A Trial to Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Standard of Care in Newly Diagnosed Multiple Myeloma

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).

Key Inclusion Criteria: * Determined by the Investigator to be not eligible for auto-SCT * Documented newly diagnosed multiple myeloma (NDMM) according to IMWG diagnostic criteria * Measurable disease at screening per IMWG: 1. Serum M-protein level ≥ 1.0 g/dL; or 2. Urine M-protein level ≥ 200 mg/24 hours; or 3. Serum free light chain (FLC) ≥ 10 mg/dL (100 mg/L) and abnormal serum FLC ratio * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Adequate hematological function * Adequate renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria: * Any prior anti-MM therapy (including B-cell maturation antigen (BCMA)-directed therapy, CAR T-cell therapy, or genetically modified cells), with the exception of protocol-specified anti-MM stabilizing therapy and palliative radiation * Central nervous system (CNS) or meningeal involvement of MM * History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or amyloidosis * Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. * Prior allogeneic stem cell transplant * Any prior systemic treatment or radiotherapy treatment for any cancer other than MM within 24 months before randomization. * Live vaccine ≤ 4 weeks before randomization * Presence or suspicion of infection that is uncontrolled * History or presence of intracranial or CNS disorders, or CNS neoplasms (benign and malignant) * Females who are pregnant or breastfeeding * Females of childbearing potential who are not willing to use a highly effective method of contraception from the time of informed consent through the protocol-specified duration * Contraindication to fludarabine or cyclophosphamide * History of allergy or hypersensitivity to any trial agent or trial drug components * Life expectancy \< 12 weeks Note: Other protocol defined Inclusion/Exclusion criteria may apply.