Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in West Palm Beach, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT05064358
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

Key Dates

Start date
Mar 3, 2022
Status verified
Apr 2026
Primary completion
Aug 19, 2024
Completion
Feb 10, 2026

Study Design

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

Arms

  • Experimental: Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
  • Experimental: Cohort 2: Participants receiving belantamab mafodotin at DL 2
  • Experimental: Cohort 3: Participants receiving belantamab mafodotin at DL 3
  • Experimental: Cohort 4: Participants receiving belantamab mafodotin at DL 4
  • Experimental: Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification

Primary Outcome Measure

Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale [ Time Frame: Up to 29.5 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteWest Palm BeachFlorida33401-
GSK Investigational SiteKansas CityMissouri64114-
GSK Investigational SiteNew YorkNew York10065-
GSK Investigational SiteChattanoogaTennessee37404-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteHoustonTexas77090-

Find similar trials in West Palm Beach, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
GSK Investigational Site· West Palm Beach, FLGSK Investigational Site· Kansas City, MOGSK Investigational Site· New York, NYGSK Investigational Site· Chattanooga, TNGSK Investigational Site· Nashville, TNGSK Investigational Site· Houston, TX

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