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.
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 ophthalmologist (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.
Phase 1/2
Enrollment: 152 patients (estimated)
View MoreThe 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.
December 05, 2020
For the 18 patients receiving 2.5 mg/kg of belamaf every 3 weeks with standard-of-care bortezomib and dexamethasone, there was an overall response rate (ORR) of 78% (95% CI, 52.4%-93.6%), with very good partial response in 9 patients (50%) and partial response in 5 patients (28%). Minimal response was observed in 1 patient and 3 patients (17%) had stable disease. There was also a clinical benefit rate of 83% (95% CI, 58.6%-96.4%). The median duration of response was not reached at a median of 18.2 weeks (range, 6.0-46.4) of treatment.
Of the patients with prior exposure to bortezomib, the ORR was 75%, and those with exposure to daratumumab (Darzalex) had an ORR of 67%; the clinical benefit rates were 81% and 67%, respectively.
Response rates increased for those treated in earlier lines of therapy. The ORR was 100% for patients treated in the second line compared with 50% for those who had received more than 3 prior lines of therapy.
All of the patients on the trial had treatment-related adverse events (AEs), although there were no new safety signals to date. Grade 3/4 AEs were seen in 16 patients (89%) and treatment-related serious AEs were seen in 5 (28%). No patients had any grade 5 AEs of interest. Serious AEs were reported in 67% and were considered related to treatment in 28%.
May 27, 2020
View all clinical trial locations sorted by state.
Goodyear, AZ
Lansing, MI
St. Louis, MO
Grand Island, NE
East Setauket, NY
Greenville, SC
Dallas, TX
January 25, 2021
GSK recognises that there may be circumstances when it is appropriate for Healthcare Professionals to give their patients Investigational medicines to treat life threatening or seriously debilitating diseases/conditions where no satisfactory alternatives exist.
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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