This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.
Age ≥ 18 years
Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
Serum M-protein level ≥ 1 g/dL
Urine M-protein level ≥ 200 mg/24h
Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
Significant neurological or psychiatric condition
Parallel
AZD0120
Biological/VaccineCAR-T Cells
Daratumumab
DrugDaratumumab
Carfilzomib
DrugCarfilzomib
Dexamethasone
DrugDexamethasone
Bortezomib
DrugBortezomib
Pomalidomide
DrugPomalidomides
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.
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.
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM.
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 IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.
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