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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04484623




Registration number
NCT04484623
Ethics application status
Date submitted
21/07/2020
Date registered
23/07/2020

Titles & IDs
Public title
Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
Scientific title
A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)
Secondary ID [1] 0 0
2018-004354-21
Secondary ID [2] 0 0
207499
Universal Trial Number (UTN)
Trial acronym
DREAMM 8
Linked study record

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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Belantamab mafodotin
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib

Experimental: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone -

Active comparator: Arm B: Bortezomib plus Pomalidomide and Dexamethasone -


Treatment: Drugs: Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.

Treatment: Drugs: Pomalidomide
Immunomodulatory drug (IMiD) will be administered.

Treatment: Drugs: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity will be administered.

Treatment: Drugs: Bortezomib
Proteasome Inhibitor will be administered.
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 174 weeks
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 473 weeks
Secondary outcome [2] 0 0
Duration of Response (DoR)
Timepoint [2] 0 0
Up to approximately 473 weeks
Secondary outcome [3] 0 0
Minimal Residual Disease (MRD) Negativity Rate
Timepoint [3] 0 0
Up to approximately 473 weeks
Secondary outcome [4] 0 0
Overall Response Rate (ORR)
Timepoint [4] 0 0
Up to approximately 473 weeks
Secondary outcome [5] 0 0
Complete Response Rate (CRR)
Timepoint [5] 0 0
Up to approximately 473 weeks
Secondary outcome [6] 0 0
Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better
Timepoint [6] 0 0
Up to approximately 473 weeks
Secondary outcome [7] 0 0
Time to Best Response (TTBR)
Timepoint [7] 0 0
Up to approximately 473 weeks
Secondary outcome [8] 0 0
Time to Response (TTR)
Timepoint [8] 0 0
Up to approximately 473 weeks
Secondary outcome [9] 0 0
Time to Progression (TTP)
Timepoint [9] 0 0
Up to approximately 473 weeks
Secondary outcome [10] 0 0
Progression-Free Survival 2 (PFS2)
Timepoint [10] 0 0
Up to approximately 473 weeks
Secondary outcome [11] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [11] 0 0
Up to approximately 473 weeks
Secondary outcome [12] 0 0
Number of Participants With Clinically Significant Changes in Hematology Parameters
Timepoint [12] 0 0
Up to approximately 473 weeks
Secondary outcome [13] 0 0
Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters
Timepoint [13] 0 0
Up to approximately 473 weeks
Secondary outcome [14] 0 0
Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
Timepoint [14] 0 0
Up to approximately 473 weeks
Secondary outcome [15] 0 0
Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points
Timepoint [15] 0 0
Up to approximately 473 weeks
Secondary outcome [16] 0 0
Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points
Timepoint [16] 0 0
Up to approximately 473 weeks
Secondary outcome [17] 0 0
Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide
Timepoint [17] 0 0
Up to approximately 473 weeks
Secondary outcome [18] 0 0
Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide
Timepoint [18] 0 0
Up to approximately 473 weeks
Secondary outcome [19] 0 0
Maximum Concentration (Cmax) for Pomalidomide
Timepoint [19] 0 0
Up to approximately 473 weeks
Secondary outcome [20] 0 0
Time of Cmax (Tmax) for Pomalidomide
Timepoint [20] 0 0
Up to approximately 473 weeks
Secondary outcome [21] 0 0
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide
Timepoint [21] 0 0
Up to approximately 473 weeks
Secondary outcome [22] 0 0
Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide
Timepoint [22] 0 0
Up to approximately 473 weeks
Secondary outcome [23] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Timepoint [23] 0 0
Up to approximately 473 weeks
Secondary outcome [24] 0 0
Titers of ADAs Against Belantamab Mafodotin
Timepoint [24] 0 0
Up to approximately 473 weeks
Secondary outcome [25] 0 0
Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)
Timepoint [25] 0 0
Up to approximately 473 weeks
Secondary outcome [26] 0 0
Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
Timepoint [26] 0 0
Up to approximately 473 weeks
Secondary outcome [27] 0 0
Change From Baseline in Quality of Life Questionnaire 20-item Multiple Myeloma Module (QLQMY20)
Timepoint [27] 0 0
Up to approximately 473 weeks
Secondary outcome [28] 0 0
Change From Baseline in HRQoL as Measured by EORTC IL52
Timepoint [28] 0 0
Up to approximately 473 weeks

