Clinical Trial Goal
To find out if the combination of daratumumab, lenalidomide, and talquetamab or teclistamab, is safe and works well to treat multiple myeloma that has not yet been treated
You may be able to join this trial if you:
- Are 18 years old or older
- Have multiple myeloma and are one of the following:
- Have not yet been treated
- Are considered ineligible for blood or marrow transplant (BMT) with high-dose chemotherapy (chemo)
- 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.
Lenalidomide is a drug that blocks growth of cancer cells.
Talquetamab is a monoclonal antibody that target CD37 on certain cells.
Teclistamab is a bispecific antibody that targets BCMA and CD3 on certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
Lenalidomide is a drug that blocks growth of cancer cells.
Talquetamab is a monoclonal antibody that target CD37 on certain cells.
Teclistamab is a bispecific antibody that targets BCMA and CD3 on certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – daratumumab and lenalidomide
- Group 2 – daratumumab and lenalidomide plus talquetamab
- Group 3 - daratumumab and lenalidomide plus teclistamab
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:
- Daratumumab – 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
- Lenalidomide - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
- Talquetamab - Group 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
- Teclistamab - Group 3 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
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 9 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 not yet been treated is new and unproven.
Locations
Sponsors
lead: Janssen Research & Development, LLC
