Phase 2 Study of Different Sequences of Cilta-cel CAR T-Cell Therapy Plus Talquetamab, Daratumumab, and Other Medications, With or Without Teclistamab, in People With Newly Diagnosed Multiple Myeloma

Full Title

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination with Daratumumab SC (Tal-D) and Teclistamab SC in Combination with Daratumumab SC (Tec-D) Following Induction with Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants with Standard-risk Newly Diagnosed Multiple Myeloma

Purpose

Researchers are comparing different sequences of therapy for people with newly diagnosed multiple myeloma. All participants will get cilta-cel CAR T-cell therapy, a form of immunotherapy made from your own white blood cells.

If you take part in this study, you will be randomly assigned to get either:

  • Cilta-cel, talquetamab, daratumumab, bortezomib, lenalidomide, and dexamethasone. You will get a short course of chemotherapy with cyclophosphamide and fludarabine to prepare your body for cilta-cel.
  • The same treatment as above with the addition of teclistamab.

Doctors want to see how well the treatments work to achieve minimal residual disease (hardly any cancer cells left). They also want to see if they work well to delay the time before the disease starts to grow again.

Who Can Join

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

  • Have newly diagnosed standard-risk multiple myeloma (does not have an increased risk of coming back after treatment).
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 to 70 years old.

Contact

For more information or to see if you can join this study, please call Dr. Sridevi Rajeeve’s office at 646-608-4310.

Protocol

24-386

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06577025