A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment

Sponsor
GlaxoSmithKline
Study ID
NCT07609706
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin will be administered.
  • Bortezomib — DRUG
    Bortezomib will be administered.
  • Dexamethasone — DRUG
    Dexamethasone will be administered.

Study Details

The goal of the clinical trial is to collect safety data and information on how the body processes BVd in people with multiple myeloma (MM) who have moderate liver problems, compared with similar participants who have normal liver function. It also compares how liver problems affect the body's handling of belantamab mafodotin and uses the results to help set safe and appropriate dosing guidance for MM participants with moderate liver problems.

Key Dates

Start date
Oct 23, 2026
Status verified
May 2026
Primary completion
Aug 22, 2031
Completion
Aug 22, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Normal hepatic function
  • Experimental: Moderate hepatic impairment

Primary Outcome Measure

Area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC 0-tau) of belantamab mafodotin antibody drug conjugate (ADC) [ Time Frame: Up to 3 weeks ]

Central Contacts

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