ClinicalTrials.gov
History of Changes for Study: NCT05827016
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
Latest version (submitted June 3, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 11, 2023 None (earliest Version on record)
2 April 28, 2023 Contacts/Locations and Study Status
3 May 15, 2023 Contacts/Locations and Study Status
4 June 1, 2023 Contacts/Locations and Study Status
5 June 6, 2023 Contacts/Locations and Study Status
6 July 7, 2023 Recruitment Status, Contacts/Locations, Study Status, References and Oversight
7 August 31, 2023 Contacts/Locations and Study Status
8 September 1, 2023 Contacts/Locations and Study Status
9 September 28, 2023 Contacts/Locations and Study Status
10 September 29, 2023 Contacts/Locations and Study Status
11 October 24, 2023 Contacts/Locations and Study Status
12 November 13, 2023 Contacts/Locations and Study Status
13 December 3, 2023 Contacts/Locations and Study Status
14 December 14, 2023 Contacts/Locations, References and Study Status
15 January 4, 2024 Contacts/Locations and Study Status
16 January 9, 2024 Contacts/Locations and Study Status
17 January 11, 2024 Contacts/Locations and Study Status
18 February 6, 2024 Contacts/Locations, Study Status and Eligibility
19 February 26, 2024 Contacts/Locations and Study Status
20 March 20, 2024 Contacts/Locations and Study Status
21 April 9, 2024 Contacts/Locations, Study Status and References
22 May 6, 2024 Contacts/Locations, Study Status and References
23 May 13, 2024 Contacts/Locations and Study Status
24 May 20, 2024 Contacts/Locations and Study Status
25 May 28, 2024 Contacts/Locations and Study Status
26 June 3, 2024 Contacts/Locations and Study Status
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Study NCT05827016
Submitted Date:  April 11, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: IM048-022
Brief Title: A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
Official Title: A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
Secondary IDs: 2022-501515-14 [EudraCT Number]
U1111-1280-9492 [Registry Identifier: WHO]
Open or close this module Study Status
Record Verification: April 2023
Overall Status: Not yet recruiting
Study Start: June 15, 2023
Primary Completion: March 15, 2029 [Anticipated]
Study Completion: January 1, 2036 [Anticipated]
First Submitted: April 11, 2023
First Submitted that
Met QC Criteria:		 April 11, 2023
First Posted: April 24, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 April 11, 2023
Last Update Posted: April 24, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Iberdomide
CC-220
Lenalidomide
MM
NDMM
Maintenance
Autologous stem cell transplant
ASCTm
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1216 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A1: Iberdomide Dose 1 Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Arm A2: Iberdomide Dose 2 Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Arm A3: Iberdomide Dose 3 Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Active Comparator: Arm B: Lenalidomide Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid®
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival (PFS)
[ Time Frame: Up to 6 years ]
Secondary Outcome Measures:
1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment
[ Time Frame: Up to 6 years ]
2. Overall Survival
[ Time Frame: Up to 12 years ]
3. Recommended iberdomide dose for Stage 2
[ Time Frame: Up to 1 year ]
4. Area under the iberdomide plasma concentration-time curve from time zero to tau
[ Time Frame: Up to 1 year ]
5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)
[ Time Frame: Up to 1 year ]
6. Maximum iberdomide concentration (Cmax)
[ Time Frame: Up to 1 year ]
7. Time to maximum iberdomide plasma concentration (Tmax)
[ Time Frame: Up to 1 year ]
8. Number of participants with adverse events (AEs)
[ Time Frame: Up to 6 years ]
9. Progression-free survival on next line of treatment (PFS2)
[ Time Frame: Up to 6 years ]
10. Achieving MRD negativity in participants with CR or better at any time after the date of randomization
[ Time Frame: Up to 6 years ]
11. Conversion from MRD positive to MRD negative in participants with CR or better
[ Time Frame: Up to 6 years ]
12. Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments
[ Time Frame: Up to 6 years ]
13. Time to progression (TTP)
[ Time Frame: Up to 6 years ]
14. Time to next treatment (TTNT)
[ Time Frame: Up to 6 years ]
15. Best response achieved prior to progressive disease (PD)
[ Time Frame: Up to 6 years ]
16. Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30)
[ Time Frame: Up to 6 years ]
17. Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)
[ Time Frame: Up to 6 years ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria

  • Confirmed diagnosis of symptomatic multiple myeloma (MM)
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2
  • Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted
  • Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria

Exclusion Criteria

  • Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy
  • Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma
  • Known central nervous system/meningeal involvement of MM
  • Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years

Other protocol-defined inclusion/exclusion criteria apply
Open or close this module Contacts/Locations
Central Contact Person: BMS Study Connect Contact Center www.BMSStudyConnect.com
Telephone: 855-907-3286
Email: Clinical.Trials@bms.com
Central Contact Backup: First line of email MUST contain NCT # and Site #.
