Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
GlaxoSmithKline
Study ID
NCT07217184
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.
  • Isatuximab — DRUG
    Isatuximab will be administered.

Study Details

The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the 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 29, 2021
Status verified
Oct 2025
Primary completion
Apr 17, 2025
Completion
Mar 11, 2027

Study Design

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

Arms

  • Experimental: Belantamab mafodotin + Isatuximab

Primary Outcome Measure

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

Locations (4)

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

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