This trial is testing which types of anticancer treatments can be safely combined with Belantamab Mafodotin (GSK2857916). It is also testing which doses of Belantamab Mafodotin combined with anticancer treatments are better at treating myeloma than Belantamab Mafodotin on its own.
This trial is currently open and accepting patients.
This trial is randomized, which means that you will be randomly placed into different groups, and this will determine which study drugs you receive.
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 which drugs you will be receiving.
This trial is organized into a series of sub-studies. Each individual sub-study will be testing the combination of Belantamab Mafodotin and one of the other anti-cancer therapies being used. Participants will be randomized in this study, which means that neither the patients nor the clinical trial team will be able to choose which sub-study, dose-level, or phase they participate in. Each individual sub-study will be conducted in two phases:
Treatments in this trial are organized in 21 day cycles, with patients receiving Belantamab Mafodotin and the other anticancer treatments on day 1 of each cycle as intravenous infusions. In some sub-studies, the second anti-cancer treatment may be in the form of tablets for patients to take both at the hospital and at home between hospital visits. Patients can continue to receive experimental treatments until their myeloma gets worse, or they develop bad side effects.
During the first four cycles of this trial, patients must also visit an opthalmologist for eye exams every three weeks. During the entire time patients are a part of this trial, they may not wear contact lenses.
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.
Phase 2
Enrollment: 464 patients (estimated)
View MoreDecember 13, 2021
A total of 23 patients treated with belamaf + aICOS were included in this preliminary analysis. The median (range) of prior lines of therapy was 5 (3–10). The majority of patients (21 [91%]) had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0–1 and the remainder (2 [9%]) had an ECOG PS of 2. Thirty percent of patients (n=7) had high-risk cytogenetics, and no patients had extramedullary disease.
The preliminary overall clinical response rate for the total population was 48% (n=11; 95% CI: 26.8–69.4), with 26% of patients (n=6) achieving a very good partial response or better (Table).
Nineteen patients (83%) of the total population experienced an adverse event (AE) related to study treatment and 12 patients (52%) experienced Grade ≥3 AEs related to study treatment. A total of 16 patients (70%) in the total population experienced any grade ocular AEs while 9 patients (39%) had Grade ≥3 ocular AEs related to study treatment. Only 2 patients (1 each from cohorts A and B) permanently discontinued study treatment due to AEs. Dose reductions and delays were used to manage AEs in several patients (Table).
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.
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Madison, WI
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