China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor
GlaxoSmithKline
Study ID
NCT06868654
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Belantamab mafodotin — DRUG
    Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
  • Daratumumab — DRUG
    Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody
  • Bortezomib — DRUG
    Proteasome Inhibitor
  • Dexamethasone — DRUG
    Synthetic glucocorticoid with anti-tumor activity

Study Details

This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.

Key Dates

Start date
Jul 28, 2021
Status verified
Apr 2026
Primary completion
Apr 3, 2024
Completion
Jun 30, 2028

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Belantamab mafodotin and Bortezomib plus Dexamethasone
  • Active Comparator: Daratumumab and Bortezomib plus Dexamethasone

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 32 months ]

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