A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic Function

Part of paid clinical trials in Tucson, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT04398680
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in Relapsed/Refractory Multiple Myeloma (RRMM) participants with impaired hepatic function and in matched RRMM participants with normal hepatic function.

Key Dates

Start date
Apr 20, 2021
Status verified
Nov 2025
Primary completion
Nov 4, 2025
Completion
Nov 4, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1, Group 1: Participants with normal hepatic function
    Participants with normal hepatic function (Serum bilirubin and Aspartate aminotransferase \[AST\] less than or equal to \[\<=\] Upper limit of normal \[ULN\]) will be administered with Belantamab mafodotin
  • Experimental: Part 1, Group 2: Participants with moderate hepatic impairment
    Participants with moderate hepatic impairment (Serum bilirubin greater than \>1.5 - 3 times ULN and any AST) will be administered with Belantamab mafodotin
  • Experimental: Part 2,Group 3: Participants with severe hepatic impairment
    Participants with severe hepatic impairment (Serum bilirubin \>3 times ULN and any AST) will be administered with Belantamab mafodotin

Primary Outcome Measure

Part 1 and Part 2: Maximum observed plasma concentration (Cmax) of Belantamab Mafodotin [ Time Frame: Up to 48 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteTucsonArizona85724-
GSK Investigational SiteBeverly HillsCalifornia90211-
GSK Investigational SitePlantationFlorida33322-
GSK Investigational SiteWichitaKansas67214-
GSK Investigational SiteBaltimoreMaryland21201-1595-
GSK Investigational SiteMonroevillePennsylvania15146-
GSK Investigational SiteThe WoodlandsTexas77380-
GSK Investigational SiteMilwaukeeWisconsin53233-

Find similar trials in Tucson, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
GSK Investigational Site· Tucson, AZGSK Investigational Site· Beverly Hills, CAGSK Investigational Site· Plantation, FLGSK Investigational Site· Wichita, KSGSK Investigational Site· Baltimore, MDGSK Investigational Site· Monroeville, PA

Related Studies