This trial is testing GSK2857916 (Belantamab Mafodotin) with two different of Standard of Care (SoC) regimens; Lenalidomide + Dexamethasone or Bortezomib + Dexamethasone. Researchers are testing which dose and schedule is the safest and works best to treat your cancer.
This trial is currently open and accepting patients.
This trial is being run in two phases:
Part 1: Dose Escalation (Phase 1) - Researchers in this phase are trying to determine the highest dose of GSK2857916 that can be tolerated with the least side effects. Patients in this part of the trial will be assigned into two different arms and receive increasing doses of GSK2857916 in combination with Standard of Care drugs.
Part 2: Dose Expansion (Phase 2) - Researchers in this part are testing the safety and effects of GSK2857916 in a larger group of patients. Patients in this part of the study will also be separated into two arms and each arm will receive GSK2857916 (as either a single or split dose) in combination with the Standard of Care drugs.
The arm you’re assigned is determined by you and your doctor. However, this trial is non-randomized, and sequentially assigned, which means that the dose level and dosing schedule (single or split) you are placed in will be determined by when you join the study.
This trial is open label, which means that both you and the researchers running the study will know which group you are placed in, and the dose of the study drugs you are receiving.
During the first 4 doses of GSK2857916, you will also need to visit an opthalmologist (eye doctor) every 3 to weeks for eye examinations depending on your study arm. These visits may continue at the same frequency after the first 4 doses if you have certain side effects in your eyes; but if you don’t have side effects in your eyes, these exams can be reduced to once every 12 weeks.
You may be in the study as long as you are receiving benefit without intolerable side effects from treatment with GSK2857916, unless you decide to stop participating in the study or the study ends.
Enrollment: 123 patients (estimated)View More
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.
May 27, 2020
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Grand Island, NE
East Setauket, NY
Read the latest news and updates on this trial.
July 14, 2020
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.
January 21, 2020
March 21, 2019
Median progression-free survival extends to twelve months
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