- Recruiting
NCT04162210: Phase 3 - Belantamab Mafodotin Vs Pomalidomide + Low-dose Dexamethasone (Pom/Dex) RRMM
Updated: Sep 19, 2022
DREAMM 3
Relapsed & Refractory Myeloma
NCT04162210: Phase 3 - Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in RRMM
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).
Sponsor
ClinicalTrials.gov Identifier: NCT04162210
Official Title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory MultipleMyeloma (RRMM) (DREAMM 3)
First Posted : November 14, 2019
Click here to see details on ClinicalTrials.gov
DREAMM Clinical Trial Program (dreammtrials.com)
Dexamethasone : National Cancer Institute
Dexamethasone : MedlinePlus Drug Information
Belantamab mafodotin : National Cancer Institute
Belantamab mafodotin : MedlinePlus Drug Information
Pomalidomide : National Cancer Institute
Pomalidomide : MedlinePlus Drug Information
Belantamab Mafodotin
GSK2857916
Belantamab Mafodotin-blmf
Blenrep
J6M0-mcMMAF
Drug: Belantamab mafodotin
Drug: Pom/dex (Pomalidomide plus low dose Dexamethasone)
Locations
United States, Arizona
United States, California
United States, Colorado
United States, Florida
United States, Michigan
United States, Nebraska
United States, Nevada
United States, New York
United States, Ohio
United States, Oregon
United States, Texas
United States, Wisconsin
Canada, Alberta
Europe
United Kingdom
France
Germany
Italy
Netherlands
Spain
Belgium
Bulgaria
Greece
Hungary
Poland
Asia
Japan
Korea, Republic of
Russian Federation
China
China, Jilin
China, Guangdong
Brazil
Australia
Australia, New South Wales
Australia, South Australia
Australia, Tasmania
Australia, Victoria
Australia, Western Australia
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