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
Parallel
AZD0120
Biological/VaccineArm A: AZD0120 - autologous BCMA/CD19 dual-targeting CAR-T cells. Participants will receive lymphodepletion conditioning (cyclophosphamide and fludarabine) followed by AZD0120 CAR-T cell infusion.
Cyclophosphamide
DrugArm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.
Fludarabine
DrugArm A: Fludarabine will be given intravenously as lymphodepletion conditioning.
Melphalan (part of ASCT)
DrugArm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.
Lenalidomide
DrugArm A and Arm B: Lenalidomide maintenance treatment will be started in both Arm A and Arm B after AZD0120 therapy or ASCT, respectively. Lenalidomide maintenance on study will be continued up to 2 years.
Progression-Free Survival (PFS)
PFS is defined as time from randomisation until progression as assessed by Blinded Independent Central Review, or death due to any cause, whichever occurs first.
Minimal Residual Disease (MRD) negative Complete Response Rate (CRR)
MRD negative CRR is defined as the proportion of participants with a MRD negative status and who have a response of CR or a stringent CR.
Secondary: Overall Survival (OS)
OS is defined as time from randomisation until date of death due to any cause.
Secondary: Complete Response Rate (CRR)
CRR (CR or stringent CR rate) is defined as the proportion of participants who achieved CR or better and as assessed by Blinded Independent Central Review.
Secondary: Overall Response Rate (ORR)
ORR is defined as the proportion of participants with a response (complete, partial or very good partial response) as assessed by Blinded Independent Central Review.
Secondary: Duration of Response (DoR)
DoR is defined as the time from first response to progression or death
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