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NCT03544281: Phase 2: GSK2857916 /Len/Dex Vs GSK2857916/Bortezomib/Dex - RRMM Myeloma - DREAMM 6

Updated: Sep 19, 2022

NCT03544281: Phase 2: To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 6)

dreamm 6 belantamab bcma myeloma trial

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 6)


This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Arm A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study will be a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of belantamab mafodotin in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of belantamab mafodotin at selected dose levels and dosing schedules in combination with Len/Dex or Bor/Dex.


Sponsor

GlaxoSmithKline


Collaborator

Iqvia Pty Ltd

 

ClinicalTrials.gov Identifier: NCT03544281


Official Title: A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6

First Posted : June 1, 2018

Click here for details on ClinicalTrials.gov


DREAMM Clinical Trial Program (dreammtrials.com)

 

Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information


Belantamab mafodotin : National Cancer Institute

Belantamab mafodotin : MedlinePlus Drug Information

GSK2857916

 

Drug: Belantamab mafodotin

Drug: Lenalidomide

Drug: Dexamethasone

Drug: Bortezomib

 

Belantamab Mafodotin (Code C114299)

Belantamab Mafodotin

BELANTAMAB MAFODOTIN

Belantamab Mafodotin-blmf

Blenrep

GSK2857916

J6M0-mcMMAF

 

1419 DREAMM-6: Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (Belamaf) in Combination with Bortezomib/Dexamethasone (BorDex) in Relapsed/Refractory Multiple Myeloma (RRMM)

Program: Oral and Poster Abstracts

Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I

Hematology Disease Topics & Pathways:

Adult, Diseases, Therapies, Combinations, Lymphoid Malignancies, Study Population, Clinically relevant

Saturday, December 5, 2020, 7:00 AM-3:30 PM

Click here for details

 

DREAMM-6: SAFETY AND TOLERABILITY OF BELANTAMAB MAFODOTIN IN COMBINATION WITH BORTEZOMIB/DEXAMETHASONE IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM)


EHA 2020

 

Locations

United States, Alabama

United States, Arizona

United States, Georgia

United States, Indiana

United States, Michigan

United States, Missouri

United States, Nebraska

United States, New Jersey

United States, New York

United States, South Carolina

United States, Texas

Canada, Quebec

Australia, New South Wales

Australia, South Australia

Australia, Victoria

Australia, Western Australia

Europe

United Kingdom

France

Spain

 

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