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NCT Number: NCT07735637

A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6).

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.

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Key information

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Brisbane, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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
  • Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
  • ECOG performance status score of 0 or 1.
  • Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
  • Adequate organ and bone marrow function.

Exclusion criteria

  • 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
  • Participants who required the introduction of an additional agent therapy due to inadequate response.
  • Prior T-cell engager therapy directed at any target.
  • Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
  • Prior any therapy that is targeted to BCMA and CD19.

Treatment and study plan

AZD0120

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

Drug

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

Fludarabine

Drug

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

Melphalan (part of ASCT)

Drug

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

Lenalidomide

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.

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to approximately 13 years.

    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.

  2. Minimal Residual Disease (MRD) negative Complete Response Rate (CRR)

    Time frame: Up to approximately 13 years.

    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 outcomes

  1. Secondary: Overall Survival (OS)

    Time frame: Up to approximately 13 years.

    OS is defined as time from randomisation until date of death due to any cause.

  2. Secondary: Complete Response Rate (CRR)

    Time frame: Up to approximately 13 years.

    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.

  3. Secondary: Overall Response Rate (ORR)

    Time frame: Up to approximately 13 years.

    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.

  4. Secondary: Duration of Response (DoR)

    Time frame: Up to approximately 13 years.

    DoR is defined as the time from first response to progression or death

  5. Other secondary: Time to Response (TTR)

    Time frame: Up to approximately 13 years.

    TTR is defined as the time from randomisation to first response

  6. Safety - Adverse Events

    Time frame: Up to approximately 13 years.

    To evaluate safety in terms of the number of participants experiencing an Adverse Event.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: DURGA-6

Important dates

Study start
2026
Primary completion
2028
Study completion
2039
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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