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
Study of VRd Followed by Cilta-cel vs. VRd Followed by Rd Therapy in Patients with Newly Diagnosed Multiple Myeloma
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
Additional Study Information: 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
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with Multiple Myeloma? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162