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BELI(E)VE: Belantamab Mafodotin and Venetoclax in Relapsed/Refractory t(11;14) Multiple Myeloma
NCT05853965Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2023
- Primary completion
- Apr 2027
- Countries
- 1
- Sponsor
- University Medical Center Hamburg-Eppendorf
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, open-label trial of belantamab mafodotin and venetoclax in multiple myeloma (MM) (4 cohorts), sponsored by University Medical Center Hamburg-Eppendorf. Primary endpoint: Recommended Phase II dose at 9 months. Started Jun 2023; status: recruiting.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Cohort 1
Belantamab Mafodotin 1.9 mg/kg Q6W + Venetoclax 400mg QD
Cohort 2
Belantamab Mafodotin 1.9 mg/kg Q6W + Venetoclax 800mg QD
Cohort 3
Belantamab Mafodotin 1.9 mg/kg Q6W + Venetoclax 400mg QD + Dexamethasone 40mg Q1W
Cohort 4
Belantamab Mafodotin 1.9 mg/kg Q6W + Venetoclax 800mg QD + Dexamethasone 40mg Q1W
03
Who it enrols
Adult patients with relapsed/refractory t(11;14) multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have not received prior venetoclax or anti-BCMA treatment.
04
Endpoints
Primary
Recommended Phase II dose
Secondary
Overall Response Rate
Minimal residual disease negativity
Progression free survival
Duration of response
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