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations: United States, California
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Contact:Contact: Stefan Ciurea, Site 0010 713-745-0146
United States, Colorado
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012-5405
Contact:Contact: Robert Rifkin, Site 0202 303-388-4876
Poudre Valley Health Care
Fort Collins, Colorado, United States, 80528-3413
Contact:Contact: Steven Schuster, Site 0189 970-297-6150
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224-1865
Contact:Contact: Sikander Ailawadhi, Site 0007 904-953-0853
Woodlands Medical Specialists - Pensacola
Pensacola, Florida, United States, 32503-2339
Contact:Contact: Rami Owera, Site 0204 850-696-0147
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612-9416
Contact:Contact: Melissa Alsina, Site 0192 813-745-6886
Cleveland Clinic Florida
Weston, Florida, United States, 33331-3609
Contact:Contact: Chakra Chaulagain, Site 0003
United States, Georgia
The Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322-1013
Contact:Contact: Sagar Lonial, Site 0018 404-778-1900
Augusta University - Georgia Cancer Center
Augusta, Georgia, United States, 30912
Contact:Contact: Amany Keruakous, Site 0021 706-721-2505
United States, Illinois
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois, United States, 60637-1426
Contact:Contact: Benjamin Derman, Site 0237 847-275-8131
United States, Kansas
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas, United States, 66205-2003
Contact:Contact: Al-Ola Abdallah, Site 0015 918-261-6196
United States, Maryland
Maryland Oncology Hematology, PA- Clinton
Clinton, Maryland, United States, 20735-4230
Contact:Contact: Jose Mendoza, Site 0205
United States, Michigan
University of Michigan Rogel Comprehensive Cancer Center UMCCC
Ann Arbor, Michigan, United States, 48109-5000
Contact:Contact: Matthew Pianko, Site 0001 734-647-0118
Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit
Detroit, Michigan, United States, 48202-2610
Contact:Contact: Philip Kuriakose, Site 0257 313-916-1901
St. John Hospital and Medical Center - Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, United States, 48236-2858
United States, Minnesota
Mayo Clinic - Transplant Center - Rochester
Rochester, Minnesota, United States, 55905-0001
United States, Mississippi
Hattiesburg Clinic - Hematology & Oncology
Hattiesburg, Mississippi, United States, 39401
Contact:Contact: John Hrom, Site 0207 601-261-1700
United States, Missouri
Midwest Oncology Associates - Kansas City
Kansas City, Missouri, United States, 64132
Contact:Contact: Suman Kambhampati, Site 0017 816-276-4700
United States, New Hampshire
Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon, New Hampshire, United States, 03756-1000
Contact:Contact: Christi Ann Hayes, Site 0177 603-650-4628
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Contact:Contact: Mohamad Cherry, Site 0191 973-971-7906
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901-1914
Contact:Contact: Mansi Shah, Site 0260
United States, New York
NYU Langone Health
New York, New York, United States, 10016-6402
Contact:Contact: Gareth Morgan, Site 0180
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021-0005
Contact:Contact: Hani Hassoun, Site 0269
Columbia University Medical Center - Herbert Irving Pavilion Location
New York, New York, United States, 10032-3729
Contact:Contact: Divaya Bhutani, Site 0020 646-317-6303
United States, North Carolina
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina, United States, 28803-2493
Contact:Contact: Raymond Thertulien, Site 0005
