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), CAR T Cells, Bispecific Antibodies
- What is being tested?
- Ketogenic diet and Ketogenic Drinks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lisa Leypoldt, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
Jan Weller, MD, j.weller@uke.de
About this study
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.
- Conditions
- Multiple Myeloma (MM), CAR T Cells, Bispecific Antibodies
- Being tested
- Ketogenic diet, Ketogenic Drinks
- Keywords
- Ketogenic Diet, beta-hydroxybutyrate (BHB)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietBehavioural
Induction 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 DrinksBehavioural
Ketone Performance, DeltaG
| Study group | Role | What they receive |
|---|---|---|
| Arm A 1 | Experimental | Bispecific Antibody - Arm A1 - Ketone Monoester Low Dose Ketone Performance, DeltaG: 3 × 37 ml/day (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink) for 4 weeks, starting Day -1 before bispecific antibody therapy. Drink times: 08:00, 12:00, 16:00. Receives: Behavioral: Ketogenic Drinks |
| Arm A2 | Experimental | Bispecific Antibody - Arm A2 - Ketone Monoester High Dose Ketone Performance, DeltaG: ≈3 × 68.5 ml/day (≈3 × 25 g D-BHB; 3 × 72 g DeltaG drink) for 4 weeks, starting Day -1 before bispecific antibody therapy. Maximum dose per GRAS designation. Drink times: 08:00, 12:00, 16:00. Receives: Behavioral: Ketogenic Drinks |
| A3 | Experimental | Bispecific Antibody - Arm A3 - Ketogenic Diet Ketogenic diet per protocol of Hirschberger et al. EMBO Molecular Medicine 2021 for 4 weeks, starting Day -1 before bispecific antibody therapy. Receives: Behavioral: Ketogenic diet |
| A4 | No intervention | Bispecific Antibody - Arm A4 - Control Group No dietary intervention. Standard-of-care bispecific antibody therapy. Translational control samples and clinical control data collected per follow-up schedule. |
| B1 | Experimental | CAR-T - Arm B1 - Ketone Monoester Low Dose Ketone Performance, DeltaG: 3 × 37 ml/day (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink) for 4 weeks, starting Day -1 before CAR-T reinfusion. Drink times: 08:00, 12:00, 16:00. Receives: Behavioral: Ketogenic Drinks |
| B2 | Experimental | CAR-T - Arm B2 - Ketone Monoester Low Dose (Apheresis + Reinfusion) Ketone Performance, DeltaG: 3 × 37 ml/day (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink). Phase 1: 1 week around apheresis (Day -6 to Day +1 of apheresis). Phase 2: 4 weeks starting Day -1 before CAR-T reinfusion. Drink times: 08:00, 12:00, 16:00. Receives: Behavioral: Ketogenic Drinks |
| B3 | Experimental | CAR-T - Arm B3 - Ketone Monoester High Dose (Reinfusion only) Ketone Performance, DeltaG: ≈3 × 68.5 ml/day (≈3 × 25 g D-BHB; 3 × 72 g DeltaG drink) for 4 weeks, starting Day -1 before CAR-T reinfusion (no apheresis phase). Maximum dose per GRAS. Drink times: 08:00, 12:00, 16:00. Receives: Behavioral: Ketogenic Drinks |
| B4 | Experimental | CAR-T - Arm B4 - Ketogenic Diet Ketogenic diet per protocol of et al. EMBO Molecular Medicine 2021 for 4 weeks, starting Day -1 before CAR-T reinfusion. Receives: Behavioral: Ketogenic diet |
| B 5 | No intervention | Arm B5 - Control Group No dietary intervention. Standard-of-care CAR-T cell therapy (Ciltacabtagene autoleucel). Translational control samples and clinical control data collected per follow-up schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0 to 28 of the intervention
CAR-T-Cell Expansion
Number of CAR-T-Cells per ml of blood
Measured: Day 7 after infusion
Effector Cytokines
Protein abundance per ml of blood or cytokines signature of effector cells
Measured: Day 1 or 3 after bispecfiic antibody treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start30 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Tintelnot, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564219
- Sponsor's protocol ID