Eligibility
Key inclusion criteria
* Capable of giving signed informed consent.
* Male or female, 18 years or older.
* Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide =10 mg daily for at least 2 consecutive cycles are eligible).
* Must have at least 1 aspect of measurable disease defined as one of the following;

1. Urine M-protein excretion greater than or equal to (=)200 milligrams (mg) per 24-hour, or
2. Serum M-protein concentration =0.5 grams/deciliters (g/dL) (=5.0 g/liter [L]), or
3. Serum free light chain (FLC) assay: involved FLC level =10 mg/dL (=100 mg/L) and an abnormal serum free light chain ratio (less than [<]0.26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike.
* Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
* All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (=)Grade 1 at the time of enrolment, except for alopecia.
* Adequate organ system functions as mentioned in the protocol.
* Male and female participants agree to abide by protocol-defined contraceptive requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
* Prior allogeneic SCT.
* Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
* Plasmapheresis within 7 days prior to the first dose of study drug.
* Received prior treatment with or intolerant to pomalidomide.
* Received prior Beta cell maturation antigen (BCMA) targeted therapy.
* Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice weekly).
* Evidence of cardiovascular risk including any of the following;

1. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
2. Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting .
3. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
4. Uncontrolled hypertension.
* Any major surgery within the last 4 weeks.
* Previous or concurrent invasive malignancy other than multiple myeloma, except:

1. The disease must be considered medically stable for at least 2 years; or
2. The participant must not be receiving active therapy, other than hormonal therapy for this disease.
* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
* Evidence of active mucosal or internal bleeding.
* Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
* Active infection requiring treatment.
* Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met.
* Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
* Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or =Grade 3 peripheral neuropathy.
* Active or history of venous and arterial thromboembolism within the past 3 months.
* Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
* Current corneal disease except for mild punctate keratopathy.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
* Pregnant or lactating female.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/10/2029
Actual
Sample size
Target
Accrual to date
Final
302
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Gosford NSW
Recruitment hospital [4] 0 0
GSK Investigational Site - Port Macquarie
Recruitment hospital [5] 0 0
GSK Investigational Site - Benowa
Recruitment hospital [6] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [7] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [8] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [9] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [10] 0 0
GSK Investigational Site - Malvern
Recruitment hospital [11] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2250 - Gosford NSW
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
Brazil
State/province [6] 0 0
Curitiba
Country [7] 0 0
Brazil
State/province [7] 0 0
Joinville
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
SAo Paulo
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Changchun
Country [12] 0 0
China
State/province [12] 0 0
Changsha
Country [13] 0 0
China
State/province [13] 0 0
Hangzhou
Country [14] 0 0
China
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Jiangsu
Country [15] 0 0
China
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Nanchang
Country [16] 0 0
China
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Shenyang
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China
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Tianjin
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha 2
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France
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Marseille
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France
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Toulouse cedex 9
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France
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Vanduvre-lEs-Nancy
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Germany
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Mainz
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Germany
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Tuebingen
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Germany
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Wuerzburg
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Thessaloniki
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Nahariya
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Hokkaido
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Iwate
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Okayama
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Osaka
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Tottori
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Yamagata
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Gyeonggi-do
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Hwasun
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Inchon
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Dunedin
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New Zealand
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Grafton
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New Zealand
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Hamilton
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Takapuna Auckland
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Tauranga
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Gdansk
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Novosibirsk
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Russian Federation
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Russian Federation
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Samara
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Russian Federation
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Sochi
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Barcelona
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Gijon
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Spain
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L'Hospitalet De Llobrega
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Spain
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Madrid
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Spain
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MOstoles Madrid
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Spain
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Murcia
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Spain
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Palma de Mallorca
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Spain
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PamplonaNavarra
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Spain
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Pozuelo De AlarcOn Madr
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia
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Turkey
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Ankara
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Turkey
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Izmir
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Kocaeli
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Mersin
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Turkey
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Samsun
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United Kingdom
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London
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United Kingdom
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Plymouth
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United Kingdom
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Southampton
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United Kingdom
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Stoke on Trent
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04484623