- 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
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
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
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
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
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