Actively Recruiting
Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory T(11;14) Multiple Myeloma
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-03-30
45
Participants Needed
5
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about the safety and efficacy of the drug combination belantamab mafodotin and venetoclax, with or without the addition of dexamethasone, in patients with relapsed/refractory multiple myeloma bearing the translocation t(11;14)
CONDITIONS
Official Title
Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory T(11;14) Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of relapsed and refractory multiple myeloma with t(11;14) translocation
- ECOG performance status of 2 or less
- Documented multiple myeloma requiring treatment with measurable disease at screening
- Cytogenetics/FISH confirming t(11;14) translocation
- Received at least one prior treatment line including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Evidence of progressive disease after last treatment
- If history of autologous stem cell transplant, it must have been more than 100 days ago with no active infection
- Adequate organ function including hemoglobin ≥8.0 g/dL, neutrophil count ≥1.5 x10^9/L, platelet count ≥75 x10^9/L, liver enzymes ≤2.5 x upper limit of normal, bilirubin ≤1.5 x upper limit of normal (with exceptions), renal function with eGFR ≥30 mL/min/1.73 m², and controlled calcium levels
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or using highly effective contraception
- Male participants must agree to use effective contraception during and for 6 months after treatment
- Agreement to refrain from blood donation during and 28 days after study treatment
- Agreement not to share study medication
- Prior treatment-related toxicities must be Grade 1 or less except for alopecia
You will not qualify if you...
- Prior treatment with venetoclax or anti-BCMA therapy
- Use of investigational or approved systemic anti-myeloma therapy within 14 days before study drug, except limited corticosteroids
- Plasmapheresis or radiation therapy within 7 days before study drug
- Current corneal epithelial disease beyond mild changes
- Unstable liver or biliary disease
- Active renal conditions affecting safety
- Major surgery within 4 weeks before study drug (kyphoplasty excluded)
- Use of contact lenses during study
- Active mucosal or internal bleeding or gastrointestinal disease affecting drug absorption
- Cardiovascular risk as defined by protocol
- Known hypersensitivity to investigational drugs or components
- Invasive malignancy within 5 years except certain treated cancers
- Pregnancy or lactation
- Prior allogeneic stem cell transplant
- Symptomatic amyloidosis, active POEMS syndrome, or active plasma cell leukemia
- Serious or unstable medical or psychiatric disorders interfering with safety or study compliance
- Known HIV, hepatitis B, or hepatitis C infection
- Immune or inflammatory conditions requiring immunosuppressive treatment
- Live vaccines within 8 weeks before study drug
- Use of prohibited medications or foods during study
- Meningeal or central nervous system involvement by myeloma
- Other uncontrolled conditions interfering with study
- Inability or unwillingness to comply with study protocol
- Treatment with moderate or strong CYP3A inhibitors or inducers within 7 days before study drug
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before study drug
- Participation in other clinical trials except observational studies
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University Medical Center Hamburg-Eppendorf
Hamburg, Ham, Germany, 20246
Actively Recruiting
2
Klinikum Chemnitz
Chemnitz, Germany
Actively Recruiting
3
Uniklinik Heidelberg
Heidelberg, Germany
Actively Recruiting
4
UKSH Lübeck
Lübeck, Germany
Actively Recruiting
5
Uniklinkum Ulm
Ulm, Germany
Actively Recruiting
Research Team
K
Katja Weisel
CONTACT
L
Lisa Leypoldt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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