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NCT07764978PHASE3Recruiting

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

AstraZeneca

Start Date

6/26/2026

Completion Date

5/12/2034

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.

Detailed Description

The primary objective is to demonstrate the superiority of IsaVRd or DRd induction followed by a single administration of AZD0120 compared to IsaVRd or DRd induction followed by continuous IsaRd or DRd in terms of progression-free survival (PFS) according to IMWG 2016 criteria, and as assessed by Blinded Independent Central Review (BICR) and miminal residual disease (MRD) negative complete response (CR) rate at 9 months post-randomisation in participants with NDMM who are ineligible to receive ASCT as initial therapy.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

AZD0120

BIOLOGICAL

Daratumumab

DRUG

Dexamethasone

BIOLOGICAL

Isatuximab

DRUG

Lenalidomide

DRUG

Bortezomib

DRUG

Cyclophosphamide

DRUG

Fludarabine

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Conditions

Newly Diagnosed Multiple Myeloma

Locations

Research Site

Gilbert, Arizona 85234

United States

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Phoenix, Arizona 85054

United States

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Tucson, Arizona 85719

United States

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Orange, California 92868

United States

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Santa Monica, California 90404

United States

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Aurora, Colorado 80045

United States

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Denver, Colorado 80218

United States

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New Haven, Connecticut 06510

United States

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Coral Gables, Florida 33156

United States

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Tampa, Florida 33606

United States

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Atlanta, Georgia 30322

United States

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Chicago, Illinois 60607

United States

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Iowa City, Iowa 52242

United States

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Wichita, Kansas 67214

United States

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Louisville, Kentucky 40207

United States

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Baton Rouge, Louisiana 70809

United States

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Baltimore, Maryland 21201

United States

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Detroit, Michigan 48201

United States

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St Louis, Missouri 63110

United States

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East Brunswick, New Jersey 08816

United States

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Albany, New York 12208

United States

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New Hyde Park, New York 11042

United States

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New York, New York 10016

United States

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New York, New York 10029

United States

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New York, New York 10032

United States

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The Bronx, New York 10467

United States

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Chapel Hill, North Carolina 27599

United States

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Charlotte, North Carolina 28203

United States

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Durham, North Carolina 27705

United States

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Winston-Salem, North Carolina 27103

United States

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Winston-Salem, North Carolina 27157

United States

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Cincinnati, Ohio 45236

United States

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Cleveland, Ohio 44195

United States

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Columbus, Ohio 43210

United States

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Montgomery, Ohio 45242

United States

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Portland, Oregon 97239

United States

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Nashville, Tennessee 37203

United States

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Nashville, Tennessee 37219

United States

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Dallas, Texas 75235

United States

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Houston, Texas 77030

United States

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Fairfax, Virginia 22031

United States

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Puyallup, Washington 98373

United States

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Seattle, Washington 98101

United States

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Seattle, Washington 98104

United States

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Milwaukee, Wisconsin 53226

United States

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Concord, 2139

Australia

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Darlinghurst, 2010

Australia

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East Melbourne, 3002

Australia

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Fitzroy, VIC3065

Australia

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Liverpool, 2170

Australia

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Melbourne, 3004

Australia

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Murdoch, 6150

Australia

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Waratah, 2298

Australia

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Salvador, 41253-190

Brazil

Research Site

São Paulo, 01525-001

Brazil

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São Paulo, 05651-901

Brazil

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Calgary, Alberta T2N 5G2

Canada

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Vancouver, British Columbia V5Z 4E6

Canada

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Halifax, Nova Scotia B3H 2Y9

Canada

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Ottawa, Ontario K1H 8L6

Canada

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Montreal, Quebec H1T 2M4

Canada

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Sherbrooke, Quebec J1G 2K7

Canada

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Århus N, 8200

Denmark

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Lille, 59037

France

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Nantes, 44093

France

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Paris, 75010

France

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Poitiers, 86021

France

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Toulouse, 31059

France

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Berlin, 13353

Germany

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Cologne, 50937

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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Kiel, 24105

Germany

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Leipzig, 04103

Germany

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Magdeburg, 39120

Germany

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Mainz, 55131

Germany

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München, 81675

Germany

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Nuremberg, 90419

Germany

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Würzburg, 97080

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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Fukuoka, 812-8582

Japan

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Kyoto, 602-8566

Japan

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Nishinomiya-shi, 663-8501

Japan

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Okayama, 700-8558

Japan

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Sapporo, 060-8648

Japan

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Shibuya-ku, 150-8935

Japan

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Shinjuku-ku, 160-8582

Japan

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Suita-shi, 565-0871

Japan

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Gdansk, 80-952

Poland

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Gliwice, 44-101

Poland

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Kielce, 25-734

Poland

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Lublin, 20-090

Poland

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Poznan, 60-569

Poland

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Wroclaw, 50-367

Poland

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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, 3722

South Korea

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Seoul, 5505

South Korea

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Badalona, 8916

Spain

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Barcelona, 08036

Spain

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Madrid, 28007

Spain

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Madrid, 28041

Spain

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Pamplona, 31008

Spain

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Salamanca, 37007

Spain

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Seville, 41013

Spain

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Valencia, 46026

Spain

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Gothenburg, 413 45

Sweden

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Huddinge, 141 57

Sweden

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Lund, 22242

Sweden

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Taipei, 10002

Taiwan

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Taipei, 106

Taiwan

Research Site

Taipei, 112

Taiwan

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Taoyuan, 33305

Taiwan

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Edinburgh, EH4 2XU

United Kingdom

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London, SE5 9RS

United Kingdom

Research Site

Manchester, M20 4BX

United Kingdom