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.
Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.
Inclusion Criteria:
Exclusion Criteria:
information.center@astrazeneca.com
None (open label)
AZD0120 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy.
ASCT: High-dose melphalan followed by autologous stem cell rescue
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