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Taking peoplePhase 3

AZD0120 CAR-T therapy versus stem cell transplant for newly diagnosed multiple myeloma

Compares AZD0120 with stem cell transplant in adults newly diagnosed with multiple myeloma.

Key facts

Who runs it
AstraZeneca
Where
Berlin, Dresden, Essen, Freiburg im Breisgau, Hamburg, Leipzig, München, and Oldenburg, GermanySee the 8 sitesAlso in 17 other countries, 89 sites
Trial code
Registry title
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).
Status
Recruiting
Phase
Phase 3
People taking part
750 people, planned
Started
24 Sept 2026
Expected to end
17 Nov 2039
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • AZD0120
  • Cyclophosphamide
  • Fludarabine
  • Melphalan (part of ASCT)
  • Lenalidomide
Record updated
21 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed multiple myeloma who have finished induction treatment and can have a stem cell transplant.

Age
18 years or older
Sex
All sexes can join
Disease stage
Newly diagnosed multiple myeloma with measurable disease at diagnosis. The disease must be stable or better after induction treatment.
Earlier treatment
Must have finished 4 to 6 cycles of induction with an approved regimen (anti-CD38+VRd, DVTd, DRd or VRd). Must not have had T-cell engager therapy, CAR-T or CAR-NK cell therapy, or any therapy aimed at BCMA and CD19.
Biomarker or test result
Measurable disease at diagnosis: serum M-protein 1.0 g/dL or more, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) with an abnormal kappa lambda FLC ratio.

Main reasons for not taking part

  • Current or past multiple myeloma in the brain or spinal cord area (CNS), or signs of meningeal involvement
  • Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or POEMS syndrome
  • Significant neurological or psychiatric condition
  • Significant medical condition that puts the person at unacceptable risk from treatment
  • Needed an extra drug added because the response to induction was not good enough

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • ≥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

Who cannot take part

  • Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM
  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 130 years old?

Where in Germany

Also in 17 other countries, 89 sites

  • BerlinHospital not named in the registryNot yet recruiting
  • DresdenHospital not named in the registryNot yet recruiting
  • EssenHospital not named in the registryNot yet recruiting
  • Freiburg im BreisgauHospital not named in the registryNot yet recruiting
  • HamburgHospital not named in the registryNot yet recruiting
  • LeipzigHospital not named in the registryNot yet recruiting
  • MünchenHospital not named in the registryNot yet recruiting
  • OldenburgHospital not named in the registryNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Arm A: AZD0120Treatment being tested

    AZD0120 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy.

    Treatment: AZD0120, Cyclophosphamide, Fludarabine, and Lenalidomide

  • Arm B: Autologous Stem Cell Transplant (ASCT)Existing treatment, for comparison

    ASCT: High-dose melphalan followed by autologous stem cell rescue

    Treatment: Melphalan (part of ASCT) and Lenalidomide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
AZD0120 CAR-T therapy versus stem cell transplant for newly diagnosed multiple myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07735637, who can take part
Record updated
21 October 2026