Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07391657

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)

Led by AstraZeneca · Updated on 2026-04-30

508

Participants Needed

111

Research Sites

233 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of multiple myeloma based on IMWG criteria
  • Measurable disease with serum M-protein ≥ 1 g/dL, or urine M-protein ≥ 200 mg/24h, or serum free light chain ≥ 10 mg/dL with abnormal ratio
  • Disease progression by IMWG 2016 criteria during or after most recent therapy; if only 1 prior therapy, progression within 47 months post stem cell transplant or within 42 months if no transplant
  • Received 1 to 3 prior therapies including an IMiD and either a PI or CD38 antibody with at least 2 complete cycles per line unless progression was best response
  • Eligible for at least one standard regimen (DKd, PVd, DPd, or Kd) as determined by investigator
  • ECOG performance status of 0 to 1
  • Adequate lab values: hemoglobin ≥ 8.0 g/dL; neutrophils ≥ 1 x 10^9/L; platelets ≥ 75 x 10^9/L if <50% bone marrow plasma cells or ≥ 50 x 10^9/L if ≥50% plasma cells; lymphocytes ≥ 300/µL; bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN with Gilbert's syndrome); AST and ALT ≤ 3 x ULN; creatinine clearance ≥ 30 mL/min
Not Eligible

You will not qualify if you...

  • Active or prior CNS involvement or meningeal signs of multiple myeloma
  • Primary amyloidosis, active plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS syndrome
  • Primary refractory multiple myeloma with no minimal response to any prior therapy
  • Significant neurological or psychiatric conditions
  • Medical conditions posing unacceptable treatment risks
  • Prior BCMA-targeted therapy
  • Prior CAR-T or CAR-NK therapy targeting any antigen
  • Prior T-cell engager therapy targeting any antigen
  • Prior allogeneic stem cell transplant or autologous transplant within 12 weeks before randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 111 locations

