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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05552976




Registration number
NCT05552976
Ethics application status
Date submitted
21/09/2022
Date registered
23/09/2022

Titles & IDs
Public title
A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)
Scientific title
A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2
Secondary ID [1] 0 0
CA057-008
Universal Trial Number (UTN)
Trial acronym
SUCCESSOR-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mezigdomide
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Dexamethasone

Experimental: MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) -

Active comparator: Kd (Carfilzomib + Dexamethasone) -


Treatment: Drugs: Mezigdomide
Specified dose on specified days

Treatment: Drugs: Carfilzomib
Specified dose on specified days

Treatment: Drugs: Dexamethasone
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Recommended Mezigdomide Dose
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone
Timepoint [2] 0 0
Up to 176 days
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Overall Response (OR)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Complete Response (CR) Or Better (CRR)
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Time To Response (TTR)
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Duration Of Response (DOR)
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Time To Progression (TTP)
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Time To Next Treatment (TTNT)
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
Progression-free Survival 2 (PFS-2)
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Minimal Residual Disease (MRD) Negativity Rate
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Number Of Participants With Adverse Events (AEs)
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
Timepoint [15] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.

i) Myeloma-protein (M-protein) = 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.

ii) M-protein = 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal ?/? free light chain ratio.

* Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy).
* Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible).
* Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.
* Participant must have documented disease progression during or after their last antimyeloma regimen.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participant who has had prior treatment with mezigdomide or carfilzomib.
* Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/07/2029
Actual
Sample size
Target
525
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Port Macquarie - Mid North Coast Cancer Institute - Port Macquarie
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Local Institution - 0229 - Hobart
Recruitment hospital [8] 0 0
Bendigo Health Care Group - Bendigo
Recruitment hospital [9] 0 0
Epworth Freemasons - East Melbourne
Recruitment hospital [10] 0 0
Austin Health - Heidelberg
Recruitment hospital [11] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2010 - Sydney
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3550 - Bendigo
Recruitment postcode(s) [9] 0 0
3002 - East Melbourne
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
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Delaware
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United States of America
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Georgia
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United States of America
State/province [5] 0 0
Idaho
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United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
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United States of America
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New York
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North Carolina
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Ohio
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United States of America
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Rhode Island
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South Carolina
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United States of America
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Tennessee
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Texas
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United States of America
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Washington
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United States of America
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Tucumán
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Argentina
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Córdoba
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Austria
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Wien
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Austria
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Linz
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Brazil
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Bahia
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São Paulo
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Brazil
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Rio de Janeiro
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Bulgaria
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Sofia (stolitsa)
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Bulgaria
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Plovdiv
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Sofia
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Canada
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Nova Scotia
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Ontario
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Quebec
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China
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Anhui
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Beijing
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Fujian
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Guangdong
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Henan
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China
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Jiangxi
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China
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Jilin
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China
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Liaoning
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China
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Shaanxi
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China
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Shandong
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China
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Cesar
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Sjælland
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Syddanmark
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Bayern
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Niedersachsen
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Schleswig-Holstein
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Thüringen
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Berlin
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Dresden
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Heidelberg
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Köln
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Leipzig
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Nürnberg
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Ulm
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Wuerzburg
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Greece
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Acha?a
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Attikí
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Hksar
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Baranya
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Hajdú-Bihar
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Budapest
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Delhi
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Haryana
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Karnataka
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Maharashtra
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India
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Punjab
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India
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Tamil Nadu
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India
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Telangana
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India
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Chandigarh
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Israel
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HaMerkaz
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Israel
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Jerusalem
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Israel
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Zerifin
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Milano
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Italy
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Bologna
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Italy
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Catanzaro
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Italy
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Lecce
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Italy
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Pisa
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Italy
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Udine
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Ibaraki
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Japan
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Ishikawa
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Japan
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Iwate
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Japan
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Kanagawa
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Yamanashi
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Nagasaki
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Okayama
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Japan
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Osaka
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Netherlands
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Noord-Brabant
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Netherlands
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Enschede
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Hordaland
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Norway
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Rogaland
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Norway
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Oslo
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Puerto Rico
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San Juan
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Romania
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Bucure?ti
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Romania
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Timi?
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Romania
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Brasov
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Romania
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Sibiu
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Singapore
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Central Singapore
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Spain
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Barcelona [Barcelona]
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Spain
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Madrid, Comunidad De
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Spain
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Santa Cruz De Tenerife
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Spain
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Valenciana, Comunitat
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Spain
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Granada
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Spain
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Madrid
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Spain
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Málaga
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Taiwan
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Chiayi
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
State/province [141] 0 0
Devon
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United Kingdom
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England
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United Kingdom
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Birmingham
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United Kingdom
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Glasgow
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United Kingdom
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Leeds
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers 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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05552976