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A Trial to Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Standard of Care in Newly Diagnosed Multiple Myeloma
Sponsor: Kite, A Gilead Company
Summary
The goal of this clinical study iMMagine-4 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus quadruplet-based SOCT in participants with NDMM who are not eligible for autologous stem cell transplant (auto-SCT).
Official title: A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of Quadruplet Induction Followed by Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Newly Diagnosed Multiple Myeloma Who Are Not Eligible for Autologous Stem Cell Transplant
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2027-01
Completion Date
2042-02
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Anitocabtagene autoleucel
A single infusion of CAR+ transduced autologous T cells
Daratumumab
Administered subcutaneously (SC)
Bortezomib
Administered SC
Lenalidomide
Administered orally (PO)
Dexamethasone
Administered PO or intravenously (IV)
Fludarabine
Administered IV
Cyclophosphamide
Administered IV