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

Part of paid clinical trials in Yuma, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT04246047
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 is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

Key Dates

Start date
May 7, 2020
Status verified
Apr 2026
Primary completion
Oct 2, 2023
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)
  • Active Comparator: Daratumumab and Bortezomib plus Dexamethasone (Arm B)

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 41 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteYumaArizona85364-
GSK Investigational SiteDenverColorado80218-
GSK Investigational SiteKansas CityKansas66205-
GSK Investigational SiteFairfieldOhio45242-
GSK Investigational SiteTylerTexas75702-

Find similar trials in Yuma, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
GSK Investigational Site· Yuma, AZGSK Investigational Site· Denver, COGSK Investigational Site· Kansas City, KSGSK Investigational Site· Fairfield, OHGSK Investigational Site· Tyler, TX

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