History of Changes for Study: NCT06045806

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)

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Study Record Versions

Version	Submitted Date	Changes
1	September 13, 2023	None (earliest Version on record)
2	September 22, 2023	Contacts/Locations and Study Status
3	September 26, 2023	Contacts/Locations and Study Status
4	October 19, 2023	Recruitment Status, Contacts/Locations and Study Status
5	October 25, 2023	Contacts/Locations and Study Status
6	October 27, 2023	Contacts/Locations and Study Status
7	November 6, 2023	Contacts/Locations and Study Status
8	November 29, 2023	Contacts/Locations and Study Status
9	November 30, 2023	Contacts/Locations and Study Status
10	December 3, 2023	Study Status and Contacts/Locations
11	December 6, 2023	Contacts/Locations and Study Status
12	December 14, 2023	References, Contacts/Locations and Study Status
13	January 2, 2024	Contacts/Locations and Study Status
14	January 4, 2024	Contacts/Locations and Study Status
15	January 5, 2024	Contacts/Locations and Study Status
16	January 9, 2024	Contacts/Locations and Study Status
17	January 10, 2024	Contacts/Locations and Study Status
18	January 25, 2024	Contacts/Locations, References and Study Status
19	February 20, 2024	Contacts/Locations, Study Status and Eligibility
20	March 18, 2024	Contacts/Locations, Study Status and References
21	March 29, 2024	Contacts/Locations and Study Status
22	April 9, 2024	Contacts/Locations, Study Status and References
23	May 9, 2024	Contacts/Locations, Sponsor/Collaborators, Study Status, Study Identification and References

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CA089-1043
Brief Title:	A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Official Title:	A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Secondary IDs:	2022-501346-30 [EudraCT Number] U1111-1280-9736 [WHO]

Study Status


Record Verification:	September 2023
Overall Status:	Not yet recruiting
Study Start:	September 27, 2023
Primary Completion:	March 27, 2031 [Anticipated]
Study Completion:	July 4, 2032 [Anticipated]

First Submitted:	September 13, 2023
First Submitted that Met QC Criteria:	September 13, 2023
First Posted:	September 21, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	September 13, 2023
Last Update Posted:	September 21, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


Brief Summary:	The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
Detailed Description:

Conditions


Conditions:	Multiple Myeloma
Keywords:	CAR-T

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	618 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Arm A	Biological: idecabtagene vicleucel Specified dose on specified days Other Names: BMS-986395 Abecma bb2121 ide-cel Drug: Lenalidomide Specified dose on specified days Other Names: Revlimid LEN Drug: Fludarabine Specified dose on specified days Other Names: FLUDARA BENDARBIN Drug: Cyclophosphamide Specified dose on specified days Other Names: ENDOXAN CYTOXAN
Active Comparator: Arm B	Drug: Lenalidomide Specified dose on specified days Other Names: Revlimid LEN

Outcome Measures


Primary Outcome Measures:
1.	Progression Free Survival (PFS) [ Time Frame: Up to approximately 49 months after the first participant is randomized ] PFS as assessed by Independent Review Committee (IRC)
Secondary Outcome Measures:
1.	Overall Survival (OS) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
2.	Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months [ Time Frame: From randomization up to 27 months from randomization ]
3.	Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) [ Time Frame: From randomization up to 15 months from randomization ]
4.	Event-Free Survival (EFS) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
5.	Duration of Response (DOR) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
6.	Percentage of Participants with Complete Response (CR) [ Time Frame: Up to approximately 60 months after the last participant is randomized ] CR as assessed by IRC
7.	Time to Progression (TTP) [ Time Frame: Up to approximately 60 months after the last participant is randomized ] Progression as assessed by IRC
8.	Progression post-next line of treatment (PFS2) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
9.	Time to Next Treatment (TTNT) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
10.	Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
11.	Number of Participants Experiencing Adverse Events of Special Interest (AESI) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
12.	Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
13.	Time of Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
14.	Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D]) [ Time Frame: Up to 28 days post infusion ]
15.	Time of Last Measurable Observed Plasma Concentration (Tlast) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
16.	Time-to-Definitive Deterioration [ Time Frame: Up to approximately 49 months after the first participant is randomized ] Time-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale
17.	Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales [ Time Frame: Up to approximately 49 months after the first participant is randomized ] The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed: Global health status/quality of life Physical Functioning Fatigue Pain
18.	Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales [ Time Frame: Up to approximately 49 months after the first participant is randomized ] The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed: Disease symptoms Side-effects of treatment

