Clinical Trial Goal
To find out if teclistamab is safe and works well to treat high-risk smoldering multiple myeloma
You may be able to join this trial if you:
- Are 18 years or older
- Have smoldering multiple myeloma that doctors consider high-risk
- Have not had any treatments for the smoldering multiple myeloma in the las 6 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Dexamethasone is a drug that reduces inflammation.
Lenalidomide is a drug that blocks growth of cancer 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.
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 – Teclistamab
- Group 2 – Dexamethasone plus lenalidomide
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:
- Teclistamab – Group 1 only - Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Dexamethasone– Group 2 only - 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
- Lenalidomide– Group 2 only - 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
You may continue treatment for up to 2 years. You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using teclistamab in this way to treat smoldering multiple myeloma is new and unproven.
Contacts
Irene Ghobrial, MD, 617-632-4198, Irene_ghobrial@dfci.harvard.edu
Ashlee Sturtevant, MSc, 617-632-4101, Ashlee_Sturtevant@DFCI.harvard.edu
Locations
Colorado Blood Cancer InstituteRECRUITING
Denver, Colorado
Jeffrey Matous, MD, jeffrey.matous@healthonecares.com
Dana Farber Cancer InstituteRECRUITING
Boston, Massachusetts
Irene M Ghobrial, MD, 617-632-4198, Irene_Ghobrial@dfci.harvard.edu
Oregon Health & Science UniversityRECRUITING
Portland, Oregon
Eva Medvedova, MD, medvedov@ohsu.edu
Sponsors
collaborator: Janssen Research & Development, LLC, lead: Irene Ghobrial, MD
