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NCT07391657PHASE3Recruiting

A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)

AstraZeneca

Start Date

2/23/2026

Completion Date

7/29/2030

Summary

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age ≥ 18 years * Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria * Documented evidence of measurable disease: 1. Serum M-protein level ≥ 1 g/dL 2. Urine M-protein level ≥ 200 mg/24h 3. Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy * Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy * Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator. * ECOG performance status score of 0 to 1 * Adequate hematology and chemistry laboratory values: 1. Haemoglobin ≥ 8.0 g/dL 2. Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3) 3. Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with \< 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells 4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L) 5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute Exclusion Criteria: * Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM. * Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome. * Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy) * Significant neurological or psychiatric condition * Significant medical condition that places the participant at an unacceptable risk for treatment-related complications * Previously received any prior BCMA-targeted treatment * Previously received CAR-T or CAR-NK therapy directed at any target * Previously received T-cell engager therapy directed at any target * Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization

Interventions

BIOLOGICAL

AZD0120

DRUG

Daratumumab

DRUG

Carfilzomib

DRUG

Dexamethasone

DRUG

Bortezomib

DRUG

Pomalidomide

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Conditions

Relapsed Refractory Multiple Myeloma

Locations

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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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La Jolla, California 92093

United States

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Sacramento, California 95817

United States

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Santa Monica, California 90404

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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Washington D.C., District of Columbia 20007

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 60612

United States

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Park Ridge, Illinois 60068

United States

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Iowa City, Iowa 52242

United States

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Kansas City, Kansas 66160

United States

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Louisville, Kentucky 40207

United States

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Boston, Massachusetts 02114

United States

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Boston, Massachusetts 02215

United States

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Boston, Massachusetts 02215

United States

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Detroit, Michigan 48201

United States

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Detroit, Michigan 48202

United States

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Rochester, Minnesota 55905

United States

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Albany, New York 12208

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 10065

United States

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New York, New York 10065

United States

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Rochester, New York 14642

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The Bronx, New York 10467

United States

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Chapel Hill, North Carolina 27514

United States

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Charlotte, North Carolina 28204

United States

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Winston-Salem, North Carolina 27157

United States

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Cincinnati, Ohio 45220

United States

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Cleveland, Ohio 44195

United States

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Portland, Oregon 97239

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Charleston, South Carolina 29425

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Nashville, Tennessee 37203

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Austin, Texas 78704

United States

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Dallas, Texas 75235

United States

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Houston, Texas 77030

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Salt Lake City, Utah 84112

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Charlottesville, Virginia 22908

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Gainesville, Virginia 20155

United States

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Richmond, Virginia 23298

United States

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Seattle, Washington 98104

United States

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Madison, Wisconsin 53792

United States

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Milwaukee, Wisconsin 53226

United States

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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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Liverpool, 2170

Australia

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Melbourne, 3000

Australia

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Melbourne, 3004

Australia

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Murdoch, WA6150

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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Vancouver, British Columbia V5Z 4E6

Canada

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Toronto, Ontario M5G 2M9

Canada

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Montreal, Quebec H3A 1A1

Canada

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Beijing, 100024

China

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Beijing, 100044

China

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Changchun, 130021

China

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Changsha, 410008

China

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Changsha, 410013

China

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Chongqing, 400030

China

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Guangzhou, 510000

China

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Guangzhou, 510060

China

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Hefei, 230601

China

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Nanchang, 330000

China

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Nanchang, 330006

China

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Nanjing, 210000

China

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Ningbo, 315040

China

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Shanghai, 200025

China

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Shanghai, 200065

China

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Shanghai, 201210

China

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Shenzhen, 518039

China

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Tianjin, 300020

China

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Wenzhou, 325000

China

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Xi'an, 710004

China

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Xi'an, 710061

China

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Zhengzhou, 450000

China

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Zhengzhou, 450008

China

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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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Pierre-Bénite, 69495

France

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Poitiers, 86021

France

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Toulouse, 31059

France

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Berlin, 12200

Germany

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Dresden, 01307

Germany

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Erlangen, 91054

Germany

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Essen, 45147

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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Mainz, 55131

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, 20132

Italy

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Milan, 20133

Italy

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Naples, 80131

Italy

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Rozzano, 20089

Italy

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Torino, 10126

Italy

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Bunkyō City, 113-8431

Japan

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Kashiwa, 277-8577

Japan

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Kyoto, 602-8566

Japan

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Nagoya, 467-8602

Japan

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Shibuya-ku, 150-8935

Japan

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Shinjuku-ku, 160-8582

Japan

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Oslo, 0450

Norway

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Gdansk, 80-952

Poland

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Gliwice, 44-101

Poland

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Lublin, 20-090

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Poznan, 60-569

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Warsaw, 02-776

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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, 5505

South Korea

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Barcelona, 08036

Spain

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Barcelona, 8035

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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Santander, 39008

Spain

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Valencia, 46026

Spain

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Taipei, 10002

Taiwan

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Taipei, 106

Taiwan

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Taipei, 112

Taiwan

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Birmingham, B9 5SS

United Kingdom

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Bristol, BS2 8ED

United Kingdom

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Glasgow, Scotland, G12 0YN

United Kingdom

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London, SM2 5NG

United Kingdom