What's the purpose of this trial?

The goal of this Phase 3 clinical trial is to test how safe and effective Belantamab Mafodotin is in the treatment of relapsed/refractory myeloma. One group of patients will receive Belantamab Mafodotin, and the other will receive Pomalidomide + low dose Dexamethasone. Researchers will compare the two groups of patients to help them understand how well Belantamab Mafodotin works when compared to Pomalidomide + Dexamethasone.

This trial is currently open and accepting patients.

What's being studied?

• Belantamab Mafodotin (formerly 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 causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity (ADCC).
• Dexamethasone is a steroid given in conjunction with some cancer treatments.
• Pomalidomide is an immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.

What will happen during the trial?

This trial is seeking approximately 320 patients, and organized into two separate groups, called arms. This trial is randomized, which means patient will be randomly assigned into their group. This trial is open label, which means that both the patients and doctors will know which group they have been assigned to, and which drugs they will be receiving.

ARM 1

• This arm will receive Belantamab Mafodotin over a 21 day cycle. Patient will receive Belantamab Mafodotin by intravenous infusion on day 1. Patients will need to visit the clinic every three weeks for testing and to receive their dose of Belantamab Mafodotin.
• Patients in Arm 1 will undergo eye evaluations every three weeks for the first three cycles of the study. From cycle 4 onwards, if there are no ocular side effects, eye exams will then be given every 12 weeks.
• Patients in Arm 1 will not be permitted to use contact lenses while they are receiving Belantamab Mafodotin. Patients will be required to use lubricating eye drops 4-8 times daily, and use a cooling eye mask while receiving their infusion The study eye doctor will tell you when you can start using contact lenses again after stopping Belanatamb Mafodotin, usually this is 45 days after your last dose.

ARM 2

• This arm will receive Pomalidomide and Dexamethasone over a 28 day cycle.
  • Pomalidomide will be taken orally on days 1-21
  • Dexamethasone will be taken orally on days 1, 8, 15, and 22.
• Patients will need to visit the clinic every three weeks and at the end of each cycle.
• Patients participating in this arm will need to take medications to prevent the development of blood clots.
• Patients in this arm will need to have an eye exam during cycle 4, and then every 6 months.

Patients will receive the study drugs until they decide to stop participating, their myeloma gets worse, they develop bad side effects, die, or the study ends. If you stop participating in the study and your myeloma has not gotten worse, you will be asked to participate in follow up visits every 3 weeks. If you stop participating in the study and your myeloma has gotten worse, you will be asked to participate in a phone or email follow-up communication every 3 months until the end of the study.

Additional Trial Information

Phase 3

Enrollment: 320 patients (estimated)