top of page
  • Active, not recruiting

NCT03525678: Phase 2 - Two Doses of GSK2857916 in Myeloma who have failed Anti-CD38 Ab. DREAMM 2

Updated: Sep 19, 2022

DREAMM 2

DREAMM 2

Relapsed & Refractory Multiple Myeloma


A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody


Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.


A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody


Sponsor

GlaxoSmithKline

 

ClinicalTrials.gov Identifier: NCT03525678

Official Title:A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)

First Posted: May 16, 2018

Click here to see details on ClinicalTrials.gov


DREAMM Clinical Trial Program (dreammtrials.com)

 

Belantamab mafodotin : National Cancer Institute

Belantamab mafodotin : MedlinePlus Drug Information

GSK2857916

 

Drug: Belantamab mafodotin frozen liquid

Drug: Belantamab mafodotin lyophilized powder

 

Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study

PMID: 31859245; Lancet Oncol; Feb 2020

Click here to see details.


Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study

PMID: 34314018; Cancer; July 2021

Click here to see details.

 

OAB-049 - Impact of baseline ocular conditions (BOCs) on belantamab mafodotin (belamaf)–related corneal events in patients (pts) with relapsed or refractory multiple myeloma (RRMM)


#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


#IMS2022 - 19th International Myeloma Society Annual Meeting; Aug 25-27, LA California (themyelomaclinicaltrials.com)

 

Locations

United States, Connecticut

United States, Georgia

United States, Illinois

United States, Indiana

United States, Kansas

United States, Louisiana

United States, Maryland

United States, Massachusetts

United States, Minnesota

United States, New York

United States, North Carolina

United States, Ohio

United States, Pennsylvania

United States, Tennessee

United States, Texas

United States, Utah

United States, Washington

United States, Wisconsin

Australia, South Australia

Australia, Victoria

Canada, Alberta

Canada, Manitoba

Canada, Ontario

Europe

United Kingdom

France

Germany

Italy

Spain


 

RELATED POSTS


DREAMM-1

NCT02064387: Phase 1 -Safety Pharm.kinetics Pharm.dynamics Img. & Cl. Activity GSK2857916 - DREAMM-1

Click here for details


DREAMM-2

NCT03525678: Phase 2 - Two Doses of GSK2857916 in Myeloma who have failed Anti-CD38 Ab. DREAMM 2

Click here for details


DREAMM-3

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

Click here for details


DREAMM-4

NCT03848845: Phase 1/2: GSK2857916 in Combination With Pembrolizumab in RRMM Myeloma- DREAMM 4

Click here for details


DREAMM-5

NCT04126200: Phase 1/2 - Belantamab Mafodotin as Monotherapy & With Anti-cancer Rx (RRMM) (DREAMM 5)

Click here for details


DREAMM-6

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

Click here for details


DREAMM-7

NCT04246047: Phase 3: Belantamab Mafodotin, Bortezomib and Dex RRMM Myeloma (DREAMM 7)

Click here for details


DREAMM-8

NCT04484623: Phase 3 - Belantamab Mafodotin & Pom/Dex (Pd) Vs Bortezomib & Pd in Ref. MM (DREAMM 8)

Click here for details


DREAMM-9

NCT04091126: Phase 1 - Belantamab Mafodotin + Standard of Care New Multiple Myeloma (DREAMM 9) NDMM

Click here for details


DREAMM-12

NCT04398745: Phase 1: Belantamab Mafodotin With Normal and Varying Degree of Impaired Renal Function

Click here for details


DREAMM-13

NCT04398680: Phase 1: Belantamab Mafodotin With Normal & Impaired Hepatic Function (DREAMM 13) RRMM

Click here for details


DREAMM-14

NCT05064358: Phase 2 - Alternative Dosing Regimens of Belantamab Mafodotin RRMM - (DREAMM 14)

Click here for details

 

NCT038282: Phase 1 - Dose Esc Study Belantamab mafodotin (GSK2857916) in Japanese With Refr MM

Click here for details


NCT03715478: Phase 1/2: Multi-Center Study of GSK2857916 With Pomalidomide & Dex - Algonquin trial

Click here for details


NCT04680468: Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant & Maintenance

Click here for details


NCT04822337: Phase 1/2 - Study of Carfilzomib, Len, Dex & Belantamab Mafodotin in Multiple Myeloma

Click here for details


NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma

Click here for details


NCT04808037: Phase 1/2: Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM (BelaRd)

Click here for details


NCT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide

Click here for details


AMaRC 19-02 - BelaCarD - Phase I/II - Study of combination belantamab maf, carfilzomib, Dex RRMM

Click here for details


NCT03732703: Phase 1/2: Myeloma-Developing Regimens Using Genomics (MyDRUG)

Click here for details