Spots Global Cancer Trial Database for MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
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Trial Identification
Brief Title: MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
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 ID: NCT05020236
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor 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 compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clovis Community Medical Center, Clovis, California, United States
Community Cancer Institute, Clovis, California, United States
University of California San Francisco, Fresno, California, United States
Community Regional Medical Center, Fresno, California, United States
UCHealth Poudre Valley Hospital, Fort Collins, Colorado, United States
UCHealth Harmony, Fort Collins, Colorado, United States
UCHealth Greeley Hospital, Greeley, Colorado, United States
UCHealth - Medical Center of the Rockies, Loveland, Colorado, United States
Sylvester Comprehensive Cancer Center - Aventura, Aventura, Florida, United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center, Coral Gables, Florida, United States
Sylvester Comprehensive Cancer Center - Coral Springs, Coral Springs, Florida, United States
University of Miami Hospital and Clinics - Deerfield Beach, Deerfield Beach, Florida, United States
Sylvester Comprehensive Cancer Center - Hollywood, Hollywood, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
University of Miami Hospital And Clinics, Miami, Florida, United States
Sylvester Comprehensive Cancer Center - Kendall, Miami, Florida, United States
Sylvester Comprehensive Cancer Center - Plantation, Plantation, Florida, United States
Tulane Cancer Center, New Orleans, Louisiana, United States
Tulane Medical Center, New Orleans, Louisiana, United States
MSK Basking Ridge, Basking Ridge, New Jersey, United States
MSK Monmouth, Middletown, New Jersey, United States
MSK Bergen, Montvale, New Jersey, United States
Christus St. Vincent Regional Cancer Center, Santa Fe, New Mexico, United States
Christus St. Vincent Regional Medical Center, Santa Fe, New Mexico, United States
Santa Fe Imaging, Santa Fe, New Mexico, United States
X-Ray Associates of Santa Fe - XRANM, Santa Fe, New Mexico, United States
MSK Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street)., New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus, New York, New York, United States
MSK Nassau, Uniondale, New York, United States
Baylor University Medical Center, Dallas, Texas, United States
Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming), Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
FUNDALEU - Fundacion para combatir la Leucemia, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
FUNDALEU -Fundación para combatir la leucemia, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
FUNDALEU, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral, Derqui, Pilar, Buenos Aires, Argentina
Hospital Italiano de la Plata, La Plata, Buenos Aires, Argentina
Sanatorio de La Mujer, Rosario, Santa FE, Argentina
Pindara Private Hospital, Benowa, Queensland, Australia
QScan Radiology Clinics, Clayfield, Queensland, Australia
Gallipoli Medical Research Foundation, Greenslopes, Queensland, Australia
Greenslopes Private Hospital, Greenslopes, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Epworth Freemasons, East Melbourne, Victoria, Australia
St Vincent's Hospital (Melbourne), Fitzroy, Victoria, Australia
Barwon Health, Geelong, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Epworth Healthcare, Richmond, Victoria, Australia
Slade Pharmacy, Richmond, Victoria, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
Linear Clinical Research, Perth, Western Australia, Australia
Universitätsklinikum Krems, Krems, Niederösterreich, Austria
Medizinische Universität Wien, Vienna, Wien, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien, Vienna, Wien, Austria
Klinik Ottakring, Vienna, Wien, Austria
Universitätsklinik für Innere Medizin V Innsbruck, Innsbruck, , Austria
Uniklinikum Salzburg, Salzburg, , Austria
Medizinische Universität Wien, Wien, , Austria
Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium
CHU UCL Namur (site Godinne), Yvoir, Namur, Belgium
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador, Salvador,, Bahia, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa, Porto Alegre, RIO Grande DO SUL, Brazil
Centro de Pesquisa Clínica - Área Administrativa, Porto Alegre, RIO Grande DO SUL, Brazil
Hospital Mae de Deus, Porto Alegre, RIO Grande DO SUL, Brazil
Hospital Santa Cruz / Centro de Pesquisa, São Paulo, SP, Brazil
Hospital Américas Medical City, Rio de Janeiro, , Brazil
Instituto de Educação, Pesquisa e Gestão e Saúde, Rio de janeiro, , Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde, Rio de Janeiro, , Brazil
BP - A Beneficencia Portuguesa de São Paulo, Sao Paulo, , Brazil
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis, São Paulo, , Brazil
IDOR Ensino e Pesquisa, São Paulo, , Brazil
HU UNIFESP / SPDM - Hospital São Paulo, São Paulo, , Brazil
Universidade Federal de Sao Paulo, São Paulo, , Brazil
Hospital Japonês Santa Cruz, São Paulo, , Brazil
