A Phase 3 Study Comparing Three Combination Treatments for Newly Diagnosed Multiple Myeloma

Full Title

A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy (64007957MMY3005)

Purpose

Researchers are comparing two new combination drug treatments with the standard therapy for multiple myeloma. The people in this study have multiple myeloma that is newly diagnosed. In addition, they cannot have an autologous stem cell transplant with high-dose chemotherapy.

If you take part in this study, you will be randomly assigned to get one of these treatments:

  • Tec-DR (teclistamab, daratumumab, and lenalidomide)
  • Tal-DR (talquetamab, daratumumab, and lenalidomide)
  • DRd (daratumumab, lenalidomide, and dexamethasone), the standard treatment

Talquetamab and teclistamab bind to a cancer cell and an immune cell (T cell) at the same time. They may strengthen your immune system’s ability to fight cancer cells by activating your own cells to destroy your cancer.

Giving talquetamab or teclistamab with the other study drugs may work better than giving either drug alone. They help the immune system work in different ways than the other study drugs.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have newly diagnosed multiple myeloma.
  • Not be eligible for an autologous stem cell transplant due to older age or other health problems.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Saad Usmani’s office at 646-608-4165.

Protocol

25-103

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05552222