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A Phase 3 Randomized Study Comparing VRd Therapy followed by Ciltacabtagene Autoleucel, a CAR-T Therapy Directed Against BCMA vs VRd followed by Lenalidomide & Dexamethasone Therapy in Newly Diagnosed Multiple Myeloma for Whom HSTC is Not Planned

Clinical Trial Details

This clinical trial is for adult participants who have newly diagnosed multiple myeloma (MM).
The purpose of this study is to see if the drugs Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by the investigational drug JNJ-68284528 (cilta-cel) is safe and useful for treating participants with newly diagnosed multiple myeloma, as compared with the use of VRd followed by Lenalidomide and Dexamethasone (Rd) therapy.
JNJ-68284528 (cilta-cel) is approved by the U.S. Food and Drug Adminstration (FDA) for the treatment of relapsed or refractory multiple myeloma. Bortezomib, Lenalidomide, and Dexamethasone (VRd) are also approved by the FDA, but the combination of VRd + cilta-cel is investigational, meaning it is not yet approved by the FDA.

In this type of study treatment, participant’s white blood cells (which are a part of the immune system) will be genetically modified. JNJ-68284528 (cilta-cel) is developed to recognize a protein called B-cell maturation antigen (BCMA), which is found at high levels on multiple myeloma cells. When the cilta-cel CAR-T cells bind to the BCMA protein on the multiple myeloma cell, it allows the CAR-T cells to attack the multiple myeloma cells.
Participants will receive 5-6 cycles of VRd therapy before being randomized into 1 of the 2 study treatment groups: Arm A (VRd + Rd) or Arm B (VRd + cilta-cel). Therefore, not all participants will receive cilta-cel. Participants will have an equal chance of being assigned to either group.
Cilta-cel will be given once through a tube (intravenous catheter, IV) into a vein. Bortezomib is a liquid that will be injected using a needle into the skin, or as an IV, where it will be put into a vein in the arm through a small tube attached to a needle. Lenalidomide is a capsule taken orally at the same time daily, with or without food. Dexamethasone is a tablet taken orally, with or immediately after a meal or snack, and preferably in the morning.
Participants will be followed for approximately 10 years. The duration of participation will depend on how participants respond to the study therapy. After this study ends, participants in Arm B (CART experimental arm) will continue to be monitored for up to 15 years after receiving cilta-cel, in a separate follow up study.

Key Eligibility: 
  1. Adults with documented diagnosis of multiple myeloma
  2. Those who are ineligible for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to advanced age, presence of comorbid condition(s), or deferral of high-dose chemotherapy with ASCT as initial treatment.
  3. Cannot have prior treatment with CAR-T therapy directed at any target.

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan


Kathleen Pogonowski, RN
(646) 962-6500



Mary Palmer

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:




68284528MMY3004 (CARTITUDE-5)


Open to Enrollment

Age Group