A Phase III Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5).

Newly Diagnosed Multiple Myeloma

1) PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first., 2) MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) as assessed by BICR at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.

• CRR (CR/sCR rate): defined as the proportion of participants who achieved CR or better according to IMWG 2016 criteria, as assessed by BICR., • OS: defined as time from randomisation until date of death due to any cause., • ORR: defined as the proportion of participants who achieved PR or better according to IMWG 2016 criteria., • DoR: defined as the time from first documented confirmed response (PR or better) until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first., • TTR: defined as the time from randomisation until the date of first documented objective response (PR or better), as assessed per IMWG 2016 criteria., • MRD negative CR rate: defined as the proportion of participants who have MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) at any time after the date of randomisation and before initiation of subsequent therapy., • Rate of sustained MRD negative CR: defined as the proportion of participants who have achieved MRD negative status (at threshold of 10-5), and have a response of CR or sCR, confirmed at a minimum 1 year apart without any examination showing MRD positive status or PD in between., • PFS2: defined as the time from randomisation to progression on next line of therapy, as assessed by Investigator, or death due to any cause, whichever occurs first., • TFI: defined as the time from last dose of study intervention to the date of the first dose of subsequent anti-myeloma therapy., • Safety will be evaluated in terms of AEs, vital signs, and clinical laboratory results., • Quantification of circulating CAR-T+ cell levels by measuring CAR transgene in peripheral blood., • CK parameters of AZD0120, including but not limited to Tmax, Cmax, AUClast, AUC0-3M, AUC0-28d, Tlast, and Clast as data allows., • Prevalence and incidence of ADAs against AZD0120, and the impact on CK, efficacy, and safety, as data allow., • Change from baseline in: EORTC QLQ-C30, EORTC IL469, EORTC IL-TFI, PGI-TT, PGIS, EQ-5D-5L

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