A Phase III, Multicentre Study to Evaluate Consolidation Treatment with AZD0120 Compared with ASCT, in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible (DURGA-6). - DURGA-6

Inclusion Criteria

• Inclusion Criteria:
• - ≥18 years of age.
• - Documented diagnosis of NDMM according to IMWG diagnostic criteria.
• - Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC
• ratio)
• - Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
• - Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
• - ECOG performance status score of 0 or 1.
• - Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
• - Adequate organ and bone marrow function.
• Exclusion Criteria:
• - Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
• - Primary amyloidosis, active plasma cell leukaemia (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
• - Significant neurological or psychiatric condition
• - Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
• - Participants who required the introduction of an additional agent therapy due to inadequate response.
• - Prior T-cell engager therapy directed at any target.
• - Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
• - Prior any therapy that is targeted to BCMA and CD19.
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