Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t(11;14) Multiple Myeloma

Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study ID
NCT05853965
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Jun 28, 2023
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Belantamab Mafodotin 1.9 mg/kg Q6W Venetoclax 400mg QD
  • Experimental: Cohort 2
    Belantamab Mafodotin 1.9 mg/kg Q6W Venetoclax 800mg QD
  • Experimental: Cohort 3
    Belantamab Mafodotin 1.9 mg/kg Q6W Venetoclax 400mg QD Dexamethasone 40mg Q1W (20mg for subjects ≥ 75 years)
  • Experimental: Cohort 4
    Belantamab Mafodotin 1.9 mg/kg Q6W Venetoclax 800mg QD Dexamethasone 40mg Q1W (20mg for subjects ≥ 75 years)

Primary Outcome Measure

Recommended Phase II dose (RP2D) [ Time Frame: approx. 9 months ]

Central Contacts

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