This study will investigate the effects of a new treatment, GSK2857916, in patients with multiple myeloma (MM). Overall response will be the main outcome measured.
The details
There are many treatment options for MM. However, some patients do not respond to treatments or relapse. New therapies are being developed for these patients. Antibody treatments which target an MM-related protein CD38 are being developed. GSK2857916 is a new treatment which may be effective in such cases.
This study will examine the safety and effectiveness of GSK2857916 in patients with relapsed or unresponsive MM. This study will measure the overall response in the 2 years after treatment.
Who are they looking for?
This study will include 155 participants with relapsed or unresponsive MM. Both male and female participants must use adequate contraception during the study and for at least 80-140 days after taking part. Patients who have undergone stem cell transplant must have done so at least 100 days before taking part and must not have any infections. Patients must have adequate kidney, liver, and bone marrow function tests and should not have any side effects left from previous treatments.
Those who have taken an anti-myeloma drug or the trial drug in the 2 weeks before the study and those who have received stem cells from a donor will not be included. Those with internal bleeding or who have had a major study in the 4 weeks before the start of the study will not be included. Those who have previously had an allergic reaction to GSK2857916 or any of the ingredients in GSK2857916 cannot participate. Patients with other cancers, liver disease, active infections (including HIV or hepatitis), pregnant or nursing women cannot participate.
How will it work
This study will include three groups. Patients in group 1 will receive frozen liquid GSK2857916 at a dose of 2.5 mg/kg. This will be administered by a pump every 3 weeks. Patients in group 2 will receive frozen liquid GSK2857916 at a dose of 3.4 mg/kg. This will be administered by a pump every 3 weeks. The remaining participants will receive lyophilized (freeze-dried) GSK2857916.
Treatment in all groups will continue until patients experience cancer worsening, death or starting a new anti-cancer drug, for up to 2 years.