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN. Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction. Participant must have documented response of PR or VGPR at time of consent. Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion). Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy. Exclusion Criteria: Participant with known central nervous system involvement with myeloma. Participant has non-secretory MM. Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection. Participant has history of primary immunodeficiency. Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.

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 the email MUST contain the NCT# and Site #.
Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:	United States, Arizona
	Banner MD Anderson Cancer Center Gilbert, Arizona, United States, 85234 Contact:Contact: Rajneesh Nath, Site 0096 480-256-3223
	Mayo Clinic in Arizona - Scottsdale Scottsdale, Arizona, United States, 85259 Contact:Contact: Peter Bergsagel, Site 0097 480-342-4800
	United States, California
	University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento, California, United States, 95817 Contact:Contact: Mehrdad Abedi, Site 0113 916-734-3772
	Stanford University Medical Center Stanford, California, United States, 94305 Contact:Contact: Surbhi Sidana, Site 0099 650-723-0822
	United States, Colorado
	Colorado Blood Cancer Institute Denver, Colorado, United States, 80218 Contact:Contact: Tara Gregory, Site 0101 720-754-4800
	United States, Connecticut
	Yale University School of Medicine New Haven, Connecticut, United States, 06510 Contact:Contact: Noffar Bar, Site 0111 000-000-0000
	United States, Florida
	Mayo Clinic in Florida Jacksonville, Florida, United States, 32224 Contact:Contact: Sikander Ailawadhi, Site 0098 904-953-2000
	United States, Georgia
	Winship Cancer Institute, Emory University Atlanta, Georgia, United States, 30322 Contact:Contact: Nisha Joseph, Site 0121 502-608-5503
	Northside Hospital Atlanta, Georgia, United States, 30342 Contact:Contact: Scott Solomon, Site 0104 404-255-1930
	United States, Massachusetts
	Massachusetts General Hospital Boston, Massachusetts, United States, 02114 Contact:Contact: Diana Cirstea, Site 0102 617-724-4000
	United States, Michigan
	Ascension Providence Hospital Southfield, Michigan, United States, 48075 Contact:Contact: Howard Terebelo, Site 0105 248-552-0620
	United States, Minnesota
	Mayo Clinic in Rochester, Minnesota Rochester, Minnesota, United States, 55905 Contact:Contact: Shaji Kumar, Site 0100 507-202-8384
	United States, Missouri
	Washington University School of Medicine Saint Louis, Missouri, United States, 63110 Contact:Contact: RAVI VIJ, Site 0103 314-409-4144
	United States, New York
	Columbia University Irving Medical Center New York, New York, United States, 10032 Contact:Contact: Ran Reshef, Site 0117 212-342-0530
	United States, North Carolina
	Wake Forest Baptist Health Winston-Salem, North Carolina, United States, 27157 Contact:Contact: John McKay, Site 0107 336-716-7972
	United States, Ohio
	University Hospitals Cleveland Medical Center Cleveland, Ohio, United States, 44106 Contact:Contact: Koen van Besien, Site 0116 216-844-0139
	The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus, Ohio, United States, 43210 Contact:Contact: Srinivas Devarakonda, Site 0106 570-423-0522
