Trial Details 50 Total Sites

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

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 intravenously at 2.5 milligram (mg)/kilogram (kg) on Day 1 (D1) of an every 3 weeks (Q3W) schedule. Pomalidomide will be administered orally at the approved starting dose of 4 mg daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered orally at a dose of 40 mg 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. Approximately up to 380 participants will be randomized (320 + 60 to fulfill regional country requirements).

phase

Phase 3

status

Recruiting

enrollment

380

score

49

start date

2020-04-02

last updated

2022-01-14

biomarkers

N/A

Dallas, Texas
facility
GSK Investigational Site
facility
GSK Investigational Site
2 facilities
Recruiting
Detroit, Michigan
facility
GSK Investigational Site
1 facility
Recruiting
Las Vegas, Nevada
facility
GSK Investigational Site
1 facility
Recruiting
Milwaukee, Wisconsin
facility
GSK Investigational Site
1 facility
Recruiting
Tucson, Arizona
facility
GSK Investigational Site
1 facility
Recruiting
Omaha, Nebraska
facility
GSK Investigational Site
1 facility
Recruiting
Cincinnati, Ohio
facility
GSK Investigational Site
1 facility
Recruiting
Salem, Oregon
facility
GSK Investigational Site
1 facility
Recruiting
Eugene, Oregon
facility
GSK Investigational Site
1 facility
Recruiting
Pueblo, Colorado
facility
GSK Investigational Site
1 facility
Recruiting
Tyler, Texas
facility
GSK Investigational Site
1 facility
Recruiting
Albany, New York
facility
GSK Investigational Site
1 facility
Recruiting