Belantamab Mafodotin + Pd vs Bortezomib + Pd for Multiple Myeloma

(DREAMM 8 Trial)

This trial tests two different treatment combinations for people with multiple myeloma that has returned or resisted previous treatments. One group will receive belantamab mafodotin (an antibody-drug conjugate) with pomalidomide and dexamethasone, while the other will receive bortezomib with pomalidomide and dexamethasone. The trial aims to determine which combination is more effective and safer for managing this type of cancer. People previously treated for multiple myeloma, especially with lenalidomide, whose cancer has returned or not responded, might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial requires that you stop taking any systemic anti-myeloma therapy, including chemotherapy and systemic steroids, within 14 days before starting the study drug. If you have been treated with a monoclonal antibody drug, you must wait 30 days before starting the study drugs.

The trial requires that you stop any systemic anti-myeloma therapy, including chemotherapy and systemic steroids, at least 14 days before starting the study drug. If you have been treated with a monoclonal antibody drug, you must wait 30 days before starting the study drugs.

Research has shown that the combination of belantamab mafodotin, pomalidomide, and dexamethasone has been studied for treating multiple myeloma and is generally well-tolerated. Some patients have reported common side effects like vision changes and low blood counts, but these can often be managed.

Bortezomib, another treatment in the trial, has already received FDA approval for multiple myeloma and has a known safety record. It is usually well-tolerated, though some patients may experience side effects like nausea, tiredness, and nerve pain.

Researchers are excited about these treatments for multiple myeloma because they bring new approaches to tackling the disease. Belantamab mafodotin is unique because it is an antibody-drug conjugate that targets the BCMA protein on myeloma cells, delivering a potent chemotherapy directly to the cancer cells. This targeted approach could lead to more effective treatment with fewer side effects compared to standard therapies like Lenalidomide. On the other hand, Bortezomib, combined with Pomalidomide and Dexamethasone, is a well-established regimen that works by inhibiting proteasomes, which are crucial for cancer cell survival. Together, these approaches offer promising options that could improve outcomes for patients with multiple myeloma.

This trial will compare two treatment combinations for relapsed or refractory multiple myeloma. Participants in one arm will receive belantamab mafodotin with pomalidomide and dexamethasone. Studies have shown that this combination can be effective, helping nearly half of the patients by reducing cancer signs and allowing them to live for about 3.8 months without disease progression. Participants in the other arm will receive bortezomib with pomalidomide and dexamethasone, a well-known treatment combination effective in managing multiple myeloma symptoms. Both combinations aim to control the disease and improve patients' quality of life.⁶⁷⁸⁹¹⁰