	United States, Texas
	UT Southwestern Medical Center Dallas, Texas, United States, 75390-88520 Contact:Contact: Gurbakhash Kaur, Site 0114 214-648-5364
	University of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030 Contact:Contact: Krina Patel, Site 0112 713-792-6662
	Australia, New South Wales
	Local Institution - 0007 Camperdown, New South Wales, Australia, 2050 Contact:Contact: Site 0007
	Australia, Queensland
	Local Institution - 0005 Brisbane, Queensland, Australia, 4029 Contact:Contact: Site 0005
	Australia, Victoria
	Local Institution - 0004 Melbourne, Victoria, Australia, 3000 Contact:Contact: Site 0004
	Local Institution - 0006 Melbourne, Victoria, Australia, 3004 Contact:Contact: Site 0006
	Local Institution - 0008 Melbourne, Victoria, Australia, 3065 Contact:Contact: Site 0008
	Australia, Western Australia
	Local Institution - 0011 Murdoch, Western Australia, Australia, 6150 Contact:Contact: Site 0011
	Austria
	Local Institution - 0089 Salzburg, Austria, 5020 Contact:Contact: Site 0089
	Local Institution - 0090 Wien, Austria, 1090 Contact:Contact: Site 0090
	Belgium, Bruxelles-Capitale, Région De
	Local Institution - 0083 Anderlecht, Bruxelles-Capitale, Région De, Belgium, 1070 Contact:Contact: Site 0083
	Local Institution - 0084 Brussels, Bruxelles-Capitale, Région De, Belgium, 1090 Contact:Contact: Site 0084
	Canada, Alberta
	Local Institution - 0003 Calgary, Alberta, Canada, T2N 4N2 Contact:Contact: Site 0003
	Canada, Ontario
	Local Institution - 0001 Hamilton, Ontario, Canada, L8V5C2 Contact:Contact: Site 0001
	Czechia
	Local Institution - 0033 Praha 2, Czechia, 12808 Contact:Contact: Site 0033
	Czechia, Brno-město
	Local Institution - 0036 Brno, Brno-město, Czechia, 625 00 Contact:Contact: Site 0036
	Czechia, Hradec Králové
	Local Institution - 0034 Hradec Kralove, Hradec Králové, Czechia, 500 05 Contact:Contact: Site 0034
	Czechia, Olomoucký Kraj
	Local Institution - 0035 Olomouc, Olomoucký Kraj, Czechia, 779 00 Contact:Contact: Site 0035
	Denmark, Syddanmark
	Local Institution - 0070 Odense, Syddanmark, Denmark, 5000 Contact:Contact: Site 0070
	France
	Hôpital Saint-Louis Paris, France, 75010 Contact:Contact: Bertrand Arnulf, Site 0082 33142499472
	Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE Toulouse, France, 31100 Contact:Contact: Aurore Perrot, Site 0092 0531156184
	France, Aquitaine
	CHU Bordeaux Haut-Leveque Pessac, Aquitaine, France, 33600 Contact:Contact: Cyrille Hulin, Site 0047 33557656511
	France, Bouches-du-Rhône
	Institut Paoli-Calmettes Marseille, Bouches-du-Rhône, France, 13273 Contact:Contact: Gabriel Brisou, Site 0045 +33647880806
	France, Nord
	Hopital Claude Huriez - CHU de Lille Lille, Nord, France, 59000 Contact:Contact: Salomon Manier, Site 0030 33320444292
	France, Pays-de-la-Loire
	Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes, Pays-de-la-Loire, France, 44000 Contact:Contact: Cyrille Touzeau, Site 0042 33240083271
	France, Rhône
	Centre Hospitalier Lyon Sud Pierre-Bénite, Rhône, France, 69310 Contact:Contact: Lionel Karlin, Site 0046 33478864309
	France, Val-de-Marne
	Henri Mondor Hospital Créteil, Val-de-Marne, France, 94010 Contact:Contact: Karim Balhadj-Merzoug, Site 0068 33149812798
	Gustave Roussy Villejuif, Val-de-Marne, France, 94800 Contact:Contact: Alina Danu, Site 0028 33142114229
	France, Vienne
	Centre Hospitalier Universitaire de Poitiers Poitiers, Vienne, France, 86021 Contact:Contact: xavier leleu, Site 0029 +33 982602178
	France, Île-de-France
	Hôpital Saint Antoine Paris, Île-de-France, France, 75571 Contact:Contact: Mohamad Mohty, Site 0031 33149282620
	Germany
	Local Institution - 0115 Essen, Germany, 45122 Contact:Contact: Site 0115
	Local Institution - 0076 Hamburg, Germany, 20246 Contact:Contact: Site 0076
	Germany, Baden-Württemberg
	Local Institution - 0072 Heidelberg, Baden-Württemberg, Germany, 69120 Contact:Contact: Site 0072
	Local Institution - 0078 Ulm, Baden-Württemberg, Germany, 89081 Contact:Contact: Site 0078
	Germany, Bayern
	Local Institution - 0077 Nuremberg, Bayern, Germany, 90419 Contact:Contact: Site 0077
	Local Institution - 0074 Wuerzburg, Bayern, Germany, 97080 Contact:Contact: Site 0074
	Germany, Nordrhein-Westfalen
	Local Institution - 0073 Köln, Nordrhein-Westfalen, Germany, 50937 Contact:Contact: Site 0073
	Germany, Sachsen
	Local Institution - 0079 Dresden, Sachsen, Germany, 01307 Contact:Contact: Site 0079
	Local Institution - 0087 Leipzig, Sachsen, Germany, 04103 Contact:Contact: Site 0087
	Germany, Schleswig-Holstein
	Local Institution - 0075 Kiel, Schleswig-Holstein, Germany, 24105 Contact:Contact: Site 0075
	Greece, Achaḯa
	Local Institution - 0063 Patras, Achaḯa, Greece, 26504 Contact:Contact: Site 0063
	Greece, Attikí
	Local Institution - 0061 Athens, Attikí, Greece, 106 76 Contact:Contact: Site 0061
	Local Institution - 0062 Chaidari, Attikí, Greece, 12462 Contact:Contact: Site 0062
	Greece, Thessaloníki
	Local Institution - 0060 Thessaloniki, Thessaloníki, Greece, 570 10 Contact:Contact: Site 0060
	Israel
	Local Institution - 0056 Haifa, Israel, 31096 Contact:Contact: Site 0056
	Local Institution - 0059 Jerusalem, Israel, 9112001 Contact:Contact: Site 0059
	Israel, HaDarom
	Local Institution - 0055 Be'er Sheva, HaDarom, Israel, 8410101 Contact:Contact: Site 0055
	Israel, HaMerkaz
	Local Institution - 0058 Petah-Tikva, HaMerkaz, Israel, 4910021 Contact:Contact: Site 0058
	Local Institution - 0057 Ramat Gan, HaMerkaz, Israel, 5262100 Contact:Contact: Site 0057
	Israel, Tell Abīb
	Local Institution - 0088 Tel Aviv, Tell Abīb, Israel, 6423906 Contact:Contact: Site 0088
	Italy
	Local Institution - 0065 Bologna, Italy, 40138 Contact:Contact: Site 0065
	Local Institution - 0066 Roma, Italy, 00161 Contact:Contact: Site 0066
	Italy, Milano
	Local Institution - 0064 Rozzano, Milano, Italy, 20089 Contact:Contact: Site 0064
	Italy, Piemonte
	Local Institution - 0067 Torino, Piemonte, Italy, 10126 Contact:Contact: Site 0067
	Japan
	Local Institution - 0049 Chiba, Japan, 260-8677 Contact:Contact: Site 0049
	Local Institution - 0054 Fukuoka, Japan, 812-8582 Contact:Contact: Site 0054
	Local Institution - 0053 Okayama, Japan, 700-8558 Contact:Contact: Site 0053
	Local Institution - 0071 Shimotsuke, Japan, 329-0498 Contact:Contact: Site 0071
	Local Institution - 0050 Tokyo, Japan, 150-8935 Contact:Contact: Site 0050
	Japan, Aichi
	Local Institution - 0052 Nagoya, Aichi, Japan, 467-8602 Contact:Contact: Site 0052
	Japan, Hokkaido
	Local Institution - 0048 Sapporo, Hokkaido, Japan, 060-8648 Contact:Contact: Site 0048
	Japan, Hyogo
	Local Institution - 0086 Nishinomiya, Hyogo, Japan, 663-8501 Contact:Contact: Site 0086
