What is the purpose of this trial?
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage of all cancers and for 10% of all hematologic malignancies. Subjects with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of GSK2857916 monotherapy. Subjects will be treated with GSK2857916 monotherapy until disease progression or unacceptable toxicity and will be followed for Progression Free Survival (PFS) and Overall survival (OS). The subjects will be randomized to receive either frozen GSK2857916 at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg Intravenous (IV). There will be an independent cohort of subjects who will receive a lyophilized configuration of GSK2857916. Approximately 155 subjects will be enrolled in the study of which 130 subjects will be enrolled to receive frozen GSK2857916 and 25 subjects will be enrolled in the independent lyophilized drug product cohort. The subjects 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.
Start Date: 12/19/2018
End Date: 06/30/2019
Last Updated: 12/20/2018
Study HIC#: 2000023401