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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
Arm 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.
Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.
Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning.
Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.
Arm 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.
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Detroit, Michigan, United States
Research Site
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.
Time frame: Up to approximately 13 years.
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.
Time frame: Up to approximately 13 years.
Secondary: Overall Survival (OS)
OS is defined as time from randomisation until date of death due to any cause.
Time frame: Up to approximately 13 years.
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.
Time frame: Up to approximately 13 years.
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.
Time frame: Up to approximately 13 years.
Secondary: Duration of Response (DoR)
DoR is defined as the time from first response to progression or death
Time frame: Up to approximately 13 years.
Other secondary: Time to Response (TTR)
TTR is defined as the time from randomisation to first response
Time frame: Up to approximately 13 years.
Safety - Adverse Events
To evaluate safety in terms of the number of participants experiencing an Adverse Event.
Time frame: Up to approximately 13 years.
AstraZeneca Clinical Study Information Center
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