About the Study

Multiple myeloma is a rare and currently incurable cancer. Although there have been significant advances made in treatment, many multiple myeloma patients still relapse or develop treatment resistance. There is an urgent need to develop new treatments that work differently.

The purpose of this study is to see how safe and effective belantamab mafodotin in combination with pomalidomide and dexamethasone is compared to pomalidomide in combination with bortezomib and dexamethasone (bor/dex) for the treatment of relapsed/refractory multiple myeloma.

If you meet the requirements for being in the study and you decide to join the study, you will be assigned to a treatment arm randomly. In other words, you cannot choose which treatment you will receive. There is a 50% chance that you will be assigned to Treatment Arm A and a 50% chance that you will be assigned to Treatment Arm B. This will determine what study treatment you will receive and how often you will return to the study site for clinic visits.

You may be in the study as long as you are receiving benefit and able to tolerate your study treatment, unless you decide to stop participating in the study or the study ends.

Although your participation is completely voluntary and you may choose to leave the study at any time, it is important to know that your ongoing commitment to the dreaMM8 study is a key element in helping researchers find potential treatment options for people living with multiple myeloma around the world.

What is the study drug?

Belantamab mafodotin (the study drug) is an investigational drug being tested as a potential treatment for relapsed/refractory multiple myeloma. It is made up of an antibody that targets the B-cell maturation antigen (BCMA) — a protein found on the surface of myeloma cells. Belantamab mafodotin is bound to the cancer-killing agent monomethyl auristatin-F (MMAF). Once the antibody binds to cancer cells containing the BCMA protein on their surface, MMAF is released into the cancer cells and acts to stop them.

What will happen during the study?

Screening period

Before you can be considered for this study, you will need to sign an Informed Consent Form. You will then have screening tests that will include blood, bone marrow, urine, and imaging tests. The study doctor and staff will ask you about your medical history and conduct a physical exam and an eye exam. It may take up to 4 weeks to get test results to see if you meet all requirements for being in the study.

Study treatment period

Your treatment will be given in cycles. This means you will receive treatment for a given period of time, and then you will have a drug-free break before starting treatment again. Clinic visits and frequency of treatment will depend on which treatment arm you are in.

If you are in Treatment Arm A, your study treatment will be in 28-day cycles. You will:

• Receive belantamab mafodotin by intravenous infusion at clinic visits on the first day of each cycle.
• Take pomalidomide orally for the first 21 days of each cycle.
• Take dexamethasone orally on Days 1, 8, 15, and 22 of each cycle.

If you are in Treatment Arm B, your study treatment will be in 21-day cycles. You will:

• Take pomalidomide orally for the first 14 days of each cycle.
• Receive bortezomib as a subcutaneous (under the skin) injection 4 times during each cycle for the first 8 cycles and then 2 times during each cycle after that.
• Take dexamethasone orally on the day of and the day after you receive bortezomib.

Your study treatment will continue as long as you are receiving benefit and able to tolerate the treatment, unless you decide to stop participating in the study or the study ends.

You will receive study treatment at clinic visits and will be given oral medication that you will take at home. Other study activities will vary from visit to visit and may include:

• Discussions about your health and medications you may take outside the study
• Measurement of vital signs (blood pressure, heart rate, body temperature)
• Blood tests
• Physical exam
• Questionnaires (on a tablet)
• Eye exam
• Body scans (for example, Xray, MRI, PET-CT)
• Disease assessments (these are to see how well your treatment is working)

What will be expected of me during the study?

The study doctor and staff will explain exactly what you can expect as a study participant and what will be expected of you. Among other responsibilities and commitments, you will need to:

• Have your assigned study treatment according to the schedule for your study treatment arm (Treatment Arm A or B)
• Take oral medication at home
• Keep a medication diary
• Use eye drops and NOT wear contact lenses, if assigned to Treatment Arm A
• Follow instructions from the study doctor and study staff
• Attend all of your clinic visits and complete the scheduled activities
• Tell the study doctor and staff about any changes in your health
• Follow all requirements related to lifestyle issues, including contraception
• Have regular pregnancy tests if you are someone who is able to become pregnant
• Keep your contact information current with the study staff
• Understand the commitment to participating in this study
• Talk with the study doctor or staff before you begin taking any new medications or supplements during this study
• Tell the study doctor or staff if you no longer want to be in the study