Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
GlaxoSmithKline
Study ID
NCT04126200
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin will be administered.
  • GSK3174998 — DRUG
    GSK3174998 will be administered.
  • Feladilimab — DRUG
    feladilimab will be administered.
  • Nirogacestat — DRUG
    Nirogacestat will be administered.
  • Dostarlimab — DRUG
    Dostarlimab will be administered.
  • Isatuximab — DRUG
    Isatuximab will be administered.
  • Lenalidomide — DRUG
    Lenalidomide will be administered.
  • Dexamethasone — DRUG
    Dexamethasone will be administered.
  • Pomalidomide — DRUG
    Pomalidomide will be administered.

Study Details

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

Key Dates

Start date
Oct 7, 2019
Status verified
Apr 2026
Primary completion
Apr 17, 2025
Completion
Mar 11, 2027

Study Design

Enrollment
208 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)
  • Experimental: Belantamab mafodotin+feladilimab dose exploration (Sub-study 2)
  • Experimental: Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3)
  • Experimental: Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4)
  • Experimental: Belantamab mafodotin+isatuximab dose exploration (Sub-study 5)
  • Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6)
  • Experimental: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7)
  • Active Comparator: Belantamab mafodotin monotherapy cohort expansion
  • Experimental: Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)
  • Experimental: Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)
  • Experimental: Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3)
  • Experimental: Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4)
  • Experimental: Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5)
  • Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6)
  • Experimental: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7)

Primary Outcome Measure

Number of Participants Randomized Across Sub-studies [ Time Frame: Day 1 ]

Locations (5)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteAtlantaGeorgia30322-
GSK Investigational SiteIndianapolisIndiana46202-
GSK Investigational SiteBostonMassachusetts02215-
GSK Investigational SiteGrand RapidsMichigan49546-
GSK Investigational SiteMadisonWisconsin53792-

Find similar trials in Atlanta, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
GSK Investigational Site· Atlanta, GAGSK Investigational Site· Indianapolis, INGSK Investigational Site· Boston, MAGSK Investigational Site· Grand Rapids, MIGSK Investigational Site· Madison, WI

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