A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Standard Regimens in Participants with Relapsed Refractory Multiple Myeloma (DURGA-4)

Condition studied

Relapsed or Refractory Multiple Myeloma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Arm A and B: PFS: defined as the time from the randomisation until the date of documented disease progression according to IMWG 2016 criteria as assessed by BICR or death due to any cause, whichever occurs first., Arm A and B: MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.

Endpoint detail

Arm A and B: OS: defined as time from randomisation until date of death due to any cause, Arm A and B: CRR (CR/sCR rate): defined as the proportion of participants who achieved a best response of CR or better according to IMWG 2016 criteria, as assessed by BICR., Arm A and B: ORR: defined as the proportion of participants who achieved PR or better according to IMWG 2016 criteria, as assessed by BICR., Arm A and B: DoR: defined as the time from first documented confirmed response until date of documented PD per IMWG2016 criteria or death due to any cause, whichever occurs first., Arm A and B: TTR: defined as the time from randomisation until the date of first documented objective response, as assessed per IMWG 2016 criteria., Arm A and B: 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 2016 criteria) at any time after the date of randomisation and before initiation of subsequent therapy., Arm A and B: 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, confirmed minimum 1 year apart without any examination showing MRD positive status in between status assessments., Arm A and B: 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., Arm A and B: TFI: defined as the time from last dose of study intervention to the date of the first dose of subsequent anti-myeloma therapy., Arm A and B: Safety will be evaluated in terms of AEs, vital signs, and clinical laboratory results.