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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).
750 patients around the world
Available in United States, Brazil
AstraZeneca
750Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
To 130 Years
All Gender
Medical requirements
- ≥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.
- 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.
StudyDURGA-6
SponsorAstraZeneca
Study typeInterventional
Conditions
Multiple myeloma
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07735637
