Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor
GlaxoSmithKline
Study ID
NCT07614360
Phase
PHASE2
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
  • Dexamethasone — DRUG
    Dexamethasone will be administered.
  • Bortezomib — DRUG
    Bortezomib will be administered

Study Details

The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy. The study will further characterize the risk of ocular toxicity and impact on efficacy measures and PK evaluations using alternative and approved dosing regimens.

Key Dates

Start date
Aug 3, 2026
Status verified
May 2026
Primary completion
Feb 28, 2029
Completion
Feb 11, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving Belantamab mafodotin dosing regimen 1 + Bortezomib + Dexamethasone
    Participants will receive dosing regimen 1 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone
  • Experimental: Participants receiving Belantamab mafodotin dosing regimen 2 + Bortezomib + Dexamethasone
    Participants will receive dosing regimen 2 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone.
  • Experimental: Participants receiving Belantamab mafodotin dosing regimen 3 + Bortezomib + Dexamethasone
    Participants will receive dosing regimen 3 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone.

Primary Outcome Measure

Percentage of participants with grade greater than or equal to (>=)3 corneal events assessed by keratopathy visual acuity (KVA) scale [ Time Frame: Up to approximately 4.5 years ]

Central Contacts

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