- 2025-101551-BO
- Other IDs
- 2025
- Acronym
- BEAM-MM
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07564219
- Acronym / sponsor ID
- BEAM-MM / 2025-101551-BO
- Conditions
- Multiple Myeloma (MM), CAR T Cells, Bispecific Antibodies
- Keywords
- Ketogenic Diet, beta-hydroxybutyrate (BHB)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm A 1 | Experimental | Behavioral: Ketogenic DrinksBispecific Antibody - Arm A1 - Ketone Monoester Low Dose Ketone Performance, DeltaG: 3 × 37 ml/day (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink) for 4 weeks, starting Day -1 before bispecific antibody therapy. Drink times: 08:00, 12:00, 16:00. |
| Arm A2 | Experimental | Behavioral: Ketogenic DrinksBispecific Antibody - Arm A2 - Ketone Monoester High Dose Ketone Performance, DeltaG: ≈3 × 68.5 ml/day (≈3 × 25 g D-BHB; 3 × 72 g DeltaG drink) for 4 weeks, starting Day -1 before bispecific antibody therapy. Maximum dose per GRAS designation. Drink times: 08:00, 12:00, 16:00. |
| A3 | Experimental | Behavioral: Ketogenic dietBispecific Antibody - Arm A3 - Ketogenic Diet Ketogenic diet per protocol of Hirschberger et al. EMBO Molecular Medicine 2021 for 4 weeks, starting Day -1 before bispecific antibody therapy. |
| A4 | No intervention | –Bispecific Antibody - Arm A4 - Control Group No dietary intervention. Standard-of-care bispecific antibody therapy. Translational control samples and clinical control data collected per follow-up schedule. |
| B1 | Experimental | Behavioral: Ketogenic DrinksCAR-T - Arm B1 - Ketone Monoester Low Dose Ketone Performance, DeltaG: 3 × 37 ml/day (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink) for 4 weeks, starting Day -1 before CAR-T reinfusion. Drink times: 08:00, 12:00, 16:00. |
| B2 | Experimental | Behavioral: Ketogenic DrinksCAR-T - Arm B2 - Ketone Monoester Low Dose (Apheresis + Reinfusion) Ketone Performance, DeltaG: 3 × 37 ml/day (≈3 × 13.5 g D-BHB; 3 × 39 g DeltaG drink). Phase 1: 1 week around apheresis (Day -6 to Day +1 of apheresis). Phase 2: 4 weeks starting Day -1 before CAR-T reinfusion. Drink times: 08:00, 12:00, 16:00. |
| B3 | Experimental | Behavioral: Ketogenic DrinksCAR-T - Arm B3 - Ketone Monoester High Dose (Reinfusion only) Ketone Performance, DeltaG: ≈3 × 68.5 ml/day (≈3 × 25 g D-BHB; 3 × 72 g DeltaG drink) for 4 weeks, starting Day -1 before CAR-T reinfusion (no apheresis phase). Maximum dose per GRAS. Drink times: 08:00, 12:00, 16:00. |
| B4 | Experimental | Behavioral: Ketogenic dietCAR-T - Arm B4 - Ketogenic Diet Ketogenic diet per protocol of et al. EMBO Molecular Medicine 2021 for 4 weeks, starting Day -1 before CAR-T reinfusion. |
| B 5 | No intervention | –Arm B5 - Control Group No dietary intervention. Standard-of-care CAR-T cell therapy (Ciltacabtagene autoleucel). Translational control samples and clinical control data collected per follow-up schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietInduction 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 | Behavioural | A3, B4 |
| Ketogenic DrinksKetone Performance, DeltaG | Behavioural | Arm A 1, Arm A2, B1, B2, B3 |
Primary outcome
Safety and Tolerability
Time frame: Day 0 to 28 of the intervention
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).
CAR-T-Cell Expansion
Time frame: Day 7 after infusion
Number of CAR-T-Cells per ml of blood
Effector Cytokines
Time frame: Day 1 or 3 after bispecfiic antibody treatment
Protein abundance per ml of blood or cytokines signature of effector cells
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Leypoldt, MD contact
Joseph Tintelnot, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet and Ketogenic Drinks in people with Multiple Myeloma (MM) and CAR T Cells, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Weller, MD (0049 40 7410 0, j.weller@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Day 0 to 28 of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.