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RECRUITING

NCT07764978

PHASE3

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.

Official title: Phase III Open-Label, Randomised Study of Consolidation With AZD0120 (Dual-Targeting BCMA/CD19 CAR-T) vs Continuous Standard Therapy in NDMM Patients Ineligible for ASCT as Initial Therapy (DURGA-5)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2026-06-26

Completion Date

2034-05-12

Last Updated

2026-08-14

Healthy Volunteers

Conditions

Newly Diagnosed Multiple Myeloma

Interventions

BIOLOGICAL

AZD0120

AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.

BIOLOGICAL

Daratumumab

Induction, optional bridging and continuous therapy.

DRUG

Dexamethasone

Induction, optional bridging and continuous therapy.

BIOLOGICAL

Isatuximab

Induction, optional bridging and continuous therapy.

DRUG

Lenalidomide

Induction, optional bridging and continuous therapy.

DRUG

Bortezomib

Induction therapy.

DRUG

Cyclophosphamide

Lymphodepletion

DRUG

Fludarabine

Lymphodepletion

INCLUSION CRITERIA: 1. Participants must be 18 years or older, at the time of signing the ICF. 2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria. 3. Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio. 4. Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment. 5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator. 6. ECOG performance status Grade of 0 to 2. 7. Participant must have adequate organ and bone marrow function. EXCLUSION CRITERIA: 1. Participant has active or prior CNS or meningeal involvement of MM. 2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome. 3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation. 4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation. 5. Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. 6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status. 7. Participant is positive for any of the following: 1. HIV: Known to be seropositive for HIV (including any history of HIV). 2. Chronic or active hepatitis B. 3. Active hepatitis C: Hepatitis C infection. 4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations. 8. Participant has clinically significant cardiovascular disease. 9. Participant has COPD with an FEV1 \< 50% of predicted normal. 10. Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain.

Locations (124)

Research Site

Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Orange, California, United States

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Santa Monica, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Coral Gables, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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St Louis, Missouri, United States

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East Brunswick, New Jersey, United States

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Albany, New York, United States

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New Hyde Park, 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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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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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Montgomery, Ohio, United States

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Portland, Oregon, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Puyallup, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Concord, Australia

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Darlinghurst, Australia

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East Melbourne, Australia

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Fitzroy, Australia

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Liverpool, Australia

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Melbourne, Australia

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Murdoch, Australia

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Waratah, 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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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Århus N, Denmark

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Lille, France

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Nantes, France

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Paris, France

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Poitiers, France

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Toulouse, France

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Berlin, Germany

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Cologne, 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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Kiel, Germany

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Leipzig, Germany

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Magdeburg, Germany

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Mainz, Germany

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München, Germany

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Nuremberg, Germany

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Würzburg, 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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Fukuoka, Japan

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Kyoto, Japan

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Nishinomiya-shi, Japan

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Okayama, Japan

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Sapporo, Japan

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Shibuya-ku, Japan

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Shinjuku-ku, Japan

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Suita-shi, Japan

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Gdansk, Poland

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Gliwice, Poland

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Kielce, Poland

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Lublin, Poland

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Poznan, Poland

And 24 more locations on ClinicalTrials.gov

Clinical Research Directory

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (124)