Clinical Trial Goal
To find out if elranatamab, alone or with daratumumab, is safe and works 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 been treated with the following. Your doctor can tell you this:
- Lenalidomide
- A proteasome inhibitor. Some examples include bortezomib and carfilzomib
- Do not have any of the following:
- Amyloidosis
- Plasma cell leukemia
- POEMS syndrome
- Smoldering myeloma
- Have not been treated with any of the following. Your doctor can tell you this:
- Anti-CD38 drugs in the last 6 months. Some examples include daratumumab and isatuximab
- Blood or marrow transplant (BMT) in the last 3 months
- CAR T-cell therapy
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Daratumumab is a monoclonal antibody that targets CD38 on certain cells.
Dexamethasone is a drug that reduces inflammation.
Elranatamab is a bispecific T cell engager (BiTE) antibody that targets BCMA and CD3 on certain cells.
Pomalidomide is a drug that blocks the growth of cancer cells.
In this trial, you’ll be randomized to 1 of 3 groups. Once you’re randomized, you’ll be told what group you’re in:
Dexamethasone is a drug that reduces inflammation.
Elranatamab is a bispecific T cell engager (BiTE) antibody that targets BCMA and CD3 on certain cells.
Pomalidomide is a drug that blocks the growth of cancer cells.
In this trial, you’ll be randomized to 1 of 3 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – Elranatamab
- Group 2 – Elranatamab plus daratumumab
- Group 3 - Daratumumab, dexamethasone and pomalidomide
Randomized means doctors will use a computer to assign you to a 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:
- Daratumumab - Group 2 and 3 only - Given as a shot under your skin
- Dexamethasone - Group 3 only - A pill that you take by mouth
- Elranatamab – Group 1 and 2 only - Given as a shot under your skin. The dose you'll get depends on when you start the trial and how safe it has been
- Pomalidomide - Group 3 only - A pill that you take by mouth
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) has approved all of the drugs used in this trial. Using them in this way to treat multiple myeloma that has relapsed or is refractory is new and unproven.
Locations
Sponsors
lead: Pfizer
