Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT04162210
Phase
PHASE3
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.
  • Pom/dex (Pomalidomide plus low dose Dexamethasone) — DRUG
    Pomalidomide and Dexamethasone will be administered.

Study Details

This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

Key Dates

Start date
Apr 2, 2020
Status verified
Mar 2026
Primary completion
Sep 12, 2022
Completion
Mar 11, 2027

Study Design

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

Arms

  • Experimental: Participants receiving Belantamab mafodotin
    Participants will receive belantamab mafodotin single agent dose on Day 1 of Q3W
  • Active Comparator: Participants receiving pom/dex
    Participants will receive pomalidomide daily on Days 1 to 21 of each 28-day cycle, with dexamethasone once weekly on Days 1, 8, 15 and 22.

Primary Outcome Measure

Progression-free Survival (PFS) Based on Investigator-assessed Response as Per International Myeloma Working Group (IMWG) [ Time Frame: Up to 27 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteTucsonArizona85715-
GSK Investigational SitePuebloColorado81008-
GSK Investigational SiteDetroitMichigan48202-
GSK Investigational SiteOmahaNebraska68130-
GSK Investigational SiteClifton ParkNew York12065-
GSK Investigational SiteCincinnatiOhio45236-
GSK Investigational SiteCorvallisOregon97330-
GSK Investigational SiteEugeneOregon97401-
GSK Investigational SiteTylerTexas75702-
GSK Investigational SiteMilwaukeeWisconsin53226-

Find similar trials in Tucson, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
GSK Investigational Site· Tucson, AZGSK Investigational Site· Pueblo, COGSK Investigational Site· Detroit, MIGSK Investigational Site· Omaha, NEGSK Investigational Site· Clifton Park, NYGSK Investigational Site· Cincinnati, OH

Related Studies