All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

Sponsor
GlaxoSmithKline
Study ID
NCT06956170
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 will be administered.
  • Pomalidomide — DRUG
    Immunomodulatory drug (IMiD) will be administered.
  • Dexamethasone — DRUG
    Synthetic glucocorticoid with anti-tumor activity will be administered.
  • Bortezomib — DRUG
    Proteasome Inhibitor will be administered.

Study Details

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of combination of pomalidomide, bortezomib and dexamethasone in Japanese participants with relapsed/refractory multiple myeloma (RRMM).

Key Dates

Start date
Feb 10, 2022
Status verified
May 2025
Primary completion
May 27, 2024
Completion
Nov 30, 2029

Study Design

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

Arms

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

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 120 weeks ]

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