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New treatment option for Multiple Myeloma (MM)
Official title BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
ClinicalTrials.gov ID: NCT07564219
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Multiple Myeloma with indication for CAR-T cell therapy with Ciltacabtagene autoleucel (target antigen: BCMA) or a BCMA-directed bispecific antibody...
- Age ≥18 years on the day the informed consent is signed.
You likely can't join if
- 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).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Free and Hanseatic City of Hamburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamburg, Free and Hanseatic City of Hamburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.