A Phase 3 Study Comparing VRd (Bortezomib, Lenalidomide, and Dexamethasone) Followed by Cilta-Cel CAR T Cell Therapy versus VRd Followed by Rd (Lenalidomide and Dexamethasone) in People with Multiple Myeloma


Full Title

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 (CARTITUDE-5)


A standard treatment for newly diagnosed multiple myeloma includes the drugs bortezomib, lenalidomide, and dexamethasone (abbreviated VRd) followed by lenalidomide and dexamethasone (Rd). In this study, researchers want to learn if giving a CAR T cell therapy called JNJ-68284528 (also known as ciltacabtagene autoleucel or “cilta-cel”) after standard VRd is more effective than giving Rd after VRd.

Cilta-cel is made in a laboratory using white blood cells (called T cells) collected from a patient. The T cells are modified so they can recognize and kill multiple myeloma cells. Participants in this study will be randomly assigned to receive VRd followed by either Rd or a single dose of cilta-cel. Bortezomib is given as a subcutaneous (under the skin) injection, lenalidomide and dexamethasone are taken orally (by mouth), and cilta-cel is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must be newly diagnosed with multiple myeloma and not be candidates for high-dose chemotherapy with autologous stem cell transplantation.
  • Prior CAR T cell therapy is not permitted.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Saad Usmani at 646-608-2091.




Phase III (phase 3)

Disease Status

Newly Diagnosed



ClinicalTrials.gov ID