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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06152575




Registration number
NCT06152575
Ethics application status
Date submitted
17/11/2023
Date registered
30/11/2023
Date last updated
10/06/2025

Titles & IDs
Public title
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
Scientific title
A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
Secondary ID [1] 0 0
2023-507871-23-00
Secondary ID [2] 0 0
C1071032
Universal Trial Number (UTN)
Trial acronym
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 - Elranatamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib
Treatment: Drugs - Carfilzomib

Experimental: Elranatamab - Participants will receive elranatamab monotherapy

Active comparator: Investigator's Choice - Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)


Treatment: Drugs: Elranatamab
Elranatamab will be administered subcutaneously

Treatment: Drugs: Elotuzumab
Elotuzumab will be administered intravenously

Treatment: Drugs: Pomalidomide
Pomalidomide will be administered orally

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally

Treatment: Drugs: Bortezomib
Bortezomib will be administered subcutaneously or intravenously

Treatment: Drugs: Carfilzomib
Carfilzomib will be administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival per International Myeloma Working Group criteria
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Progression free survival on next-line treatment per International Myeloma Working Group criteria
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Objective response rate per International Myeloma Working Group criteria
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Duration of response per International Myeloma Working Group criteria
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Very good partial response or better response rate per International Myeloma Working Group criteria
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Complete response rate per International Myeloma Working Group criteria
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Duration of complete response per International Myeloma Working Group criteria
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Time to response per International Myeloma Working Group criteria
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Minimal residual disease negativity rate per International Myeloma Working Group criteria
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Frequency of treatment-emergent adverse events
Timepoint [12] 0 0
From date of first dose of study intervention up to 90 days after last study intervention administration
Secondary outcome [13] 0 0
Frequency of abnormal laboratory results
Timepoint [13] 0 0
From date of first dose of study intervention up to 90 days after last study intervention administration
Secondary outcome [14] 0 0
Free elranatamab serum trough concentration [Ctrough]
Timepoint [14] 0 0
From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
Secondary outcome [15] 0 0
Elranatamab immunogenicity by anti-drug antibodies against elranatamab
Timepoint [15] 0 0
From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
Secondary outcome [16] 0 0
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Timepoint [16] 0 0
From date of informed consent up to approximately 35 days after last administration of study intervention
Secondary outcome [17] 0 0
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Timepoint [17] 0 0
From date of informed consent up to approximately 35 days after last administration of study intervention

Eligibility
Key inclusion criteria
* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
* Measurable disease defined as at least 1 of the following: (a) Serum M-protein =0.5 g/dL; (b) Urinary M-protein excretion =200 mg/24 hours; (c) Serum involved immunoglobulin FLC =10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
* Have clinical laboratory values within the specified range.
* ECOG (Eastern Cooperative Oncology Group) performance status =2.
* Not pregnant or breastfeeding and willing to use contraception.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Smoldering multiple myeloma.
* Plasma cell leukemia.
* Amyloidosis.
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
* Any active, uncontrolled bacterial, fungal, or viral infection.
* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
* Unable to receive investigator's choice therapy.
* Live attenuated vaccine within 4 weeks of the first dose of study intervention.
* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.

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
8/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
492
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
St Vincent's Hospital (Melbourne) - Fitzroy
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
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United States of America
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Nebraska
Country [7] 0 0
United States of America
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New Jersey
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United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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West Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autónoma DE Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
La Plata
Country [18] 0 0
Belgium
State/province [18] 0 0
Bruxelles-capitale, Région DE
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Belgium
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Hainaut
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Belgium
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Liège
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Belgium
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Namur
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Belgium
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Oost-vlaanderen
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Brazil
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RIO Grande DO SUL
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Brazil
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SÃO Paulo
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Brazil
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Rio de Janeiro
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Brazil
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São Paulo
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Canada
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Alberta
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New Brunswick
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Quebec
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Czechia
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Brno-mesto
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Olomoucký KRAJ
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Czechia
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Praha 10
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Czechia
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Praha 2
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Denmark
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Hovedstaden
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Denmark
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Midtjylland
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Denmark
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Nordjylland
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Finland
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Pirkanmaa
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Finland
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Pohjois-pohjanmaa
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Finland
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Pohjois-savo
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Finland
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Uusimaa
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Finland
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Varsinais-suomi
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France
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Alpes-maritimes
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France
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Aquitaine
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France
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Lorraine
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France
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Nord-pas-de-calais
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France
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Pays-de-la-loire
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France
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Val-d'oise
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France
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Val-de-marne
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France
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Vendée
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France
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Bayonne
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France
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Le Mans
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France
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Paris
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France
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Quimper
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France
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Tours
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France
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Vannes
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Germany
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Baden-württemberg
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Germany
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Bayern
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Germany
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Thüringen
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Germany
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Berlin
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Germany
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Cottbus
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Germany
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Hamburg
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Germany
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Hamm
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Germany
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Speyer
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Greece
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Anatolikí Makedonía KAI Thráki
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Greece
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Attikí
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Greece
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Kentrikí Makedonía
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Greece
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Thessaloníki
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Greece
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Ípeiros
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Israel
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Hamerkaz
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Tell Abib
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Yerushalayim
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Italy
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Emilia-romagna
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Marche
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Sicilia
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Toscana
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Bologna
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Aichi
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Tokyo
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Yamanashi
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Kagoshima
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Kyoto
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Japan
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Okayama
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Japan
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Yamagata
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Korea, Republic of
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Seoul-teukbyeolsi [seoul]
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Netherlands
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Limburg
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Netherlands
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Zuid-holland
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Norway
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Akershus
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Norway
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Sør-trøndelag
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Norway
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Vestfold
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Norway
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Oslo
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Spain
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Barcelona [barcelona]
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Spain
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Catalunya [cataluña]
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Spain
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Galicia [galicia]
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Spain
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Girona [gerona]
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Spain
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Madrid, Comunidad DE
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Spain
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Valenciana, Comunitat
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Salamanca
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Spain
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València
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Sweden
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Falun
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Sweden
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Örebro LÄN [se-18]
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Taiwan
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Taichung
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United Kingdom
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Dorset
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United Kingdom
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EAST Sussex
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United Kingdom
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England
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Kent
Country [118] 0 0
United Kingdom
State/province [118] 0 0
London, CITY OF
Country [119] 0 0
United Kingdom
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Oxfordshire
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United Kingdom
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Staffordshire
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United Kingdom
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Sutton
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Canterbury
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06152575