Clinical Trial Goal
To find out:
- The highest dose of sonrotoclax that’s safe to give with carfilzomib, daratumumab, dexamethasone and pomalidomide
- If sonrotoclax in combination with carfilzomib, daratumumab, dexamethasone and pomalidomide is safe and work well to treat multiple myeloma that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have multiple myeloma that has relapsed or is refractory
- Have myeloma cells with a translocation of chromosomes 11 and 14, also known as t(11;14). Your doctor can tell you this
- Do not have any of the following:
- Non-secretory myeloma
- Plasma cell leukemia
- Solitary plasmacytoma
- Waldenström macroglobulinemia
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Carfilzomib is a small molecule inhibitor that blocks proteasome function in certain cells.
Daratumumab is a monoclonal antibody that targets CD38 on certain cells.
Dexamethasone is a drug that reduces inflammation.
Pomalidomide is a drug that blocks the growth of cancer cells.
Sonrotoclax is a drug that blocks BCL2 in certain cells.
You’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
Daratumumab is a monoclonal antibody that targets CD38 on certain cells.
Dexamethasone is a drug that reduces inflammation.
Pomalidomide is a drug that blocks the growth of cancer cells.
Sonrotoclax is a drug that blocks BCL2 in certain cells.
You’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 - Sonrotoclax plus carfilzomib, daratumumab, dexamethasone and pomalidomide
- Group 2 - Sonrotoclax plus carfilzomib and dexamethasone
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Carfilzomib – Given as intravenous (IV) infusions 1 time each week
- Daratumumab - Group 1 only - Given as a shot under your skin 1 time each week
- Dexamethasone - Given as IV infusions or as a pill you take by mouth 1 time each week
- Pomalidomide - Group 1 only - A pill that you take by mouth 1 time each day
- Sonrotoclax – A pill that you take by mouth 1 time each day. The dose you'll get depends on when you start the trial and how safe it has been
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to about 4 years.
The Food and Drug Administration (FDA) not yet approved BGB-111417. It has approved all the other drugs in this trial.
The Food and Drug Administration (FDA) not yet approved BGB-111417. It has approved all the other drugs in this trial.
Locations
Sponsors
lead: BeOne Medicines
