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).
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.
You may not be if
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.
Clareo Health | 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).