A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
Who is this study for? Patients with relapsed or refractory multiple myeloma
What treatments are being studied? Dexamethasone+Daratumumab+Iberdomide
Status: Active_not_recruiting
Location: See all (256) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Documented diagnosis of multiple myeloma (MM) and measurable disease.
• Received 1 to 2 prior lines of anti-myeloma therapy.
• Must have documented disease progression during or after their last anti-myeloma regimen.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Locations
United States
Arkansas
Local Institution - 035
Hot Springs
California
Local Institution - 641
Cerritos
Local Institution - 681
Fountain Valley
Local Institution - 047
Los Angeles
Local Institution - 684
Newport
Connecticut
Local Institution - 033
New Haven
Florida
Local Institution - 029
Fort Myers
Local Institution - 693
Ocala
Local Institution - 028
St. Petersburg
Local Institution - 045
Tamarac
Local Institution - 034
West Palm Beach
Local Institution - 685
Weston
Georgia
Local Institution - 018
Atlanta
Illinois
Local Institution - 640
Elk Grove Village
Indiana
Local Institution - 697
Dyer
Kentucky
Local Institution - 040
Louisville
Louisiana
Local Institution - 041
Alexandria
Local Institution - 027
Baton Rouge
Local Institution - 682
Baton Rouge
Massachusetts
Local Institution - 010
Boston
Local Institution - 009
Worcester
Maryland
Local Institution - 698
Baltimore
Local Institution - 014
Bethesda
Local Institution - 688
Columbia
Minnesota
Local Institution - 645
Burnsville
Missouri
Local Institution - 031
Kansas City
Montana
Local Institution - 046
Billings
North Carolina
Local Institution - 039
Durham
New Jersey
Local Institution - 015
Summit
New York
Local Institution - 691
New York
Ohio
Local Institution - 038
Cincinnati
Local Institution - 008
Cleveland
Local Institution - 037
Cleveland
Local Institution - 036
Columbus
Oklahoma
Local Institution - 680
Tulsa
Oregon
Local Institution - 043
Portland
Tennessee
Local Institution - 030
Chattanooga
Local Institution - 021
Nashville
Texas
Local Institution - 687
Austin
Local Institution - 695
Houston
Virginia
Local Institution - 642
Newport News
Local Institution - 643
Roanoke
Wisconsin
Local Institution - 025
Madison
Other Locations
Argentina
Local Institution - 080
Ciudad Autanoma De Buenos Aires
Local Institution - 083
Villa Elisa
Australia
Local Institution - 803
Adelaide
Local Institution - 806
Bedford Park
Local Institution - 813
Birtinya
Local Institution - 804
Camperdown
Local Institution - 802
Clayton
Local Institution - 812
Douglas
Local Institution - 809
East Melbourne
Local Institution - 800
Fitzroy
Local Institution - 808
Garran
Local Institution - 801
Melbourne
Local Institution - 811
Murdoch
Local Institution - 807
West Perth
Austria
Local Institution - 155
Graz
Local Institution - 154
Linz
Local Institution - 153
Salzburg
Local Institution - 156
Sankt Pölten
Local Institution - 150
Vienna
Local Institution - 151
Vienna
Belgium
Local Institution - 172
Bruges
Local Institution - 174
Brussels
Brazil
Local Institution - 051
Barretos
Local Institution - 056
Curitiba
Local Institution - 054
Jaú
Local Institution - 050
Porto Alegre
Local Institution - 058
Porto Alegre
Local Institution - 053
Rio De Janeiro
Local Institution - 052
São Paulo
Local Institution - 055
São Paulo
Local Institution - 057
São Paulo
Canada
Local Institution - 111
Calgary
Local Institution - 103
Edmonton
Local Institution - 101
Halifax
Local Institution - 109
Ottawa
Local Institution - 108
Québec
Local Institution - 104
Saint John
Local Institution - 107
Saskatoon
Local Institution - 110
St. John's
Local Institution - 112
Surrey
China
Local Institution - 138
Beijing
Local Institution - 139
Beijing
Local Institution - 140
Beijing
Local Institution - 126
Changchun
Local Institution - 141
Changsha
Local Institution - 121
Chaoyang District
Local Institution - 135
Guangzhou
Local Institution - 136
Guangzhou
Local Institution - 128
Hangzhou
Local Institution - 120
Hangzhou, Zhejiang
Local Institution - 127
Harbin
Local Institution - 129
Nanchang
Local Institution - 134
Nanjing
Local Institution - 130
Shanghai
Local Institution - 132
Shanghai
Local Institution - 142
Shanghai
Local Institution - 131
Shenyang
Local Institution - 124
Suzhu
Local Institution - 145
Taiyuan
Local Institution - 133
Tianjin
Local Institution - 144
Wenzhou
Local Institution - 137
Wuhan
Local Institution - 125
Xi'an
Local Institution - 143
Xi'an
Local Institution - 123
Zhengzhou
Denmark
Local Institution - 371
Aalborg
Local Institution - 370
Odense
Local Institution - 372
Roskilde
Finland
Local Institution - 230
Helsinki
Local Institution - 232
Oulu
Local Institution - 231
Turku
France
Local Institution - 463
Argenteuil
Local Institution - 462
La Roche-sur-yon
Local Institution - 451
Lille
Local Institution - 458
Nancy
Local Institution - 454
Nantes
Local Institution - 452
Paris
Local Institution - 456
Paris
Local Institution - 464
Pessac
