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

26. april 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Jan Weller, MD
  • Telefonnummer: 0049 40 7410 0
  • E-mail: j.weller@uke.de

Undersøgelse Kontakt Backup

Studiesteder

  • Tyskland
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Tyskland, 20251
        • Rekruttering
        • University Medical Center Hamburg-Eppendorf
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A 1
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.
Adfærdsmæssigt: Ketogenic Drinks
Ketone Performance, DeltaG
Eksperimentel: Arm A2
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.
Adfærdsmæssigt: Ketogenic Drinks
Ketone Performance, DeltaG
Eksperimentel: A3
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.
Adfærdsmæssigt: Ketogenic diet

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
Ingen indgriben: A4
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.
Eksperimentel: B1
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.
Adfærdsmæssigt: Ketogenic Drinks
Ketone Performance, DeltaG
Eksperimentel: B2
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.
Adfærdsmæssigt: Ketogenic Drinks
Ketone Performance, DeltaG
Eksperimentel: B3
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.
Adfærdsmæssigt: Ketogenic Drinks
Ketone Performance, DeltaG
Eksperimentel: B4
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.
Adfærdsmæssigt: Ketogenic diet

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
Ingen indgriben: B 5
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and Tolerability
Tidsramme: 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).
Day 0 to 28 of the intervention
CAR-T-Cell Expansion
Tidsramme: Day 7 after infusion
Number of CAR-T-Cells per ml of blood
Day 7 after infusion
Effector Cytokines
Tidsramme: Day 1 or 3 after bispecfiic antibody treatment
Protein abundance per ml of blood or cytokines signature of effector cells
Day 1 or 3 after bispecfiic antibody treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Efterforskere

  • Ledende efterforsker: Joseph Tintelnot, MD, Universitätsklinikum Hamburg-Eppendorf

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. januar 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

26. april 2026

Først indsendt, der opfyldte QC-kriterier

26. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-101551-BO

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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