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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
Janssen Research & Development, LLC
This is a randomised trial with two experimental arms for people newly diagnosed multiple myeloma for whom ASCT is not planned as initial terapy. All participants will receive bortezomib (administered subcutaneously), lenalidomide (administered orally), and dexamethasone (administered orally) (VRd) regimen for 6 cycles before randomisation.
In Experimental Arm A, participants will receive VRd+Rd (Standard Therapy). Following randomisation, these participants will receive 2 more cycles of VRd. Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.
In Experimental Arm B, participants will receive VRd+Clitacabtagene Autoleucel (Cita-cel). Following randomisation, these participants will undergo apheresis and receive two more cycles of VRd as bridging therapy. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen of cyclophosphamide (administered intravenously) and fludarabine (administered intravenously) and Cilta-cel infusion.