Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
GlaxoSmithKline
Study ID
NCT07150091
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.
  • Nirogacestat — DRUG
    Nirogacestat will be administered.
  • Lenalidomide — DRUG
    Lenalidomide will be administered.
  • Dexamethasone — DRUG
    Dexamethasone will be administered.

Study Details

The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat, lenalidomide, and dexamethasone, and to establish the recommended Phase 2 dose for combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).

Key Dates

Start date
Jul 19, 2022
Status verified
Aug 2025
Primary completion
Apr 17, 2025
Completion
Mar 11, 2027

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Belantamab mafodotin + Nirogacestat + Lenalidomide + Dexamethasone

Primary Outcome Measure

Dose Exploration (DE) Phase: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBostonMassachusetts02215-

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