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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).
Sponsor: AstraZeneca
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.
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)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2026-09-24
Completion Date
2039-11-17
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
AZD0120
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
Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.
Fludarabine
Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning.
Melphalan (part of ASCT)
Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.
Lenalidomide
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.
Locations (114)
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Gilbert, Arizona, United States
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Goodyear, Arizona, United States
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Newnan, Georgia, United States
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Chicago, Illinois, United States
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Zion, Illinois, United States
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Lexington, Kentucky, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Great Neck, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Stony Brook, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Charlottesville, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Brisbane, Australia
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Camperdown, Australia
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Darlinghurst, Australia
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East Melbourne, Australia
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Fitzroy, Australia
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Melbourne, Australia
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Nedlands, Australia
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Westmead, Australia
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Salvador, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Calgary, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Beijing, China
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Shanghai, China
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Aarhus, Denmark
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København Ø, Denmark
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Odense, Denmark
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Lille, France
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Nantes, France
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Paris, France
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Paris, France
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Toulouse, France
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Berlin, Germany
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Dresden, Germany
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Essen, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Leipzig, Germany
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München, Germany
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Oldenburg, Germany
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Bologna, Italy
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Milan, Italy
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Milan, Italy
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Rome, Italy
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Rozzano, Italy
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Torino, Italy
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Nagoya, Japan
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Oslo, Norway
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Gdansk, Poland
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Gliwice, Poland
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Kielce, Poland
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Krakow, Poland
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Lublin, Poland
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Wroclaw, Poland
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Riyadh, Saudi Arabia
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Riyadh, Saudi Arabia
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Singapore, Singapore
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Singapore, Singapore
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea