- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06232707
A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ALUMMINATE)
A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Contact Backup
- Name: First line of the email MUST contain NCT # and Site #.
Study Locations
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Buenos Aires
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Florencio Varela, Buenos Aires, Argentina, 1888
- Local Institution - 0222
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Contact:
- Site 0222
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La Plata, Buenos Aires, Argentina, 1900
- Local Institution - 0001
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Contact:
- Site 0001
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Pilar, Buenos Aires, Argentina, 1629
- Local Institution - 0262
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Contact:
- Site 0262
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Ciudad Autónoma De Buenos Aires
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Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1118AAT
- Local Institution - 0002
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Contact:
- Site 0002
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New South Wales
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Liverpool, New South Wales, Australia, 2170
- Local Institution - 0260
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Contact:
- Site 0260
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Macquarie University, New South Wales, Australia, 2109
- Local Institution - 0246
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Contact:
- Site 0246
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Waratah, New South Wales, Australia, 2298
- Local Institution - 0022
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Contact:
- Site 0022
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Queensland
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Brisbane, Queensland, Australia, 4120
- Local Institution - 0397
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Contact:
- Site 0397
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Victoria
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Box Hill, Victoria, Australia, 3128
- Local Institution - 0021
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Contact:
- Site 0021
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Clayton, Victoria, Australia, 3168
- Local Institution - 0019
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Contact:
- Site 0019
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Melbourne, Victoria, Australia, 3004
- Local Institution - 0018
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Contact:
- Site 0018
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Melbourne, Victoria, Australia, 3065
- Local Institution - 0003
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Contact:
- Site 0003
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Salzburg, Austria, 5020
- Local Institution - 0334
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Contact:
- Site 0334
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Wien, Austria, 1090
- Local Institution - 0332
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Contact:
- Site 0332
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Niederösterreich
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St. Polten, Niederösterreich, Austria, 3100
- Local Institution - 0333
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Contact:
- Site 0333
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Tirol
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Innsbruck, Tirol, Austria, 6020
- Local Institution - 0337
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Contact:
- Site 0337
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Antwerpen
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Brasschaat, Antwerpen, Belgium, 2930
- Local Institution - 0284
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Contact:
- Site 0284
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Liège
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Verviers, Liège, Belgium, 4800
- Local Institution - 0280
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Contact:
- Site 0280
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Namur
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Yvoir, Namur, Belgium, 5530
- Local Institution - 0279
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Contact:
- Site 0279
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- Local Institution - 0286
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Contact:
- Site 0286
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Rio de Janeiro, Brazil, 22250-905
- Local Institution - 0291
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Contact:
- Site 0291
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São Paulo, Brazil, 05652-900
- Local Institution - 0211
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Contact:
- Site 0211
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30110-022
- Local Institution - 0274
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Contact:
- Site 0274
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Rio Grande Do Norte
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Natal, Rio Grande Do Norte, Brazil, 59025050
- Local Institution - 0351
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Contact:
- Site 0351
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São Paulo
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Sao Paulo, São Paulo, Brazil, 01509-010
- Local Institution - 0369
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Contact:
- Site 0369
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Local Institution - 0417
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Contact:
- Site 0417
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Edmonton, Alberta, Canada, T6G1Z2
- Local Institution - 0423
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Contact:
- Site 0423
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Ontario
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London, Ontario, Canada, N6A 5W9
- Local Institution - 0402
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Contact:
- Site 0402
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Toronto, Ontario, Canada, M5G 2M9
- Local Institution - 0395
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Contact:
- Site 0395
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Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- Local Institution - 0031
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Contact:
- Site 0031
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Montréal, Quebec, Canada, H2X 1P1
- Local Institution - 0098
-
Contact:
- Site 0098
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Metropolitana DE Santiago
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Santiago, Metropolitana DE Santiago, Chile, 7580206
- Local Institution - 0027
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Contact:
- Site 0027
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Región Metropolitana De Santiago
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Santiago, Región Metropolitana De Santiago, Chile, 7500921
- Local Institution - 0030
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Contact:
- Site 0030
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Santiago, Región Metropolitana De Santiago, Chile, 7650568
- Local Institution - 0029
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Contact:
- Site 0029
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Santiago, Región Metropolitana De Santiago, Chile, 7620002
- Local Institution - 0026
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Contact:
- Site 0026
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Qingdao, China, 266011
- Local Institution - 0367
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Contact:
- Site 0367
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Beijing
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Beijing, Beijing, China
- Local Institution - 0413
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Contact:
- Site 0413
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Beijing, Beijing, China, 100020
- Local Institution - 0230
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Contact:
- Site 0230
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Beijing, Beijing, China, 100034
- Local Institution - 0040
-
Contact:
- Site 0040
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Changping, Beijing, China, 102200
- Local Institution - 0366
-
Contact:
- Site 0366
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Chongqing
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Chongqing, Chongqing, China, 400016
- Local Institution - 0057
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Contact:
- Site 0057
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Local Institution - 0080
-
Contact:
- Site 0080
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Guangzhou, Guangdong, China, 510060
- Local Institution - 0066
-
Contact:
- Site 0066
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Guangzhou, Guangdong, China, 510515
- Local Institution - 0226
-
Contact:
- Site 0226
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Shenzhen, Guangdong, China, 518036
- Local Institution - 0368
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Contact:
- Site 0368
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Hebei
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Baoding, Hebei, China, 071030
- Local Institution - 0365
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Contact:
- Site 0365
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Shijiazhuang, Hebei, China, 050051
- Local Institution - 0082
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Contact:
- Site 0082
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Henan
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Zhengzhou, Henan, China, 450008
- Local Institution - 0041
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Contact:
- Site 0041
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Hubei
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Wuhan, Hubei, China, 430030
- Local Institution - 0075
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Contact:
- Site 0075
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Hunan
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Changsha, Hunan, China, 410011
- Local Institution - 0062
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Contact:
- Site 0062
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Changsha, Hunan, China, 410013
- Local Institution - 0053
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Contact:
- Site 0053
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Jiangsu
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Nanjing, Jiangsu, China, 210000
- Local Institution - 0055
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Contact:
- Site 0055
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Suzhou, Jiangsu, China, 215006
- Local Institution - 0067
-
Contact:
- Site 0067
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Xuzhou, Jiangsu, China, 221006
- Local Institution - 0377
-
Contact:
- Site 0377
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Liaoning
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Shenyang, Liaoning, China, 110004
- Local Institution - 0044
-
Contact:
- Site 0044
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Shaanxi
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Xi'An, Shaanxi, China, 710004
- Local Institution - 0072
-
Contact:
- Site 0072
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Shandong
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Jinan, Shandong, China, 250014
- Local Institution - 0077
-
Contact:
- Site 0077
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Jinan, Shandong, China, 250117
- Local Institution - 0083
-
Contact:
- Site 0083
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Shanghai
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Shanghai, Shanghai, China, 200032
- Local Institution - 0273
-
Contact:
- Site 0273
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Shanghai, Shanghai, China, 200081
- Local Institution - 0421
-
Contact:
- Site 0421
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Shanxi
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Taiyuan, Shanxi, China, 030000
- Local Institution - 0245
-
Contact:
- Site 0245
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Tianjin
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Tianjin, Tianjin, China, 300052
- Local Institution - 0056
-
Contact:
- Site 0056
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Tianjin, Tianjin, China, 300308
- Local Institution - 0422
-
Contact:
- Site 0422
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Local Institution - 0070
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Contact:
- Site 0070
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Hangzhou, Zhejiang, China, 310003
- Local Institution - 0203
-
Contact:
- Site 0203
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-
-
-
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Praha 2, Czechia, 12808
- Local Institution - 0012
-
Contact:
- Site 0012
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Brno-město
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Brno, Brno-město, Czechia, 625 00
- Local Institution - 0013
-
Contact:
- Site 0013
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Olomoucký Kraj
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Olomouc, Olomoucký Kraj, Czechia, 779 00
- Local Institution - 0247
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Contact:
- Site 0247
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-
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Haute-Garonne
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Toulouse, Haute-Garonne, France, 31100
- Local Institution - 0118
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Contact:
- Site 0118
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Languedoc-Roussillon
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Montpellier, Languedoc-Roussillon, France, 34295
- Local Institution - 0225
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Contact:
- Site 0225
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Lorraine
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Vandoeuvre lès Nancy, Lorraine, France, 54511
- Local Institution - 0224
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Contact:
- Site 0224
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Nord
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Lille, Nord, France, 59000
- Local Institution - 0084
-
Contact:
- Site 0084
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Pays-de-la-Loire
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Nantes, Pays-de-la-Loire, France, 44000
- Local Institution - 0085
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Contact:
- Site 0085
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Rhône
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Pierre-Bénite, Rhône, France, 69310
- Local Institution - 0192
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Contact:
- Site 0192
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Hamburg, Germany, 22763
- Local Institution - 0339
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Contact:
- Site 0339
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69120
- Local Institution - 0331
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Contact:
- Site 0331
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Tübingen, Baden-Württemberg, Germany, 72076
- Local Institution - 0330
-
Contact:
- Site 0330
-
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Sachsen
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Dresden, Sachsen, Germany, 01307
- Local Institution - 0335
-
Contact:
- Site 0335
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Leipzig, Sachsen, Germany, 04103
- Local Institution - 0329
-
Contact:
- Site 0329
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-
-
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Attikí
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Athens, Attikí, Greece, 115 28
- Local Institution - 0004
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Contact:
- Site 0004
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Chaidari, Attikí, Greece, 12462
- Local Institution - 0136
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Contact:
- Site 0136
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-
-
-
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Budapest, Hungary, 1088
- Local Institution - 0104
-
Contact:
- Site 0104
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Budapest, Hungary, 1097
- Local Institution - 0105
-
Contact:
- Site 0105
-
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Szabolcs-Szatmár-Bereg
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Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
- Local Institution - 0103
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Contact:
- Site 0103
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Vas
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Szombathely, Vas, Hungary, 9700
- Local Institution - 0108
-
Contact:
- Site 0108
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-
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Andhra Pradesh
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Visakhapatnam, Andhra Pradesh, India, 530040
- Local Institution - 0370
-
Contact:
- Site 0370
-
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Haryana
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Gurugram, Haryana, India, 122011
- Local Institution - 0362
-
Contact:
- Site 0362
-
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Karnataka
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Bangalore, Karnataka, India, 560092
- Local Institution - 0403
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Contact:
- Site 0403
-
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226014
- Local Institution - 0399
-
Contact:
- Site 0399
-
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West Bengal
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Kolkata, West Bengal, India, 700094
- Local Institution - 0398
-
Contact:
- Site 0398
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-
-
-
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Cork, Ireland, T12 E8YV
- Local Institution - 0281
-
Contact:
- Site 0281
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Dublin, Ireland, D04 N2E0
- Local Institution - 0371
-
Contact:
- Site 0371
-
Dublin, Ireland, D08 E9P6
- Local Institution - 0285
-
Contact:
- Site 0285
-
Limerick, Ireland, V94 F858
- Local Institution - 0269
-
Contact:
- Site 0269
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-
-
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italy, 47014
- Local Institution - 0096
-
Contact:
- Site 0096
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Milano
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Legnano, Milano, Italy, 20025
- Local Institution - 0294
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Contact:
- Site 0294
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Milan, Milano, Italy, 20162
- Local Institution - 0265
-
Contact:
- Site 0265
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Sicilia
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Palermo, Sicilia, Italy, 90127
- Local Institution - 0410
-
Contact:
- Site 0410
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-
-
-
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Chiba, Japan, 260-8677
- Local Institution - 0383
-
Contact:
- Site 0383
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Kumamoto, Japan, 860-8556
- Local Institution - 0391
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Contact:
- Site 0391
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Kyoto, Japan, 602-8566
- Local Institution - 0389
-
Contact:
- Site 0389
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Okayama, Japan, 701-1192
- Local Institution - 0388
-
Contact:
- Site 0388
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Tokyo, Japan, 150-8935
- Local Institution - 0384
-
Contact:
- Site 0384
-
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Aichi
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Anjo, Aichi, Japan, 446-8602
- Local Institution - 0409
-
Contact:
- Site 0409
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Nagoya, Aichi, Japan, 467-8602
- Local Institution - 0387
-
Contact:
- Site 0387
-
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Chiba
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Kamogawa, Chiba, Japan, 296-0041
- Local Institution - 0407
-
Contact:
- Site 0407
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Kashiwa, Chiba, Japan, 277-8577
- Local Institution - 0385
-
Contact:
- Site 0385
-
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Kanagawa
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Isehara, Kanagawa, Japan, 259-1193
- Local Institution - 0386
-
Contact:
- Site 0386
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Osaka
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Osaka-sayama, Osaka, Japan, 589-8511
- Local Institution - 0390
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Contact:
- Site 0390
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Tochigi
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Shimotsuga, Tochigi, Japan, 321-0293
- Local Institution - 0381
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Contact:
- Site 0381
-
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Tokyo
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Koto, Tokyo, Japan, 135-8550
- Local Institution - 0382
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Contact:
- Site 0382
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-
-
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Kyǒnggi-do
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Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
- Local Institution - 0240
-
Contact:
- Site 0240
-
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Pusan-Kwangyǒkshi
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Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49201
- Local Institution - 0221
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Contact:
- Site 0221
-
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Seoul-teukbyeolsi [Seoul]
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Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
- Local Institution - 0036
-
Contact:
- Site 0036
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Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
- Local Institution - 0239
-
Contact:
- Site 0239
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Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
- Local Institution - 0034
-
Contact:
- Site 0034
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Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06591
- Local Institution - 0035
-
Contact:
- Site 0035
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-
-
-
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Oslo, Norway, 0450
- Local Institution - 0193
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Contact:
- Site 0193
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Akershus
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Løenskog, Akershus, Norway, 1474
- Local Institution - 0137
-
Contact:
- Site 0137
-
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Hordaland
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Bergen, Hordaland, Norway, 5021
- Local Institution - 0115
-
Contact:
- Site 0115
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-
-
-
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Lisboa, Portugal, 1500-650
- Local Institution - 0255
-
Contact:
- Site 0255
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Lisboa
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Lisbon, Lisboa, Portugal, 1099-023
- Local Institution - 0242
-
Contact:
- Site 0242
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Lisbon, Lisboa, Portugal, 1649-035
- Local Institution - 0415
-
Contact:
- Site 0415
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-
-
-
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Brasov, Romania, 500052
- Local Institution - 0171
-
Contact:
- Site 0171
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București, Romania, 050098
- Local Institution - 0414
-
Contact:
- Site 0414
-
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București
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Bucuresti, București, Romania, 022328
- Local Institution - 0169
-
Contact:
- Site 0169
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-
-
-
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Jerez de la Frontera, Spain, 11407
- Local Institution - 0202
-
Contact:
- Site 0202
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Salamanca, Spain, 37007
- Local Institution - 0006
-
Contact:
- Site 0006
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Santiago de Compostela, Spain, 15706
- Local Institution - 0007
-
Contact:
- Site 0007
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València, Spain, 46026
- Local Institution - 0009
-
Contact:
- Site 0009
-
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Barcelona [Barcelona]
-
Badalona, Barcelona [Barcelona], Spain, 08916
- Local Institution - 0011
-
Contact:
- Site 0011
-
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Murcia, Región De
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El Palmar, Murcia, Murcia, Región De, Spain, 30120
- Local Institution - 0234
-
Contact:
- Site 0234
-
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Navarra
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Pamplona, Navarra, Spain, 31008
- Local Institution - 0008
-
Contact:
- Site 0008
-
-
-
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Västra Götalands Län [se-14]
-
Borås, Västra Götalands Län [se-14], Sweden, 501 82
- Local Institution - 0114
-
Contact:
- Site 0114
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Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
- Local Institution - 0111
-
Contact:
- Site 0111
-
-
-
-
-
Zürich, Switzerland, 8063
- Local Institution - 0338
-
Contact:
- Site 0338
-
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Berne
-
Bern, Berne, Switzerland, 3010
- Local Institution - 0336
-
Contact:
- Site 0336
-
-
Sankt Gallen
-
st.Gallen, Sankt Gallen, Switzerland, 9007
- Local Institution - 0411
-
Contact:
- Site 0411
-
-
-
-
-
Ankara, Turkey, 06200
- Local Institution - 0375
-
Contact:
- Site 0375
-
Kayseri, Turkey
- Local Institution - 0187
-
Contact:
- Site 0187
-
İzmir, Turkey, 35100
- Local Institution - 0188
-
Contact:
- Site 0188
-
-
İstanbul
-
Stanbul, İstanbul, Turkey, 34214
- Local Institution - 0325
-
Contact:
- Site 0325
-
-
-
-
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Cardiff, United Kingdom, CF14 4XW
- Local Institution - 0350
-
Contact:
- Site 0350
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Derby, United Kingdom, DE22 3NE
- Local Institution - 0344
-
Contact:
- Site 0344
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Manchester, United Kingdom, M20 4BX
- Local Institution - 0343
-
Contact:
- Site 0343
-
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Hampshire
-
Southampton, Hampshire, United Kingdom, SO16 0YD
- Local Institution - 0349
-
Contact:
- Site 0349
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London, City Of
-
London, London, City Of, United Kingdom, NW1 2PG
- Local Institution - 0342
-
Contact:
- Site 0342
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-
-
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Alabama
-
Birmingham, Alabama, United States, 35294
- Local Institution - 0151
-
Contact:
- Site 0151
-
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California
-
Los Angeles, California, United States, 90095
- Local Institution - 0088
-
Contact:
- Site 0088
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Stanford, California, United States, 94305
- Local Institution - 0358
-
Contact:
- Site 0358
-
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Connecticut
-
New Haven, Connecticut, United States, 06520
- Local Institution - 0355
-
Contact:
- Site 0355
-
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District of Columbia
-
Washington, District of Columbia, United States, 20007
- Local Institution - 0434
-
Contact:
- Site 0434
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Local Institution - 0323
-
Contact:
- Site 0323
-
-
Maryland
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Baltimore, Maryland, United States, 21218
- Local Institution - 0324
-
Contact:
- Site 0324
-
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Montana
-
Billings, Montana, United States, 59102
- Local Institution - 0435
-
Contact:
- Site 0435
-
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Local Institution - 0157
-
Contact:
- Site 0157
-
Summit, New Jersey, United States, 07901
- Local Institution - 0359
-
Contact:
- Site 0359
-
-
New York
-
Lake Success, New York, United States, 11042
- Local Institution - 0430
-
Contact:
- Site 0430
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New York, New York, United States, 10065
- Local Institution - 0396
-
Contact:
- Site 0396
-
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Ohio
-
Cincinnati, Ohio, United States, 45220
- Local Institution - 0306
-
Contact:
- Site 0306
-
Cleveland, Ohio, United States, 44109
- Local Institution - 0199
-
Contact:
- Site 0199
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15224
- Local Institution - 0437
-
Contact:
- Site 0437
-
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Rhode Island
-
Providence, Rhode Island, United States, 02903
- Local Institution - 0352
-
Contact:
- Site 0352
-
-
South Dakota
-
Watertown, South Dakota, United States, 57201
- Local Institution - 0420
-
Contact:
- Site 0420
-
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Texas
-
Dallas, Texas, United States, 75390-88520
- Local Institution - 0168
-
Contact:
- Site 0168
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Washington
-
Seattle, Washington, United States, 98109
- Local Institution - 0405
-
Contact:
- Site 0405
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.
Documented diagnosis of multiple myeloma (MM), and must:.
i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.
ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).
iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.
iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.
- Must have measurable disease (as determined by central laboratory).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.
Exclusion Criteria
- Active, uncontrolled, or suspected infection.
- Known current, or history of, central nervous system involvement of multiple myeloma.
- History or presence of clinically relevant CNS pathology.
- Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
- Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: Alnuctamab
|
Specified dose on specified days
Other Names:
|
Active Comparator: Arm B: Standard of Care Regimens
|
Specified dose on specified days
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free Survival (PFS)
Time Frame: Up to 5 years
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to response (TTR)
Time Frame: Up to 5 years
|
Up to 5 years
|
Duration of response (DOR)
Time Frame: Up to 5 years
|
Up to 5 years
|
Overall Survival (OS)
Time Frame: Up to 5 years
|
Up to 5 years
|
Incidence of serious adverse events (SAEs)
Time Frame: Up to 5 years
|
Up to 5 years
|
Overall response (OR)
Time Frame: Up to 5 years
|
Up to 5 years
|
Complete response (CR) or better
Time Frame: Up to 5 years
|
Up to 5 years
|
Very good partial response (VGPR) or better
Time Frame: Up to 5 years
|
Up to 5 years
|
Time to progression (TTP)
Time Frame: Up to 5 years
|
Up to 5 years
|
Time to next treatment (TTNT)
Time Frame: Up to 5 years
|
Up to 5 years
|
Progression-free survival 2 (PFS2)
Time Frame: Up to 5 years
|
Up to 5 years
|
Restricted mean DOR (RMDOR)
Time Frame: Up to 5 years
|
Up to 5 years
|
Minimal residual disease (MRD) negativity rate
Time Frame: Up to 5 years
|
Up to 5 years
|
Incidence of adverse events (AEs)
Time Frame: Up to 5 years
|
Up to 5 years
|
Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)
Time Frame: Up to 5 years
|
Up to 5 years
|
Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Pomalidomide
- Daratumumab
- Antibodies, Monoclonal
- Elotuzumab
Other Study ID Numbers
- CA058-1019
- 2023-509472-42 (Registry Identifier: EU Trial Number)
- U1111-1281-8227 (Registry Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.
Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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