Clinical trial NCT05020236: A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
Official title: AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Elranatamab
PF-06863135
B-Cell Maturation Antigen
BCMA
Bispecific antibody
BCMA-CD3 bispecific antibody
Daratumumab
Pomalidomide
Multiple myeloma
Relapsed multiple myeloma
Refractory multiple myeloma
MagnetisMM-5
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study.

Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab.

People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab.

Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab.

All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.


Eligibility criteria: Inclusion Criteria:

* Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
* Measurable disease based on IMWG criteria as defined by at least 1 of the following:

  * Serum M-protein ≥0.5 g/dL.
  * Urinary M-protein excretion ≥200 mg/24 hours.
  * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
* Prior anti-multiple myeloma therapy including treatment with lenalidomide.
* ECOG performance status ≤2.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
* Not pregnant and willing to use contraception.

Exclusion Criteria:

* Smoldering multiple myeloma.
* Plasma cell leukemia.
* Amyloidosis.
* POEMS Syndrome.
* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
* Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
* Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
* Previous treatment with a BCMA-directed therapy.
* Live attenuated vaccine within 4 weeks of the first dose of study intervention.
* Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Primary outcomes:
measure: Part 1 Safety Lead-In: Incidence of dose limiting toxicities
timeFrame: First 42 days after first elranatamab dose
measure: Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
timeFrame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
measure: Part 3: Frequency of treatment-emergent adverse events
timeFrame: First 84 days after first elranatamab dose
Secondary outcomes:
measure: Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria
timeFrame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
measure: Overall survival
timeFrame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
measure: Objective response rate per International Myeloma Working Group criteria
timeFrame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
measure: Duration of response per International Myeloma Working Group criteria
timeFrame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
measure: Time to response per International Myeloma Working Group criteria
timeFrame: From date of randomization to date of confirmed objective response, assessed up to 51 months
measure: Complete response rate per International Myeloma Working Group criteria
timeFrame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
measure: Duration of complete response per International Myeloma Working Group criteria
timeFrame: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
measure: Minimal residual disease negativity rate per International Myeloma Working Group criteria
timeFrame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
measure: Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
timeFrame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
measure: Progression free survival on next-line treatment per International Myeloma Working Group criteria
timeFrame: From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
measure: Frequency of treatment-emergent adverse events
timeFrame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.
measure: Frequency of abnormal laboratory results
timeFrame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.
measure: Rate of Grade ≥2 cytokine release syndrome
timeFrame: First 28 days after first elranatamab dose
measure: Elranatamab pharmacokinetics by pre- and post-dose concentrations
timeFrame: From date of first dose through up to 14 days after date of last dose of elranatamab
measure: Elranatamab immunogenicity by anti-drug antibodies against elranatamab
timeFrame: From date of first dose through up to 14 days after date of last dose of elranatamab
measure: Daratumumab pharmacokinetics by pre-dose concentrations
timeFrame: From date of first dose through up to 14 days after date of last dose of daratumumab
measure: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
timeFrame: From date of informed consent through up to 35 days after date of last dose of study intervention
measure: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
timeFrame: From date of informed consent through up to 35 days after date of last dose of study intervention
Other outcomes:
Locations:
city: Clovis
country: United States
facility: Clovis Community Medical Center
state: California
city: Clovis
country: United States
facility: Community Cancer Institute
state: California
city: Fresno
country: United States
facility: University of California San Francisco
state: California
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: Fort Collins
country: United States
facility: UCHealth Poudre Valley Hospital
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Harmony
state: Colorado
city: Greeley
country: United States
facility: UCHealth Greeley Hospital
state: Colorado
city: Loveland
country: United States
facility: UCHealth - Medical Center of the Rockies
state: Colorado
city: Aventura
country: United States
facility: Sylvester Comprehensive Cancer Center - Aventura
state: Florida
city: Coral Gables
country: United States
facility: Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
state: Florida
city: Coral Springs
country: United States
facility: Sylvester Comprehensive Cancer Center - Coral Springs
state: Florida
city: Deerfield Beach
country: United States
facility: University of Miami Hospital and Clinics - Deerfield Beach
state: Florida
city: Hollywood
country: United States
facility: Sylvester Comprehensive Cancer Center - Hollywood
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital And Clinics
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center - Kendall
state: Florida
city: Plantation
country: United States
facility: Sylvester Comprehensive Cancer Center - Plantation
state: Florida
city: Metairie
country: United States
facility: East Jefferson General Hospital Bone Marrow Transplant Clinic
state: Louisiana
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Basking Ridge
country: United States
facility: MSK Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: MSK Monmouth
state: New Jersey
city: Montvale
country: United States
facility: MSK Bergen
state: New Jersey
city: Commack
country: United States
facility: MSK Commack
state: New York
city: Harrison
country: United States
facility: MSK Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - Main Campus
state: New York
city: Uniondale
country: United States
facility: MSK Nassau
state: New York
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: FUNDALEU - Fundacion para combatir la Leucemia
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: FUNDALEU -Fundación para combatir la leucemia
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: FUNDALEU
state: Buenos Aires
city: Derqui
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Buenos Aires
city: Rosario
country: Argentina
facility: Sanatorio de La Mujer
state: Santa FE
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Clayfield
country: Australia
facility: QScan Radiology Clinics
state: Queensland
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Foundation
state: Queensland
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: East Melbourne
country: Australia
facility: Epworth Freemasons
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital (Melbourne)
