What's the purpose of this trial?

This clinical trial is testing how effective the combination of Belantamab Mafodotin, Bortezomib and Dexamethasone is when compared to the combination of Daratumumab, Bortezomib and Dexamethasone in the treatment of relapsed/refractory multiple myeloma.

This trial is currently open and accepting patients.

What's being studied?

• Belantamab Mafodotin (GSK2857916) is an investigational product that acts as an antibody-drug conjugate (ADC) with anti-BCMA antibody that binds to BCMA on tumor cell surfaces.
• Bortezomib is a type of cancer drug called a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body.
• Daratumumab is a type of cancer drug called a monoclonal antibody that attaches to myeloma cells in your body and may directly attack them or help your immune system recognize and attack them.
• Dexamethasone is a steroid given in conjunction with some cancer treatments that also has anti-cancer activity.

What will happen during the trial?

This trial is open-label, which means that both you and researchers will know which drugs you are receiving.

This trial is organized into two separate groups, also called arms.

ARM A

• This arm will receive Belantamab Mafodotin, Bortezomib and Dexamethasone in 21 day cycles.
  • Belantamab Mafodotin will be given by intravenous infusion on Day 1 of each cycle.
  • Bortezomib will be given by subcutaneous injection on Days 1, 4, 8, and 11 for the first 8 cycles.
  • Dexamethasone will be given either as a pill or by intravenous injection on the day of and after you receive Bortezomib.
• Patients participating in Arm A will need to have their eyes examined to monitor for potential side effects. Patients will need to see an eye specialist before they receive their first dose of Belantamab Mafodotin, and then once each cycle for the next four cycles. If you don’t develop eye side effects, you may be able to decrease your eye screenings to once every 6 months.

ARM B

• This arm will receive Daratumumab, Bortezomib and Dexamethasone. During cycles 1-8, cycles will last 21 days, and cycles 9 and onward will be 28 days.
  • Daratumumab will be given by intravenous infusion on Days 1, 8, and 15 of cycles 1-3, and on Day 1 of cycles 4+.
  • Bortezomib will be given by subcutaneous infusion on Days 1, 4, 8, and 11 for the first 8 cycles.
  • Dexamethasone will be given as an intravenous injection at the first treatment and then by either a pill or by intravenous injection on the day of and after you receive Bortezomib.

Additional Trial Information

Phase 3

Enrollment: 478 patients (estimated)