1

Research Site

Gilbert, Arizona, United States, 85234

Not Yet Recruiting

2

Research Site

Phoenix, Arizona, United States, 85054

Not Yet Recruiting

3

Research Site

Tucson, Arizona, United States, 85719

Not Yet Recruiting

4

Research Site

La Jolla, California, United States, 92093

Withdrawn

5

Research Site

Sacramento, California, United States, 95817

Not Yet Recruiting

6

Research Site

Santa Monica, California, United States, 90404

Not Yet Recruiting

7

Research Site

Denver, Colorado, United States, 80218

Not Yet Recruiting

8

Research Site

New Haven, Connecticut, United States, 06510

Not Yet Recruiting

9

Research Site

Washington D.C., District of Columbia, United States, 20007

Not Yet Recruiting

10

Research Site

Coral Gables, Florida, United States, 33156

Not Yet Recruiting

11

Research Site

Atlanta, Georgia, United States, 30322

Not Yet Recruiting

12

Research Site

Chicago, Illinois, United States, 60612

Not Yet Recruiting

13

Research Site

Park Ridge, Illinois, United States, 60068

Withdrawn

14

Research Site

Iowa City, Iowa, United States, 52242

Withdrawn

15

Research Site

Kansas City, Kansas, United States, 66160

Not Yet Recruiting

16

Research Site

Louisville, Kentucky, United States, 40207

Not Yet Recruiting

17

Research Site

Boston, Massachusetts, United States, 02114

Not Yet Recruiting

18

Research Site

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

19

Research Site

Boston, Massachusetts, United States, 02215

Withdrawn

20

Research Site

Detroit, Michigan, United States, 48201

Withdrawn

21

Research Site

Detroit, Michigan, United States, 48202

Withdrawn

22

Research Site

Rochester, Minnesota, United States, 55905

Not Yet Recruiting

23

Research Site

New York, New York, United States, 10016

Withdrawn

24

Research Site

New York, New York, United States, 10029

Not Yet Recruiting

25

Research Site

New York, New York, United States, 10065

Not Yet Recruiting

26

Research Site

Rochester, New York, United States, 14642

Withdrawn

27

Research Site

The Bronx, New York, United States, 10467

Withdrawn

28

Research Site

Chapel Hill, North Carolina, United States, 27514

Not Yet Recruiting

29

Research Site

Charlotte, North Carolina, United States, 28204

Not Yet Recruiting

30

Research Site

Winston-Salem, North Carolina, United States, 27103

Not Yet Recruiting

31

Research Site

Cincinnati, Ohio, United States, 45220

Not Yet Recruiting

32

Research Site

Cleveland, Ohio, United States, 44195

Not Yet Recruiting

33

Research Site

Portland, Oregon, United States, 97239

Not Yet Recruiting

34

Research Site

Charleston, South Carolina, United States, 29425

Withdrawn

35

Research Site

Nashville, Tennessee, United States, 37203

Not Yet Recruiting

36

Research Site

Austin, Texas, United States, 78704

Not Yet Recruiting

37

Research Site

Dallas, Texas, United States, 75235

Not Yet Recruiting

38

Research Site

Houston, Texas, United States, 77030

Not Yet Recruiting

39

Research Site

Salt Lake City, Utah, United States, 84112

Not Yet Recruiting

40

Research Site

Charlottesville, Virginia, United States, 22908

Withdrawn

41

Research Site

Richmond, Virginia, United States, 23298

Withdrawn

42

Research Site

Seattle, Washington, United States, 98104

Not Yet Recruiting

43

Research Site

Madison, Wisconsin, United States, 53792

Not Yet Recruiting

44

Research Site

Milwaukee, Wisconsin, United States, 53226

Not Yet Recruiting

45

Research Site

Camperdown, Australia, 2050

Not Yet Recruiting

46

Research Site

Darlinghurst, Australia, 2010

Not Yet Recruiting

47

Research Site

Fitzroy, Australia, VIC3065

Actively Recruiting

48

Research Site

Liverpool, Australia, 2170

Not Yet Recruiting

49

Research Site

Melbourne, Australia, 3000

Not Yet Recruiting

50

Research Site

Melbourne, Australia, 3004

Not Yet Recruiting

51

Research Site

Murdoch, Australia, WA6150

Not Yet Recruiting

52

Research Site

Salvador, Brazil, 41253-190

Not Yet Recruiting

53

Research Site

São Paulo, Brazil, 01509-900

Not Yet Recruiting

54

Research Site

São Paulo, Brazil, 05652-900

Not Yet Recruiting

55

Research Site

Calgary, Alberta, Canada, T2N 5G2

Not Yet Recruiting

56

Research Site

Vancouver, British Columbia, Canada, V5Z 4E6

Not Yet Recruiting

57

Research Site

Toronto, Ontario, Canada, M5G 2M9

Not Yet Recruiting

58

Research Site

Montreal, Quebec, Canada, H3A 1A1

Not Yet Recruiting

59

Research Site

Lille, France, 59037

Not Yet Recruiting

60

Research Site

Nantes, France, 44093

Not Yet Recruiting

61

Research Site

Paris, France, 75010

Not Yet Recruiting

62

Research Site

Pierre-Bénite, France, 69495

Not Yet Recruiting

63

Research Site

Poitiers, France, 86021

Not Yet Recruiting

64

Research Site

Toulouse, France, 31059

Not Yet Recruiting

65

Research Site

Berlin, Germany, 12200

Not Yet Recruiting

66

Research Site

Dresden, Germany, 01307

Not Yet Recruiting

67

Research Site

Erlangen, Germany, 91054

Not Yet Recruiting

68

Research Site

Essen, Germany, 45147

Not Yet Recruiting

69

Research Site

Freiburg im Breisgau, Germany, 79106

Not Yet Recruiting

70

Research Site

Hamburg, Germany, 20246

Not Yet Recruiting

71

Research Site

Leipzig, Germany, 04103

Not Yet Recruiting

72

Research Site

Mainz, Germany, 55131

Not Yet Recruiting

73

Research Site

Nuremberg, Germany, 90419

Not Yet Recruiting

74

Research Site

Würzburg, Germany, 97080

Not Yet Recruiting

75

Research Site

Bologna, Italy, 40138

Not Yet Recruiting

76

Research Site

Milan, Italy, 20132

Not Yet Recruiting

77

Research Site

Milan, Italy, 20133

Not Yet Recruiting

78

Research Site

Naples, Italy, 80131

Not Yet Recruiting

79

Research Site

Rozzano, Italy, 20089

Not Yet Recruiting

80

Research Site

Torino, Italy, 10126

Not Yet Recruiting

81

Research Site

Bunkyō City, Japan, 113-8431

Not Yet Recruiting

82

Research Site

Kashiwa, Japan, 277-8577

Not Yet Recruiting

83

Research Site

Kyoto, Japan, 602-8566

Not Yet Recruiting

84

Research Site

Nagoya, Japan, 467-8602

Not Yet Recruiting

85

Research Site

Shibuya-ku, Japan, 150-8935

Not Yet Recruiting

86

Research Site

Shinjuku-ku, Japan, 160-8582

Not Yet Recruiting

87

Research Site

Oslo, Norway, 0450

Not Yet Recruiting

88

Research Site

Gdansk, Poland, 80-952

Not Yet Recruiting

89

Research Site

Gliwice, Poland, 44-101

Not Yet Recruiting

90

Research Site

Lublin, Poland, 20-090

Not Yet Recruiting

91

Research Site

Poznan, Poland, 60-569

Not Yet Recruiting

92

Research Site

Warsaw, Poland, 02-776

Not Yet Recruiting

93

Research Site

Wroclaw, Poland, 50-367

Not Yet Recruiting

94

Research Site

Seoul, South Korea, 03080

Not Yet Recruiting

95

Research Site

Seoul, South Korea, 06351

Not Yet Recruiting

96

Research Site

Seoul, South Korea, 06591

Not Yet Recruiting

97

Research Site

Seoul, South Korea, 5505

Not Yet Recruiting

98

Research Site

Barcelona, Spain, 08036

Not Yet Recruiting

99

Research Site

Barcelona, Spain, 8035

Not Yet Recruiting

100

Research Site

Madrid, Spain, 28041

Not Yet Recruiting

101

Research Site

Pamplona, Spain, 31008

Not Yet Recruiting

102

Research Site

Salamanca, Spain, 37007

Not Yet Recruiting

103

Research Site

Santander, Spain, 39008

Not Yet Recruiting

104

Research Site

Valencia, Spain, 46026

Not Yet Recruiting

105

Research Site

Taipei, Taiwan, 10002

Not Yet Recruiting

106

Research Site

Taipei, Taiwan, 106

Not Yet Recruiting

107

Research Site

Taipei, Taiwan, 112

Not Yet Recruiting

108

Research Site

Birmingham, United Kingdom, B9 5SS

Not Yet Recruiting

109

Research Site

Bristol, United Kingdom, BS2 8ED

Not Yet Recruiting

110

Research Site

Glasgow, Scotland, United Kingdom, G12 0YN

Not Yet Recruiting

111

Research Site

London, United Kingdom, SM2 5NG

Not Yet Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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