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NOT YET RECRUITING
NCT07903506
PHASE3

To Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

Sponsor: Kite, A Gilead Company

View on ClinicalTrials.gov

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

Interventions

DRUG

Anitocabtagene Autoleucel

A single infusion of CAR+ transduced autologous T cells

DRUG

Isatuximab

Administered subcutaneously (SC)

DRUG

Bortezomib

Administered SC

DRUG

Lenalidomide

Administered orally (PO)

DRUG

Dexamethasone

Administered orally (PO)

DRUG

Fludarabine

Administered IV

DRUG

Cyclophosphamide

Administered IV

DRUG

Melphalan

Administered intravenously (IV)