Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT
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
Interventions
AZD0120
Daratumumab
Dexamethasone
Isatuximab
Lenalidomide
Bortezomib
Cyclophosphamide
Fludarabine
Conditions
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
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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
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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
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Manchester, M20 4BX
United Kingdom