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To Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
Sponsor: Kite, A Gilead Company
Summary
The goal of this clinical study iMMagine-6 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus autologous stem cell transplant in participants with newly diagnosed multiple myeloma (NDMM). The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel administered after quadruplet-based induction versus standard of care therapy (SOCT; quadruplet-based induction followed by autologous stem cell transplant (auto-SCT) in participants with NDMM who are eligible for auto-SCT.
Official title: A Phase 3, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant Following Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction in Participants With Newly Diagnosed Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2027-02
Completion Date
2042-03
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Anitocabtagene Autoleucel
A single infusion of CAR+ transduced autologous T cells
Isatuximab
Administered subcutaneously (SC)
Bortezomib
Administered SC
Lenalidomide
Administered orally (PO)
Dexamethasone
Administered orally (PO)
Fludarabine
Administered IV
Cyclophosphamide
Administered IV
Melphalan
Administered intravenously (IV)