	Japan, Ishikawa
	Local Institution - 0051 Kanazawa, Ishikawa, Japan, 920-8641 Contact:Contact: Site 0051
	Japan, Kanagawa
	Local Institution - 0085 Isehara, Kanagawa, Japan, 259-1193 Contact:Contact: Site 0085
	Korea, Republic of, Jeonranamdo
	Local Institution - 0041 Hwasun Gun, Jeonranamdo, Korea, Republic of, 58128 Contact:Contact: Site 0041
	Korea, Republic of, Seoul-teukbyeolsi [Seoul]
	Local Institution - 0039 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080 Contact:Contact: Site 0039
	Local Institution - 0040 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505 Contact:Contact: Site 0040
	Local Institution - 0038 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351 Contact:Contact: Site 0038
	Local Institution - 0043 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06591 Contact:Contact: Site 0043
	Norway
	Local Institution - 0069 Oslo, Norway, 0450 Contact:Contact: Site 0069
	Poland, Lubelskie
	Local Institution - 0027 Lublin, Lubelskie, Poland, 20-090 Contact:Contact: Site 0027
	Poland, Mazowieckie
	Local Institution - 0095 Warsaw, Mazowieckie, Poland, 02-097 Contact:Contact: Site 0095
	Local Institution - 0023 Warsaw, Mazowieckie, Poland, 02-776 Contact:Contact: Site 0023
	Poland, Pomorskie
	Local Institution - 0026 Gdańsk, Pomorskie, Poland, 80-952 Contact:Contact: Site 0026
	Poland, Wielkopolskie
	Local Institution - 0024 Poznań, Wielkopolskie, Poland, 60-569 Contact:Contact: Site 0024
	Poland, Śląskie
	Local Institution - 0022 Gliwice, Śląskie, Poland, 44-101 Contact:Contact: Site 0022
	Romania, București
	Local Institution - 0091 Bucuresti, București, Romania, 022328 Contact:Contact: Site 0091
	Spain
	Local Institution - 0021 Madrid, Spain, 28041 Contact:Contact: Site 0021
	Local Institution - 0013 Salamanca, Spain, 37007 Contact:Contact: Site 0013
	Local Institution - 0014 València, Spain, 46026 Contact:Contact: Site 0014
	Spain, Barcelona [Barcelona]
	Local Institution - 0020 Badalona, Barcelona [Barcelona], Spain, 08916 Contact:Contact: Site 0020
	Local Institution - 0017 L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain, 08908 Contact:Contact: Site 0017
	Spain, Catalunya [Cataluña]
	Local Institution - 0016 Barcelona, Catalunya [Cataluña], Spain, 08036 Contact:Contact: Site 0016
	Spain, Navarra
	Local Institution - 0012 Pamplona, Navarra, Spain, 31008 Contact:Contact: Site 0012
	United Kingdom
	Local Institution - 0081 Glasgow, United Kingdom, G12 0YN Contact:Contact: Site 0081
	United Kingdom, England
	Local Institution - 0093 Birmingham, England, United Kingdom, B15 2TH Contact:Contact: Site 0093
	United Kingdom, London, City Of
	Local Institution - 0080 London, London, City Of, United Kingdom, SE5 9RS Contact:Contact: Site 0080
	Local Institution - 0094 London, London, City Of, United Kingdom, W12 0HS Contact:Contact: Site 0094

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/disclosure-commitment.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

References


Citations:
Links:	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Description: BMS Clinical Trial Information
	URL: https://www.bmsstudyconnect.com/s/US/English/USenHome Description: BMS Clinical Trial Patient Recruiting
	URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm Description: FDA Safety Alerts and Recalls
Available IPD/Information: