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Newly Diagnosed Multiple Myeloma (NDMM)GeneticsCancerBiologicalDrugPhase 3

What this study is

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.

What's being tested

  • AZD0120

    Intervention · BIOLOGICAL

    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.

  • Cyclophosphamide

    Intervention · DRUG

    Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.

  • Fludarabine

    Intervention · DRUG

    Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning.

  • Melphalan (part of ASCT)

    Intervention · DRUG

    Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.

  • Lenalidomide

    Intervention · DRUG

    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.

Study details

Official title
A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment With AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Versus Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (TE NDMM) (DURGA-6)
Sponsor
AstraZeneca
Conditions
Newly Diagnosed Multiple Myeloma (NDMM)
Enrolling
750 people
Starts
2026-09-24
Est. completion
2039-11-17
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