A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
MAGNETISMM-5
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
4 other identifiers
interventional
893
25 countries
232
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Oct 2021
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
ExpectedAugust 24, 2026
August 1, 2026
4.4 years
August 11, 2021
August 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part 1 Safety Lead-In: Incidence of dose limiting toxicities
First 42 days after first elranatamab dose
Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Part 3: Frequency of treatment-emergent adverse events
First 84 days after first elranatamab dose
Secondary Outcomes (18)
Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Overall survival
From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Objective response rate per International Myeloma Working Group criteria
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
Duration of response per International Myeloma Working Group criteria
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
Time to response per International Myeloma Working Group criteria
From date of randomization to date of confirmed objective response, assessed up to 51 months
- +13 more secondary outcomes
Study Arms (6)
Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
EXPERIMENTALPart 2 Randomized Arm A: Elranatamab
EXPERIMENTALPart 2 Randomized Arm B: Elranatamab + Daratumumab
EXPERIMENTALPart 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
ACTIVE COMPARATORPart 3 Arm D: Elranatamab
EXPERIMENTALPart 3 Arm E: Elranatamab + Daratumumab
EXPERIMENTALInterventions
subcutaneous
Daratumumab / hyaluronidase, subcutaneous
oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (237)
Clovis Community Medical Center
Clovis, California, 93611, United States
Community Cancer Institute
Clovis, California, 93611, United States
University of California San Francisco
Fresno, California, 93701, United States
Community Regional Medical Center
Fresno, California, 93721, United States
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
UCHealth Harmony
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80634, United States
UCHealth - Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Sylvester Comprehensive Cancer Center - Aventura
Aventura, Florida, 33180, United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, 33146, United States
Sylvester Comprehensive Cancer Center - Coral Springs
Coral Springs, Florida, 33065, United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, 33021, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
Sylvester Comprehensive Cancer Center - Kendall
Miami, Florida, 33176, United States
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, 33324, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
MSK Basking Ridge
Basking Ridge, New Jersey, 07920, United States
MSK Monmouth
Middletown, New Jersey, 07748, United States
MSK Bergen
Montvale, New Jersey, 07645, United States
MSK Commack
Commack, New York, 11725, United States
MSK Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065, United States
MSK Nassau
Uniondale, New York, 11553, United States
Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426, Argentina
FUNDALEU - Fundacion para combatir la Leucemia
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1114AAN, Argentina
FUNDALEU -Fundación para combatir la leucemia
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1114AAP, Argentina
FUNDALEU
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1114AAP, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900XI, Argentina
Hospital Universitario Austral
Presidente Derqui, Buenos Aires, B1629AHJ, Argentina
Sanatorio de La Mujer
Rosario, Santa Fe Province, S2000ORE, Argentina
Pindara Private Hospital
Benowa, Queensland, 4217, Australia
QScan Radiology Clinics
Clayfield, Queensland, 4011, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, 4120, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, 4120, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Epworth Freemasons
East Melbourne, Victoria, 3002, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Epworth Healthcare
Richmond, Victoria, 3121, Australia
Slade Pharmacy
Richmond, Victoria, 3121, Australia
Linear Clinical Research
Perth, Western Australia, 6009, Australia
Universitätsklinikum Krems
Krems, Lower Austria, 3500, Austria
Klinik Ottakring
Vienna, State of Vienna, 1160, Austria
Universitätsklinik für Innere Medizin V Innsbruck
Innsbruck, 6020, Austria
Uniklinikum Salzburg
Salzburg, 5020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Grand Hôpital de Charleroi
Gilly, Hainaut, 6060, Belgium
CHU UCL Namur (site Godinne)
Yvoir, Namur, 5530, Belgium
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, Estado de Bahia, 41253-190, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Centro de Pesquisa Clínica - Área Administrativa
Porto Alegre, Rio Grande do Sul, 90850-170, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
BP - A Beneficencia Portuguesa de São Paulo
São Paulo, São Paulo, 01321-001, Brazil
Clínica Médica São Germano LTDA
SP, São Paulo, 04537-080, Brazil
Hospital Américas Medical City
Rio de Janeiro, 22775001, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, 22793-080, Brazil
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
São Paulo, 01232-010, Brazil
IDOR Ensino e Pesquisa
São Paulo, 01401-002., Brazil
HU UNIFESP / SPDM - Hospital São Paulo
São Paulo, 04024-002, Brazil
Universidade Federal de Sao Paulo
São Paulo, 04024-002, Brazil
Clínica Médica São Germano S/S Ltda
São Paulo, 04537-080, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04543-000, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04544-000, Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, L8V5C2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T2M4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Saskatoon Cancer Center
Saskatoon, Saskatchewan, S7N4H4, Canada
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510555, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Province Cancer Hospital
Changchun, Jilin, 130000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Jinan Central Hospital
Jinan, Shandong, 250100, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, 301636, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Beijing Boren Hospital
Beijing, 100070, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, 100730, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Fakultní nemocnice Brno Bohunice
