A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment with AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible (TE NDMM) (DURGA-6)

Condition studied

Newly Diagnosed Multiple Myeloma

Investigational medicinal product(s)

Every trial of AZD0120, Melphalan and Lenalidomide across our registers →

Eligibility

Primary endpoint

PFS: defined as time from randomisation until progression per IMWG criteria 2016, as assessed by BICR, or death due to any cause, whichever occurs first., 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 criteria 2016, assessed by BICR) at 9 months (± 3 months) from randomisation.

Endpoint detail

Key Secondary: • OS: defined as time from randomisation until date of death due to any cause., Key Secondary: • CRR (CR/sCR rate): defined as the proportion of participants who achieved CR or better according to IMWG criteria 2016, as assessed by BICR., Other Secondary: • ORR: defined as the proportion of participants who achieved PR or better according to IMWG criteria 2016,assessed by BICR., Other Secondary: • DoR: defined as the time from first documented confirmed response (PR or better) until date of documented progression of disease per IMWG criteria 2016, assessed by BICR, or death due to any cause, whichever occurs first., Other Secondary: • DoCR: defined as the time from first documented complete response until date of documented progression of disease per IMWG criteria 2016, assessed by BICR, or death due to any cause, whichever occurs first., Other Secondary: • TTR: defined as the time from randomisation until the date of first documented objective response (PR or better), as assessed by BICR per IMWG criteria 2016., Other Secondary: • MRD negative CR rate: defined as the proportion of participants who have MRD negative status and have a response of CR or sCR (according to the IMWG criteria 2016, assessed by BICR) at any time after the date of randomisation., Other Secondary: • Rate of sustained MRD negative CR: defined as the proportion of participants who have achieved MRD negative status, and have a response of CR or sCR (according to the IMWG criteria 2016, assessed by BICR), confirmed at a minimum 1 year apart without any examination showing MRD positive status or PD in between., Other Secondary: • PFS-2: defined as the time from randomisation to progression on next line of therapy, as assessed by Investigator or death due to any cause., Other Secondary: • TFI: defined as the time from last dose of study intervention to the date of the first dose of subsequent therapy., Safety: Safety will be evaluated in terms of AEs, vital signs, and clinical laboratory results.