United States, Ohio
Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd
Cincinnati, Ohio, United States, 45236-2725
Contact:Contact: Kruti Patel, Site 0238 513-751-2273
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact:Contact: Jason Valent, Site 0002 216-445-7238
Toledo Clinic Cancer Centers
Toledo, Ohio, United States, 43623
Contact:Contact: Ahmad Zarzour, Site 0013 419-479-5605
United States, Oregon
Willamette Valley Cancer Institute
Eugene, Oregon, United States, 97401
Contact:Contact: Christopher Yasenchak, Site 0203 541-988-7932
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Contact:Contact: Adam Binder, Site 0012
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Contact:Contact: Asya Varshavsky-Yanovsky, Site 0011
University of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Contact:Contact: Kathleen Dorritie, Site 0253 412-647-0864
Cancer Care Associates of York
York, Pennsylvania, United States, 17403-5049
Contact:Contact: Joseph Kannarkatt, Site 0178 717-741-9229
United States, Tennessee
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, United States, 37404-1130
Tennessee Oncology
Nashville, Tennessee, United States, 37203-1625
Contact:Contact: Jesus Berdeja, Site 0004 615-320-5090
United States, Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Contact:Contact: Moshe Levy, Site 0193 214-370-1846
UT Southwestern-Harold C. Simmons Cancer Center
Dallas, Texas, United States, 75390-0001
Contact:Contact: Larry Anderson, Site 0009 214-648-5906
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact:Contact: Robert Orlowski, Site 0006 713-792-2860
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-0001
Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center
Milwaukee, Wisconsin, United States, 53226-1222
Argentina
Local Institution - 0182
Córdoba, Argentina, X5000JHGQ
Contact:Contact: Site 0182
Argentina, B
Local Institution - 0184
Buenos Aires, B, Argentina, C1114AAN
Local Institution - 0259
Mar del Plata, B, Argentina, 7600
Contact:Contact: Site 0259
Local Institution - 0267
Pilar, B, Argentina, B1629AHJ
Contact:Contact: Site 0267
Argentina, Caba
Local Institution - 0183
Ciudad Autonoma Buenos Aires, Caba, Argentina, C1199ABB
Contact:Contact: Site 0183
Local Institution - 0227
Ciudad Autonoma Buenos Aires, Caba, Argentina, C1430EFA
Contact:Contact: Site 0227
Australia
Local Institution - 0078
Clayton, Australia, 3800
Contact:Contact: Site 0078
Local Institution - 0103
Nedlands, Australia, 6009
Local Institution - 0090
Randwick, Australia, 2031
Australia, New South Wales
Local Institution - 0244
Waratah, New South Wales, Australia, 2298
Contact:Contact: Site 0244
Australia, South Australia
Local Institution - 0088
Adelaide, South Australia, Australia, 5000
Contact:Contact: Site 0088
Australia, Victoria
Local Institution - 0220
Box Hill, Victoria, Australia, 3128
Contact:Contact: Site 0220
Local Institution - 0076
Heidelberg, Victoria, Australia, 3084
Austria
Local Institution - 0058
Linz, Austria, 4020
Contact:Contact: Site 0058
Local Institution - 0034
St. Pölten, Austria, 3100
Contact:Contact: Site 0034
Local Institution - 0056
Vienna, Austria, 1090
Contact:Contact: Site 0056
Belgium
Local Institution - 0035
Gilly, Belgium, 6060
Contact:Contact: Site 0035
Belgium, VWV
Local Institution - 0048
Kortrijk, VWV, Belgium, 8500
Contact:Contact: Site 0048
Brazil
Local Institution - 0190
Barretos, Brazil, 14784-400
Contact:Contact: Site 0190
Local Institution - 0083
Porto Alegre, Brazil, 90880-480
Contact:Contact: Site 0083
Local Institution - 0081
Ribeirao Preto, Brazil, 14051-140
Contact:Contact: Site 0081
Local Institution - 0082
Rio de Janeiro, Brazil, 20231-050
Contact:Contact: Site 0082
Local Institution - 0096
Rio de Janeiro, Brazil, 21941-913
Contact:Contact: Site 0096
Local Institution - 0098
Salvador, Brazil, 40110-150
Contact:Contact: Site 0098
Local Institution - 0194
Sao Paulo, Brazil, 01246-000
Contact:Contact: Site 0194
Brazil, PR
Local Institution - 0245
Curitiba, PR, Brazil, 80520-174
Contact:Contact: Site 0245
Brazil, RJ
Local Institution - 0214
Niterói, RJ, Brazil, 24020-096
Contact:Contact: Site 0214
Brazil, SP
Local Institution - 0241
São Paulo, SP, Brazil, 08270-070
Contact:Contact: Site 0241
Canada
Local Institution - 0270
Edmonton, Canada, T6G 1Z2
Contact:Contact: Site 0270
Local Institution - 0210
Quebec, Canada
Contact:Contact: Site 0210
Local Institution - 0213
Vancouver, Canada, V5Z 4C2
Canada, Ontario
Local Institution - 0208
Ottawa, Ontario, Canada, K1H 8L6
Contact:Contact: Site 0208
Chile
Local Institution - 0186
Santiago, Chile, 7500691
Contact:Contact: Site 0186
Local Institution - 0258
Temuco, Chile, 4810469
Contact:Contact: Site 0258
Local Institution - 0099
Vitacura, Chile, 7650567
Contact:Contact: Site 0099
Chile, Bi
Local Institution - 0089
Los Ángeles, Bi, Chile, 4440000
Contact:Contact: Site 0089
Chile, RM
Local Institution - 0086
Providencia, RM, Chile, 7500000
Contact:Contact: Site 0086
China
Local Institution - 0229
Beijing, China, 100853
Contact:Contact: Site 0229
Local Institution - 0212
Binzhou, China, 256603
Contact:Contact: Site 0212
Local Institution - 0234
Changsha, China, 410011
Contact:Contact: Site 0234
Local Institution - 0242
Chongqing, China, 400016
Contact:Contact: Site 0242
Local Institution - 0080
Hangzhou Shi, China, 310003
Contact:Contact: Site 0080
Local Institution - 0095
Nanchang Shi, China, 330002
Local Institution - 0231
Nanjing, China, 210029
Contact:Contact: Site 0231
Local Institution - 0247
Nanning Shi, China, 530021
Contact:Contact: Site 0247
Local Institution - 0077
Qingdao, China, 266071
Contact:Contact: Site 0077
Local Institution - 0087
Wenzhou Shi, China, 325000
Contact:Contact: Site 0087
Local Institution - 0248
Wuhan Shi, China, 430022
Contact:Contact: Site 0248
China, AH
Local Institution - 0196
Hefei, AH, China, 230001
Contact:Contact: Site 0196
China, Beijing
Local Institution - 0216
Beijing, Beijing, China, 101199
Contact:Contact: Site 0216
Local Institution - 0100
Beijing Shi, Beijing, China, 100020
Contact:Contact: Site 0100
China, Guangdong
Local Institution - 0079
Guangzhou, Guangdong, China, 510060
Contact:Contact: Site 0079
Local Institution - 0261
Guangzhou Shi, Guangdong, China, 510080
Contact:Contact: Site 0261
Local Institution - 0256
Shenzhen, Guangdong, China, 518028
Contact:Contact: Site 0256
China, HB
Local Institution - 0084
Wuhan, HB, China, 430200
Contact:Contact: Site 0084
China, Hainan
Local Institution - 0246
Zhengzhou, Hainan, China, 450004
Contact:Contact: Site 0246
China, Hunan
Local Institution - 0262
Changsha, Hunan, China, 410008
Contact:Contact: Site 0262
China, Jiangsu
Local Institution - 0266
Nanjing, Jiangsu, China, 210008
Contact:Contact: Site 0266
Local Institution - 0239
Xuzhou, Jiangsu, China, 221000
Contact:Contact: Site 0239
China, Jiangxi
Local Institution - 0263
Nanchang, Jiangxi, China, 330200
Contact:Contact: Site 0263
China, Jilin
Local Institution - 0091
Changchun, Jilin, China, 130021
Contact:Contact: Site 0091
China, Liaoning
Local Institution - 0094
Shenyang, Liaoning, China, 110022
Contact:Contact: Site 0094
China, Shaanxi
Local Institution - 0265
Xi'an City, Shaanxi, China, 710032
Contact:Contact: Site 0265
China, Shandong
Local Institution - 0240
Jinan, Shandong, China, 250012
Contact:Contact: Site 0240
China, Shanghai
Local Institution - 0271
Shanghai, Shanghai, China, 200003
Contact:Contact: Site 0271
Local Institution - 0223
Shanghai, Shanghai, China, 200020
Contact:Contact: Site 0223
China, Tianjin
Local Institution - 0085
Tianjin, Tianjin, China, 300011
Local Institution - 0102
Tianjin, Tianjin, China, 300020
Local Institution - 0249
Tianjin, Tianjin, China, 30060
Contact:Contact: Site 0249
China, Zhejiang
Local Institution - 0243
Hangzhou, Zhejiang, China, 310003
Contact:Contact: Site 0243
Colombia
Local Institution - 0217
Bogota, Colombia, 110111
Contact:Contact: Site 0217
Local Institution - 0211
Bogota, Colombia, 110131
Contact:Contact: Site 0211
Local Institution - 0101
Floridablanca, Colombia, 681004
Contact:Contact: Site 0101
Local Institution - 0179
Medellin, Colombia, 050022
Contact:Contact: Site 0179
Local Institution - 0093
Valledupar, Colombia, 200001
Contact:Contact: Site 0093
Czechia
Local Institution - 0036
Brno, Czechia, 625 00
Contact:Contact: Site 0036
Local Institution - 0049
Hradec Kralove, Czechia, 500 05
Local Institution - 0206
Olomouc, Czechia, 779 00
Contact:Contact: Site 0206
Local Institution - 0067
Ostrava, Czechia, 708 52
Contact:Contact: Site 0067
Local Institution - 0215
Prague, Czechia, 100 34
Contact:Contact: Site 0215
Local Institution - 0069
Praha, Czechia, 128 00
Contact:Contact: Site 0069
Denmark
Local Institution - 0028
Odense, Denmark, 5000
Contact:Contact: Site 0028
Finland
Local Institution - 0201
Kuopio, Finland, 70211
Contact:Contact: Site 0201
France
Local Institution - 0030
Amiens, France, 80054
Contact:Contact: Site 0030
Local Institution - 0235
Bayonne, France, 64109
Contact:Contact: Site 0235
Local Institution - 0055
Caen, France, 14033
Contact:Contact: Site 0055
Local Institution - 0050
Creteil, France, 94000
Contact:Contact: Site 0050
Local Institution - 0236
La Roche Sur Yon CEDEX 9, France, 85925
Contact:Contact: Site 0236
Local Institution - 0054
Lille, France, 59037
Contact:Contact: Site 0054
Local Institution - 0221
Limoges, France, 87042
Contact:Contact: Site 0221
Local Institution - 0222
Lyon, France, 69008
Contact:Contact: Site 0222
Local Institution - 0272
Nantes, France, 44093
Contact:Contact: Site 0272
Local Institution - 0254
Nice, France, 06189
Contact:Contact: Site 0254
Local Institution - 0033
Paris, France, 75010
Contact:Contact: Site 0033
Local Institution - 0219
Paris, France, 75012
Contact:Contact: Site 0219
Local Institution - 0228
Paris, France, 75013
Contact:Contact: Site 0228
Local Institution - 0066
Pierre Benite, France, 69495
Contact:Contact: Site 0066
Local Institution - 0051
Toulouse, France, 31059
Contact:Contact: Site 0051
Local Institution - 0061
Villejuif, France, 94805
Contact:Contact: Site 0061
Germany
Local Institution - 0037
Berlin, Germany, 13353
Contact:Contact: Site 0037
Local Institution - 0045
Freiburg, Germany, 79106
Contact:Contact: Site 0045
Local Institution - 0038
Jena, Germany, 07747
Contact:Contact: Site 0038
Local Institution - 0040
Tübingen, Germany, 72076
Contact:Contact: Site 0040
Germany, BW
Local Institution - 0092
Ulm, BW, Germany, 89081
Contact:Contact: Site 0092
Germany, Northwest
Local Institution - 0022
Dusseldorf, Northwest, Germany, 40225
Contact:Contact: Site 0022
Local Institution - 0026
Hamm, Northwest, Germany, 59073
Contact:Contact: Site 0026
Greece
Local Institution - 0233
Athens, Greece, 115 28
Contact:Contact: Site 0233
Local Institution - 0063
Thessaloniki, Greece, 546 39
Contact:Contact: Site 0063
Greece, B
Local Institution - 0209
Thessaloniki, B, Greece, 570 10
Contact:Contact: Site 0209
Greece, G
Local Institution - 0097
Rio, G, Greece, 265 04
Contact:Contact: Site 0097
Greece, I
Local Institution - 0185
Athina, I, Greece, 106 76
Contact:Contact: Site 0185
Hong Kong, HK
Local Institution - 0250
Hong Kong, HK, Hong Kong, 999077
Contact:Contact: Site 0250
Hungary, HB
Local Institution - 0062
Debrecen, HB, Hungary, 4032
Iceland
Local Institution - 0047
Haifa, Iceland, 31999
Contact:Contact: Site 0047
India
Local Institution - 0110
Bangalore, India, 560 001
Contact:Contact: Site 0110
Local Institution - 0135
Navi Mumbai, India, 410 210
Contact:Contact: Site 0135
India, CH
Local Institution - 0128
Chandigarh, CH, India, 160012
Contact:Contact: Site 0128
India, KL
Local Institution - 0109
Cochin, KL, India, 68202
Contact:Contact: Site 0109
India, MH
Local Institution - 0200
Kolhapur, MH, India, 416002
Contact:Contact: Site 0200
Local Institution - 0152
Nagpur, MH, India, 440030
Contact:Contact: Site 0152
Local Institution - 0123
Pune, MH, India, 411 004
Contact:Contact: Site 0123
Local Institution - 0142
Pune, MH, India, 411004
Contact:Contact: Site 0142
India, Odisha
Local Institution - 0124
Bhubaneswar, Odisha, India, 751007
Contact:Contact: Site 0124
India, WB
Local Institution - 0125
Kolkata, WB, India, 700 020
Contact:Contact: Site 0125
Israel
Local Institution - 0137
Beer Ya'Aqov, Israel, 70300
Contact:Contact: Site 0137
Local Institution - 0027
Hadera, Israel, 38100
Contact:Contact: Site 0027
Local Institution - 0060
Jerusalem, Israel, 91000
Contact:Contact: Site 0060
Local Institution - 0075
Jerusalem, Israel, 91031
Contact:Contact: Site 0075
Local Institution - 0108
Petah Tikva, Israel, 49100
Contact:Contact: Site 0108
Local Institution - 0131
Ramat Gan, Israel, 52621
Contact:Contact: Site 0131
Local Institution - 0136
Tel Aviv-Yafo, Israel, 64239
Contact:Contact: Site 0136
Local Institution - 0057
Tel Aviv-Yafo, Israel, 69710
Contact:Contact: Site 0057
Italy
Local Institution - 0041
Bergamo, Italy, 24127
Local Institution - 0042
Catanzaro, Italy, 88100
Contact:Contact: Site 0042
Local Institution - 0074
Naples, Italy, 80131
Contact:Contact: Site 0074
Local Institution - 0065
Rome, Italy, 00161
Contact:Contact: Site 0065
Italy, CT
Local Institution - 0053
Catania, CT, Italy, 95123
Contact:Contact: Site 0053
Italy, CZ
Local Institution - 0120
Catanzaro, CZ, Italy, 88100
Contact:Contact: Site 0120
Italy, GE
Local Institution - 0115
Genova, GE, Italy, 16132
Contact:Contact: Site 0115
Italy, MI
Local Institution - 0188
Milano, MI, Italy, 20122
Contact:Contact: Site 0188
Local Institution - 0071
Milano, MI, Italy, 20162
Contact:Contact: Site 0071
Italy, PI
Local Institution - 0139
Pisa, PI, Italy, 56127
Contact:Contact: Site 0139
Italy, RM
Local Institution - 0046
Roma, RM, Italy, 00168
Contact:Contact: Site 0046
Italy, TO
Local Institution - 0140
Torino, TO, Italy, 10126
Contact:Contact: Site 0140
Japan
Local Institution - 0141
Chiba-shi, Japan, 260-8677
Contact:Contact: Site 0141
Local Institution - 0118
Gifu-shi, Japan, 500-8513
Contact:Contact: Site 0118
Local Institution - 0133
Higashiibaraki-Gun, Japan, 311-3193
Contact:Contact: Site 0133
Local Institution - 0112
Hiroshima-shi, Japan, 730-8619
Contact:Contact: Site 0112
Local Institution - 0199
Isehara-shi, Japan, 259-1193
Contact:Contact: Site 0199
Local Institution - 0111
Kagoshima-Shi, Japan, 890-8520
Contact:Contact: Site 0111
Local Institution - 0197
Kamakura-Shi, Japan, 247-8533
Contact:Contact: Site 0197
Local Institution - 0144
Kanazawa-Shi, Japan, 920-8641
Contact:Contact: Site 0144
Local Institution - 0134
Kobe-Shi, Japan, 650-0047
Contact:Contact: Site 0134
Local Institution - 0122
Koto-Ku, Japan, 135-8550
Contact:Contact: Site 0122
Local Institution - 0198
Kumamoto-shi, Japan, 860-8556
Contact:Contact: Site 0198
Local Institution - 0121
Maebashi-Shi, Japan, 371-8511
Contact:Contact: Site 0121
Local Institution - 0150
Minato-ku, Japan, 105-8471
Contact:Contact: Site 0150
Local Institution - 0104
Nagasaki-Shi, Japan, 852-8511
Contact:Contact: Site 0104
Local Institution - 0143
Nagoya-Shi, Japan, 467-8602
Contact:Contact: Site 0143
Local Institution - 0268
Osakasayama-shi, Japan, 589-8511
Contact:Contact: Site 0268
Local Institution - 0148
Saitama-shi, Japan, 330-8503
Contact:Contact: Site 0148
Local Institution - 0105
Sapporo-shi, Japan, 003-0006
Contact:Contact: Site 0105
Local Institution - 0132
Sendai-shi, Japan, 983-8520
Contact:Contact: Site 0132
Local Institution - 0106
Shibukawa-shi, Japan, 377-0280
Contact:Contact: Site 0106
Local Institution - 0116
Shibuya-Ku, Japan, 150-8935
Contact:Contact: Site 0116
Local Institution - 0130
Shizuoka-shi, Japan, 411-8777
Contact:Contact: Site 0130
Korea, Republic of
Local Institution - 0145
Busan, Korea, Republic of, 49241
Contact:Contact: Site 0145
Local Institution - 0113
Goyang-si, Korea, Republic of, 410-769
Contact:Contact: Site 0113
Local Institution - 0114
Seoul, Korea, Republic of, 135-710
Contact:Contact: Site 0114
Korea, Republic of, Ulsan
Local Institution - 0225
Dong-Gu, Ulsan, Korea, Republic of, 44033
Contact:Contact: Site 0225
Mexico
Local Institution - 0107
Mexico city, Mexico, 04100
Contact:Contact: Site 0107
Mexico, CMX
Local Institution - 0127
Mexico, CMX, Mexico, 14080
Contact:Contact: Site 0127
Mexico, GTO
Local Institution - 0147
Guanajuato, GTO, Mexico, 37660
Contact:Contact: Site 0147
Mexico, MEX
Local Institution - 0146
Toluca De Lerdo, MEX, Mexico, 50090
Contact:Contact: Site 0146
Mexico, SON
Local Institution - 0264
Hermosillo, SON, Mexico, 83270
Contact:Contact: Site 0264
Netherlands
Local Institution - 0070
Dordrecht, Netherlands, 3300 AK
Netherlands, NH
Local Institution - 0129
Amsterdam, NH, Netherlands, 1081 HV
Contact:Contact: Site 0129
Poland
Local Institution - 0252
Gliwice, Poland, 44-102
Contact:Contact: Site 0252
Local Institution - 0039
Katowice, Poland, 40-749
Contact:Contact: Site 0039
Local Institution - 0059
Lodz, Poland, 93-509
Contact:Contact: Site 0059
Local Institution - 0044
Lublin, Poland, 20-134
Contact:Contact: Site 0044
Local Institution - 0119
Warsaw, Poland, 02-781
Contact:Contact: Site 0119
Local Institution - 0031
Wroclaw, Poland, 50-367
Poland, KP
Local Institution - 0149
Bydgoszcz, KP, Poland, 85-168
Contact:Contact: Site 0149
Poland, LD
Local Institution - 0251
Lodz, LD, Poland, 93-510
Poland, Pomorskie
Local Institution - 0195
Gdansk, Pomorskie, Poland, 80-211
Contact:Contact: Site 0195
Portugal
Local Institution - 0023
Braga, Portugal, 4710-243
Contact:Contact: Site 0023
Local Institution - 0151
Coimbra, Portugal, 3000-075
Contact:Contact: Site 0151
Local Institution - 0126
Porto, Portugal, 4200-072
Contact:Contact: Site 0126
Portugal, Lisboa
Local Institution - 0255
Almada, Lisboa, Portugal, 2805-267
Romania
Local Institution - 0064
Cluj-Napoca, Romania, 400015
Contact:Contact: Site 0064
Local Institution - 0072
Cluj-Napoca, Romania, 400015
Contact:Contact: Site 0072
Romania, B
Local Institution - 0117
Bucureşti, B, Romania, 022328
Contact:Contact: Site 0117
Romania, Dolj
Local Institution - 0043
Craiova, Dolj, Romania, 200143
Contact:Contact: Site 0043
Romania, IS
Local Institution - 0224
Iasi, IS, Romania, 700483
Contact:Contact: Site 0224
Singapore
Local Institution - 0138
Singapore, Singapore, 119074
Contact:Contact: Site 0138
Local Institution - 0187
Singapore, Singapore, 169608
Contact:Contact: Site 0187
Spain
Local Institution - 0232
Badalona, Spain, 08916
Contact:Contact: Site 0232
Local Institution - 0164
Palma de Mallorca, Spain, 07120
Contact:Contact: Site 0164
Local Institution - 0163
Pamplona, Spain, 31008
Contact:Contact: Site 0163
Spain, Asturias
Local Institution - 0166
Oviedo, Asturias, Spain, 33011
Contact:Contact: Site 0166
Spain, B
Local Institution - 0226
Barcelona, B, Spain, 08036
Contact:Contact: Site 0226
Spain, CC
Local Institution - 0169
Cáceres, CC, Spain, 10003
Contact:Contact: Site 0169
Spain, Las Palmas
Local Institution - 0172
Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
Contact:Contact: Site 0172
Spain, MU
Local Institution - 0155
Murcia, MU, Spain, 30120
Contact:Contact: Site 0155
Spain, VC
Local Institution - 0174
Valencia, VC, Spain, 46026
Contact:Contact: Site 0174
Swaziland
Local Institution - 0168
Aarau 1, Swaziland, 5001
Contact:Contact: Site 0168
Sweden
Local Institution - 0230
Goeteborg, Sweden, 413 46
Contact:Contact: Site 0230
Local Institution - 0170
Helsingborg, Sweden, 254 37
Local Institution - 0218
Linkoping, Sweden, 581 85
Sweden, AB
Local Institution - 0157
Stockholm, AB, Sweden, 141 86
Contact:Contact: Site 0157
Sweden, BD
Local Institution - 0171
Luleå, BD, Sweden, 971 80
Contact:Contact: Site 0171
Taiwan
Local Institution - 0153
Kao-Hsiung, Taiwan, 83301
Contact:Contact: Site 0153
Local Institution - 0175
Kaohsiung, Taiwan, 82445
Contact:Contact: Site 0175
Local Institution - 0159
New Taipei City, Taiwan, 220
Contact:Contact: Site 0159
Local Institution - 0165
Tainan, Taiwan, 704
Contact:Contact: Site 0165
Turkey
Local Institution - 0167
Ankara, Turkey, 06230
Contact:Contact: Site 0167
Local Institution - 0158
Bornova, Turkey, 35100
Contact:Contact: Site 0158
Local Institution - 0052
Edirne, Turkey, 22030
Contact:Contact: Site 0052
Local Institution - 0068
Istanbul, Turkey, 34214
Contact:Contact: Site 0068
Local Institution - 0073
Izmir, Turkey, 35575
Contact:Contact: Site 0073
Local Institution - 0024
Kayseri, Turkey, 38039
Contact:Contact: Site 0024
Local Institution - 0032
Yenimahalle, Turkey, 06200
Contact:Contact: Site 0032
United Kingdom
Local Institution - 0160
Edinburgh, United Kingdom, EH4 2XU
Contact:Contact: Site 0160
Local Institution - 0025
London, United Kingdom, W1G 6AF
Contact:Contact: Site 0025
Local Institution - 0029
Oxford, United Kingdom, OX4 6LB
Contact:Contact: Site 0029
Local Institution - 0161
Windsor, United Kingdom, SL4 3HD
Contact:Contact: Site 0161
United Kingdom, ABD
Local Institution - 0173
Aberdeen, ABD, United Kingdom, AB25 2ZN
Contact:Contact: Site 0173
United Kingdom, DBY
Local Institution - 0156
Derby, DBY, United Kingdom, DE22 3NE
Contact:Contact: Site 0156
United Kingdom, DOR
Local Institution - 0162
Bournemouth, DOR, United Kingdom, BH7 7DW
Contact:Contact: Site 0162
United Kingdom, STS
Local Institution - 0154
Stafford, STS, United Kingdom, ST16 3SA
Contact:Contact: Site 0154
Open or close this module IPDSharing
Plan to Share IPD: Yes

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
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:
See Plan Description
Access Criteria:
See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Open or close this module References
Citations:
Links: Description: BMS Clinical Trial Information
Description: BMS Clinical Trial Patient Recruiting
Description: Investigator Inquiry Form
Description: FDA Safety Alerts and Recalls
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services