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Richmond
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Richmond
country: Australia
facility: Slade Pharmacy
state: Victoria
city: Perth
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Krems
country: Austria
facility: Universitätsklinikum Krems
state: Niederösterreich
city: Vienna
country: Austria
facility: Klinik Ottakring
state: Wien
city: Innsbruck
country: Austria
facility: Universitätsklinik für Innere Medizin V Innsbruck
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Gilly
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
city: Yvoir
country: Belgium
facility: CHU UCL Namur (site Godinne)
state: Namur
city: Salvador
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
state: Bahia
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa Clínica - Área Administrativa
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RIO Grande DO SUL
city: Sao Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo
state: SÃO Paulo
city: SP
country: Brazil
facility: Clínica Médica São Germano LTDA
state: SÃO Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Américas Medical City
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educação, Pesquisa e Gestão em Saúde
city: São Paulo
country: Brazil
facility: ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
city: São Paulo
country: Brazil
facility: IDOR Ensino e Pesquisa
city: São Paulo
country: Brazil
facility: HU UNIFESP / SPDM - Hospital São Paulo
city: São Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
city: São Paulo
country: Brazil
facility: Clínica Médica São Germano S/S Ltda
city: São Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
city: São Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Victoria General Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center
state: Saskatchewan
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Tianjin
country: China
facility: Institute of hematology&blood disease hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Boren Hospital
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice
state: Brno-m?sto
city: Plzen - Lochotin
country: Czechia
facility: Fakultni Nemocnice Plzen
state: Plzeňský KRAJ
city: Praha
country: Czechia
facility: Fakultni poliklinika
state: Praha 2
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
state: Pirkanmaa
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala
state: Pohjois-pohjanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala
state: Pohjois-savo
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-suomi
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
state: Limousin
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille
state: Nord
city: Nantes Cedex 1
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
city: Paris Cedex 12
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hopital Necker
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
city: Poitiers Cedex
country: France
facility: CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden-württemberg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig gGmbH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGMbH
city: Muenchen
country: Germany
facility: Universitätsklinikum rechts der Isar, Technische Universität München (TUM)
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attikí
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
state: Attikí
city: Athina
country: Greece
facility: Radiology vendor
state: Attikí
city: Thessaloniki
country: Greece
facility: Theageneio Cancer Hospital of Thessaloniki
state: Kentrikí Makedonía
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Meldola
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
state: Emilia-romagna
city: Genova
country: Italy
facility: Ospedale San Martino
state: Liguria
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: Lombardia
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)
state: Milan
city: Catania
country: Italy
facility: Policlinico "G. Rodolico"
state: Sicilia
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Shibukawa
country: Japan
facility: National Hospital Organization Shibukawa Medical Center
state: Gunma
city: Yahaba-cho
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonranamdo
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [seoul]
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Taegu-kwangyǒkshi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Colonia Valle De Las Palmas
country: Mexico
facility: Hematológica Alta Especialidad SC, consultorio 830
state: México
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo LEÓN
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: Veracruz
country: Mexico
facility: Instituto Veracruzano en Investigación Clínica S.C.
city: Rotterdam
country: Netherlands
facility: Erasmus Universitair Medisch Centrum
state: Zuid-holland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Labtests Auckland Ltd.
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials
city: Hamilton
country: New Zealand
facility: Waikato District Health Board, Waikato Hospital
city: Milford
country: New Zealand
facility: TRG Imaging
city: Newtown
country: New Zealand
facility: Pacific Radiology
city: Palmerston North
country: New Zealand
facility: Broadway Radiology
city: Roslyn
country: New Zealand
facility: Palmerston North Hospital
city: Takapuna
country: New Zealand
facility: Pharmacy on Shakespeare
city: Wellington
country: New Zealand
facility: Capital, Coast and Hutt Valley District - Wellington Regional Hospital
city: Bergen
country: Norway
facility: Haukeland Universitetssjukehus
state: Hordaland
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus
state: Rogaland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Ullevål
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: A Coruna
city: L'Hospitalet Del Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet
state: Barcelona [barcelona]
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
state: Other
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Girona
country: Spain
facility: Hospital Universitari De Girona Doctor Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus Lund
state: Skåne LÄN [se-12]
city: Borås
country: Sweden
facility: Södra Älvsborg Sjukhus
city: Falun
country: Sweden
facility: Falu Lasarett
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Luleå
country: Sweden
facility: Sunderby Sjukhus
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
state: Örebro LÄN [se-18]
city: Linköping
country: Sweden
facility: Läkemedelsberedningen
state: Östergötlands LÄN [se-05]
city: Linköping
country: Sweden
facility: Universitetssjukhuset i Linköping
state: Östergötlands LÄN [se-05]
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
state: İ̇stanbul
city: İstanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi
state: İ̇stanbul
city: Istanbul
country: Turkey
facility: Acibadem Universitesi Atakent Hastanesi
state: İ̇stanbul
city: İstanbul
country: Turkey
facility: Sisli Florence Nightingale Hastanesi
state: İ̇stanbul
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi
state: İ̇zmir
city: İzmir
country: Turkey
facility: Dokuz Eylul Universitesi Hastanesi
state: İ̇zmir
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
city: Ankara
country: Turkey
facility: Ankara University Health Practice and Research Hospitals
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri
city: Kocaeli
country: Turkey
facility: Özel Anadolu Sağlık Merkezi
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tıp Merkezi
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
city: Oxford
country: United Kingdom
facility: Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: South Glamorgan
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: