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  • Active, not recruiting

NCT04162210: Phase 3 - Belantamab Mafodotin Vs Pomalidomide + Low-dose Dexamethasone (Pom/Dex) RRMM

Updated: Jan 27

  • DREAMM 3

  • Relapsed & Refractory Myeloma v

DREAMM 3

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


 


 

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



 

22 November 2022


GSK plc (LSE/NYSE: GSK) today announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep (belantamab mafodotin-blmf) following the request of the US Food and Drug Administration (FDA). This request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.



Conclusions: Belamaf monotherapy did not demonstrate PFS superiority when compared to a doublet (Pd). However, median PFS was longer for belamaf monotherapy and belamaf induced deeper, more durable responses than Pd. No new safety signals were observed. Subgroup analyses and PRO outcomes will be reported. Belamaf continues to be investigated in combination with established and novel agents.


 

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