Local Institution - 465
Rouen
Local Institution - 457
Toulouse
Germany
Local Institution - 301
Frankfurt Am Main
Local Institution - 300
Hamburg
Local Institution - 302
Hamburg
Local Institution - 305
Heidelberg
Local Institution - 308
Kiel
Local Institution - 304
Lübeck
Greece
Local Institution - 571
Athens
Local Institution - 573
Pátrai
Local Institution - 574
Pátrai
Local Institution - 570
Thessaloniki
Local Institution - 572
Thessaloniki
India
Local Institution - 930
Bangalore
Local Institution - 934
Ernākulam
Local Institution - 932
Hyderabad
Local Institution - 935
Kolkata
Local Institution - 933
Mumbai
Local Institution - 931
Puducherry
Ireland
Local Institution - 752
Cork
Local Institution - 750
Dublin
Local Institution - 751
Galway
Israel
Local Institution - 874
Afula
Local Institution - 872
Haifa
Local Institution - 871
Jerusalem
Local Institution - 870
Tel Aviv
Local Institution - 873
Tel Litwinsky
Italy
Local Institution - 400
Bologna
Local Institution - 408
Catania
Local Institution - 414
Genova
Local Institution - 404
Milan
Local Institution - 410
Novara
Local Institution - 412
Pavia
Local Institution - 402
Pisa
Local Institution - 405
Reggio Calabria
Local Institution - 401
Roma
Local Institution - 415
Rome
Local Institution - 403
San Giovanni Rotondo Fg
Local Institution - 406
Udine
Japan
Local Institution - 912
Aomori
Local Institution - 916
Chiba
Local Institution - 915
Chuo-shi
Local Institution - 911
Fukuoka
Local Institution - 917
Higashi-ibaraki-gun
Local Institution - 903
Kamogawa
Local Institution - 902
Kyoto
Local Institution - 900
Matsuyama
Local Institution - 901
Nagoya
Local Institution - 910
Nagoya
Local Institution - 920
Nerima-ku
Local Institution - 905
Okayama
Local Institution - 907
Osaka
Local Institution - 908
Ōsaka-sayama
Local Institution - 913
Sapporo
Local Institution - 914
Sendai
Local Institution - 906
Shibuya-ku
Local Institution - 919
Shimotsuga
Local Institution - 918
Shinagawa-ku
Local Institution - 909
Shinagawa-ku, Tokyo
Local Institution - 904
Toyohashi
Mexico
Local Institution - 183
Guadalajara
Netherlands
Local Institution - 354
Amsterdam
Local Institution - 351
Dordrecht
Local Institution - 352
The Hague
Norway
Local Institution - 202
Bergen
Local Institution - 200
Oslo
Local Institution - 201
Trondheim
Poland
Local Institution - 631
Bialystok
Local Institution - 633
Krakow
Local Institution - 635
Nowy Sącz
Local Institution - 634
Poznan
Local Institution - 636
Wałbrzych
Local Institution - 630
Warsaw
Portugal
Local Institution - 545
Coimbra
Local Institution - 543
Lisbon
Local Institution - 544
Lisbon
Local Institution - 540
Porto
Local Institution - 541
Porto
Republic of Korea
Local Institution - 974
Daegu
Local Institution - 973
Gyeonggi-do
Local Institution - 975
Hwasun-gun
Local Institution - 970
Seoul
Local Institution - 971
Seoul
Local Institution - 972
Seoul
Local Institution - 976
Seoul
Local Institution - 977
Seoul
Spain
Local Institution - 502
Barcelona
Local Institution - 505
Barcelona
Local Institution - 511
Barcelona
Local Institution - 501
Cáceres
Local Institution - 509
Córdoba
Local Institution - 504
Madrid
Local Institution - 510
Madrid
Local Institution - 513
Madrid
Local Institution - 516
Madrid
Local Institution - 503
Málaga
Local Institution - 508
Murcia
Local Institution - 506
Oviedo
Local Institution - 514
Pamplona
Local Institution - 515
Salamanca
Local Institution - 500
Santiago De Compostela
Local Institution - 512
Valencia
Local Institution - 507
Zaragoza
Sweden
Local Institution - 272
Borås
Local Institution - 271
Helsingborg
Switzerland
Local Institution - 851
Chur
Local Institution - 850
Sankt Gallen
Taiwan
Local Institution - 955
Niao-sung Hsiang Kaohsiung County
Local Institution - 952
Taichung
Local Institution - 954
Taichung
Local Institution - 951
Tainan, Taiana
Local Institution - 950
Taipei
Local Institution - 956
Taipei, Zhongzheng Dist.
Local Institution - 953
Taoyuan
Turkey
Local Institution - 770
Ankara
Local Institution - 771
Balçova
Local Institution - 775
Bornova
Local Institution - 772
Gaziantep
Local Institution - 778
Kavaklıdere
Local Institution - 774
Kayseri
Local Institution - 777
Pendik
Local Institution - 773
Samsun
Local Institution - 776
Yenimahalle
United Kingdom
Local Institution - 705
Belfast Northern Ireland
Local Institution - 700
Birmingham
Local Institution - 707
Canterbury Kent
Local Institution - 704
Lancashire Blackpool
Local Institution - 701
London
Local Institution - 709
London
Local Institution - 702
Nottingham
Local Institution - 706
Oxford
Local Institution - 711
Portsmouth
Local Institution - 713
Sutton
Local Institution - 708
Wolverhampton
Time Frame
Start Date: 2022-06-23
Completion Date: 2032-06-25
Participants
Target number of participants: 864
Treatments
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
Active_comparator: Daratumumab in combination with dexamethasone and bortezomib
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
Related Therapeutic Areas
Sponsors
Leads: Celgene