The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete response (CR) rate at 9 months as assessed by Blinded Independent Central Review (BICR), in participants with TE NDMM.
Study details include:
* The study duration is estimated to be up to 13 years from the date the first participant is randomised. * For participants in Arm A (AZD0120), the total duration of participant follow-up will be 15 years (including a Long Term Follow-up study) after the last participant has received the AZD0120 infusion. * The treatment duration will be:- Arm A (AZD0120): lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment.
* Arm B (ASCT): conditioning therapy over 24 to 48 hours, ASCT, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment.
Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.
≥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
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