Brno, Brno-m?sto, 625 00, Czechia
Fakultni Nemocnice Plzen
Plzen - Lochotin, Plzeň Region, 304 60, Czechia
Fakultni poliklinika
Prague, Praha 2, 120 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, 708 52, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, 70210, Finland
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520, Finland
Turku University Hospital
Turku, Southwest Finland, 20520, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, 00029, Finland
Oulun yliopistollinen sairaala
Oulu, 90220, Finland
Tampereen yliopistollinen sairaala
Tampere, 33520, Finland
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, Limousin, 87042, France
Hopital Claude Huriez - CHU de Lille
Lille, NORD, 59000, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, 44093, France
Hopital Necker
Paris, 75015, France
Hôpital Saint Antoine
Paris, 75571, France
Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
Pierre-Bénite, 69495, France
CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie
Poitiers, 86021, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, 31059, France
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Charité Universitätsmedizin Berlin
Berlin, 12203, Germany
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig, 38114, Germany
Klinikum Chemnitz gGMbH
Chemnitz, 09116, Germany
Universitätsklinikum rechts der Isar, Technische Universität München (TUM)
München, 81675, Germany
Evangelismos General Hospital of Athens
Athens, Attikí, 106 76, Greece
Radiology vendor
Athens, Attikí, 115 25, Greece
Alexandra General Hospital of Athens
Athens, Attikí, 115 28, Greece
Theageneio Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, 546 39, Greece
University General Hospital of Ioannina
Ioannina, Greece
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, 47014, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, 20900, Italy
ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)
Milan, Milan, 20153, Italy
Policlinico "G. Rodolico"
Catania, Sicily, 95123, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)
Genova, 16132, Italy
AOU Policlinico Umberto I
Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa, Gunma, 377-0280, Japan
Iwate Medical University Hospital
Yahaba-cho, Iwate, 028-3695, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935, Japan
Akita University Hospital
Akita, 010-8543, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Hematológica Alta Especialidad SC, consultorio 830
Colonia Valle de Las Palmas, México, 52787, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020, Mexico
Instituto Veracruzano en Investigación Clínica S.C.
Veracruz, 91851, Mexico
Erasmus Universitair Medisch Centrum
Rotterdam, South Holland, 3015 GD, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
North Shore Hospital
Auckland, 0622, New Zealand
Labtests Auckland Ltd.
Auckland, 1060, New Zealand
Aotearoa Clinical Trials
Auckland, 2025, New Zealand
Waikato District Health Board, Waikato Hospital
Hamilton, 3204, New Zealand
TRG Imaging
Milford, 0620, New Zealand
Pacific Radiology
Newtown, 6021, New Zealand
Broadway Radiology
Palmerston North, 4410, New Zealand
Palmerston North Hospital
Roslyn, 4414, New Zealand
Pharmacy on Shakespeare
Takapuna, 0620, New Zealand
Capital, Coast and Hutt Valley District - Wellington Regional Hospital
Wellington, 6021, New Zealand
Haukeland Universitetssjukehus
Bergen, Hordaland, 5021, Norway
Stavanger Universitetssykehus
Stavanger, Rogaland, 4021, Norway
Oslo Universitetssykehus Ullevål
Oslo, 0450, Norway
St Olavs Hospital
Trondheim, 7030, Norway
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii
Bydgoszcz, 85-168, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, 60-185, Poland
Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
Warsaw, 02-097, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-367, Poland
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo, 58128, South Korea
Pusan National University Hospital
Busan, Pusan-kwangyǒkshi, 49241, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], 06591, South Korea
Kyungpook National University Hospital
Daegu, Taegu-kwangyǒkshi, 41944, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruna, 15706, Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona [barcelona], 08908, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario de Toledo
Toledo, Other, 45007, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic Barcelona
Barcelona, 08036, Spain
Hospital Universitari De Girona Doctor Josep Trueta
Girona, 17007, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Skånes Universitetssjukhus Lund
Lund, Skåne LÄN [se-12], 22185, Sweden
Södra Älvsborg Sjukhus
Borås, 501 82, Sweden
Falu Lasarett
Falun, 791 82, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345, Sweden
Sunderby Sjukhus
Luleå, 971 80, Sweden
Universitetssjukhuset Örebro
Örebro, Örebro LÄN [se-18], 701 85, Sweden
Läkemedelsberedningen
Linköping, Östergötlands LÄN [se-05], 581 85, Sweden
Universitetssjukhuset i Linköping
Linköping, Östergötlands LÄN [se-05], 581 85, Sweden
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 83301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
Istanbul, İ̇stanbul, 34093, Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul, İ̇stanbul, 34214, Turkey (Türkiye)
Acibadem Universitesi Atakent Hastanesi
Istanbul, İ̇stanbul, 34303, Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, İ̇zmir, 35100, Turkey (Türkiye)
Dokuz Eylul Universitesi Hastanesi
Izmir, İ̇zmir, 35340, Turkey (Türkiye)
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, 01240, Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, 06100, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, 06200, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi
Antalya, 07070, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Sisli Florence Nightingale Hastanesi
Istanbul, 34381, Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri
Kayseri, 38030, Turkey (Türkiye)
Özel Anadolu Sağlık Merkezi
Kocaeli, 41400, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tıp Merkezi
Malatya, 44280, Turkey (Türkiye)
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE, United Kingdom
University Hospital of Wales
Cardiff, South Glamorgan, CF14 4XW, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 25, 2021
Study Start
October 4, 2021
Primary Completion
February 26, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
August 24, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.