This goal of this Phase 3 clinical trial is to test how safe and effective Belantamab Mafodotin is when combined with Bortezomib, Lenalidomide, and Dexamethasone. Researchers want to determine the safest and most effective dose of Belantamab Mafodotin, and study whether it can improve your myeloma when combined with the other study drugs.
This trial is currently open and accepting patients.
This trial is seeking approximately 810 patients. Patients will receive the study drugs over 21 or 28 day cycles and can continue to receive the study drugs as long as they are benefitting from them, don’t develop bad side effects, and their myeloma does not get worse.
While participating in this study patients will need to have additional eye exams and screenings and are not allowed to wear contact lenses. Patients may need to give themselves eye drops each day as long as they are receiving Belantamab Mafodotin.
This trial is organized into two separate parts. It is open label, which means that both the patients and doctors will know which part and group they are participating in, and which drugs they are receiving. At this time, patients joining this study will be participating in Part 1.
Part 1 of the study will look at how people react to and how the body uses belantamab mafodotin at different doses when taken together with bortezomib, lenalidomide and dexamethasone. We also want to know how the combination of these drugs affects your cancer. We will give people in the study different doses of belantamab mafodotin. The other three drugs will be given at the doses allowed in the country where you are. The effects of the study drugs, both good and bad, will be studied.
There are five planned dose levels of Belantamab Mafodotin. At least three patients will receive a dose before researchers decide to give the next group of patients an increased dose of Belantamab Mafodotin.
Part 2 will use the best dose from Part 1 and study the safety and effectiveness of Belantamab Mafodotin combined with Bortezomib, Lenalidomide and Dexamethasone in a larger group of patients. Patients participating in Part 2 will be randomly separated into two groups, or arms. Arm A will receive Belantamab Mafodotin, Bortezomib, Lenalidomide and Dexamethasone. Arm B will receive Bortezomib, Lenalidomide and Dexamethasone. Researchers will then compare data from the two different groups to see if Belantamab Mafodotin can help to improve your multiple myeloma.
If you have stopped study treatment and your multiple myeloma has not gotten worse, you may have follow-up visits. If you are in Part 1, you will have one final visit 45 days after you have stopped taking the study drug. If you are in Part 2 and you have stopped taking study drug, you will be followed for overall survival up to 5 years. You may choose to stop participating in this study at any time. If your myeloma gets worse, or you develop bad side effects, researchers may remove you from the study.
Enrollment: 810 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.
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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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