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).

NCT07735637 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: D8316C00001AZD0120
• Study Type: interventional
• Target: 750
• Locations: 15 countries
• Sites: 65

Brief Summary

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.

Conditions

Newly Diagnosed Multiple Myeloma (NDMM)

Keywords

Multiple Myeloma; NDMM; AZD0120; cell therapy; CAR-T; DURGA-6; BCMA; CD19; transplant eligible

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 13 years.

Secondary Outcomes (6)

• Secondary: Overall Survival (OS)

  Up to approximately 13 years.

• Secondary: Complete Response Rate (CRR)

  Up to approximately 13 years.

• Secondary: Overall Response Rate (ORR)

  Up to approximately 13 years.

• Secondary: Duration of Response (DoR)

  Up to approximately 13 years.

• Other secondary: Time to Response (TTR)

  Up to approximately 13 years.

Study Arms (2)

Arm A: AZD0120

EXPERIMENTAL

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

Biological: AZD0120; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Lenalidomide

Arm B: Autologous Stem Cell Transplant (ASCT)

ACTIVE COMPARATOR

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

Drug: Melphalan (part of ASCT); Drug: Lenalidomide

Interventions

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.

Arm A: AZD0120

Cyclophosphamide DRUG

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

Arm A: AZD0120

Fludarabine DRUG

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

Arm A: AZD0120

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.

Arm B: Autologous Stem Cell Transplant (ASCT)

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.

Arm A: AZD0120; Arm B: Autologous Stem Cell Transplant (ASCT)

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (65)

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30322, United States

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Atlanta, Georgia, 30342, United States

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Chicago, Illinois, 60637, United States

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Detroit, Michigan, 48201, United States

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Rochester, Minnesota, 55905, United States

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Cleveland, Ohio, 44195, United States

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San Antonio, Texas, 78229, United States

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Seattle, Washington, 98104, United States

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Milwaukee, Wisconsin, 53226, United States

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Brisbane, 4102, Australia

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Camperdown, 2050, Australia

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Darlinghurst, 2010, Australia

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Fitzroy, VIC3065, Australia

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Melbourne, 3004, Australia

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Nedlands, 6009, Australia

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Salvador, 41253-190, Brazil

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São Paulo, 01509-900, Brazil

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São Paulo, 05652-900, Brazil

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Calgary, Alberta, T2N 5G2, Canada

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Aarhus, 8200, Denmark

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København Ø, 2100, Denmark

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Odense, 5464, Denmark

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Lille, 59037, France

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Nantes, 44093, France

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Paris, 75012, France

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Paris, 75475, France

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Toulouse, 31059, France

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Berlin, 10117, Germany

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Dresden, 01307, Germany

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Essen, 45122, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 20246, Germany

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Leipzig, 04103, Germany

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München, 81675, Germany

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Oldenburg, 26133, Germany

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Bologna, 40138, Italy

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Milan, 20133, Italy

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Milan, 20141, Italy

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Rome, 00168, Italy

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Rozzano, 20089, Italy

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Torino, 10100, Italy

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Oslo, 0450, Norway

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Gdansk, 80-214, Poland

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Gliwice, 44-100, Poland

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Kielce, 25-734, Poland

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Krakow, 30-688, Poland

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Lublin, 20-090, Poland

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Wroclaw, 50-556, Poland

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Singapore, 119228, Singapore

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Singapore, 169608, Singapore

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Seoul, 03080, South Korea

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Seoul, 06351, South Korea

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Seoul, 06591, South Korea

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Seoul, 5505, South Korea

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Badalona, 08916, Spain

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Barcelona, 08035, Spain

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El Palmar, 30120, Spain

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Madrid, 28034, Spain

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Salamanca, 37007, Spain

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Santander, 39008, Spain

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Seville, 41013, Spain

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Taipei, 106, Taiwan

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Cambridge, CB2 0QQ, United Kingdom

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London, W12 0HS, United Kingdom

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MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cyclophosphamide; fludarabine; Melphalan; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (open label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): October 11, 2028
• Study Completion (Estimated): November 9, 2039
• Last Updated: July 30, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

PL (6); ES (7); SG (2); IT (6); TW (1); AU (6); GB (2); KR (4); FR (5); NO (1); CA (1); DE (8); DK (3); BR (3); US (10)