A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as initial therapy
Sponsor: |
Janssen Research & Development |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAT8402 |
U.S. Govt. ID: |
NCT04923893 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
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.
This study is closed
Investigator
Ran Reshef, MD
Are you at least 18 years old? |
Yes |
No |
Have you been diagnosed with Multiple Myeloma? |
Yes |
No |