A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd)followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) TherapyDirected Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd)

Contact:

NCT Number:

Protocol:

AAAT8402

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

The purpose of this study is to see if Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by cilta-cel is safe and useful for treating patients with newly diagnosed Multiple Myeloma, as compared with the use of VRd followed by Lenalidomide and Dexamethasone (Rd) therapy. Cilta-cel is a CAR-T cell therapy. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become cilta-cel and used to treat your multiple myeloma. After pre-randomization therapy you will be assigned randomly into either Arm A or Arm B of the study. If you are assigned to Arm A you will receive VRd treatment followed by Rd. If you are assigned to Arm B you will receive VRd treatment and cilta-cel.

Are you Eligible? (Inclusion Criteria)

  • Are you 18 years of age or older?
  • Have you been diagnosed with Multiple Myeloma?
  • Are you unable to be considered for high-dose chemotherapy with autologous stem cell
  • transplantation?

Specialty Area(s)

Multiple Myeloma/Amyloidosis, Immunotherapy

Principal Investigator

Profile Headshot
  • Director of Translational Research, Blood and Marrow Transplantation Program
  • Director of the Cell Therapy Program

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032