Clínica Médica São Germano LTDA, São Paulo, , Brazil
Clínica Médica São Germano S/S Ltda, São Paulo, , Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR), São Paulo, , Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR), São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo, , Brazil
Tom Baker Cancer Center, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
QEII Health Sciences Centre - Victoria General Site, Halifax, Nova Scotia, Canada
Queen Elizabeth II Health Science Centre, Halifax, Nova Scotia, Canada
Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal, Montréal, Quebec, Canada
Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada
Peking University Third Hospital, Beijing, Beijing, China
Beijing Peking Union Medical College Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Shenzhen Second People's Hospital, Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jilin Province Cancer Hospital, Changchun, Jilin, China
The First Hospital of Jilin University, Changchun, Jilin, China
Jinan Central Hospital, Jinan, Shandong, China
Shandong Provincial Hospital, Jinan, Shandong, China
Jinan Central Hospital, Jinan, Shandong, China
Institute of hematology&blood disease hospital, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Beijing Boren Hospital, Beijing, , China
Chongqing University Cancer Hospital, Chongqing, , China
Jinan Central Hospital, Jinan, , China
Fakultní nemocnice Brno Bohunice, Brno, Brno-m?sto, Czechia
Fakultni Nemocnice Plzen, Plzen - Lochotin, Plzeňský KRAJ, Czechia
Fakultni poliklinika, Praha, Praha 2, Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava-Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Tampereen yliopistollinen sairaala, Tampere, Pirkanmaa, Finland
Oulun yliopistollinen sairaala, Oulu, Pohjois-pohjanmaa, Finland
Kuopion Yliopistollinen Sairaala, Kuopio, Pohjois-savo, Finland
Turku University Hospital, Turku, Varsinais-suomi, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus), Helsinki, , Finland
Tampereen yliopistollinen sairaala, Tampere, , Finland
CHU Bordeaux Haut-Leveque, Pessac, Aquitaine, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren, Limoges, Limousin, France
Hopital Claude Huriez - CHU de Lille, Lille, Nord, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu, Nantes Cedex 1, , France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu, Nantes, , France
Hôpital Saint Antoine, Paris Cedex 12, , France
Hopital Necker, Paris, , France
Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique, Pierre Benite Cedex, , France
CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie, Poitiers Cedex, , France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE, Toulouse, , France
Universitaetsklinikum Ulm, Ulm, Baden-württemberg, Germany
Universitätsklinikum Würzburg, Würzburg, Bayern, Germany
Universitaetsklinikum Koeln, Köln, Nordrhein-westfalen, Germany
Uniklinik RWTH Aachen, Aachen, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
Staedtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Klinikum Chemnitz gGMbH, Chemnitz, , Germany
St. Barbara-Klinik Hamm-Heessen, Hamm, , Germany
Universitätsklinikum rechts der Isar, Technische Universität München (TUM), Muenchen, , Germany
Klinikum rechts der Isar der Technischen Universität München, München, , Germany
Evangelismos General Hospital of Athens, Athens, Attikí, Greece
Evangelismos Hospital, Athens, Attikí, Greece
Alexandra General Hospital of Athens, Athens, Attikí, Greece
Theageneio Cancer Hospital of Thessaloniki, Thessaloniki, Kentrikí Makedonía, Greece
Radiology vendor, Athens, , Greece
University General Hospital of Ioannina, Ioannina, , Greece
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Emilia-romagna, Italy
Ospedale San Martino, Genova, Liguria, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, Lombardia, Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, Italy
ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra), Milano, Milan, Italy
Policlinico "G. Rodolico", Catania, Sicilia, Italy
Azienda Ospedaliero Universitaria Senese, Siena, Toscana, Italy
IRCCS - AOU di Bologna, Bologna, , Italy
AOU Policlinico Umberto I, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
Nagoya City University Hospital, Nagoya, Aichi, Japan
Toyohashi Municipal Hospital, Toyohashi, Aichi, Japan
University of Fukui Hospital, Yoshida-gun, Fukui, Japan
National Hospital Organization Shibukawa Medical Center, Shibukawa, Gunma, Japan
Iwate Medical University Hospital, Yahaba-cho, Shiwa-gun, Iwate, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Hamamatsu University Hospital, Hamamatsu, Shizuoka, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan
Akita University Hospital, Akita, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Kagoshima University Hospital, Kagoshima, , Japan
National Hospital Organization Kumamoto Medical Center, Kumamoto, , Japan
Nagasaki University Hospital, Nagasaki, , Japan
National Hospital Organization Okayama Medical Center, Okayama, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Tokushima University Hospital, Tokushima, , Japan
Yamagata University Hospital, Yamagata, , Japan
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, Jeonranamdo, Korea, Republic of
Pusan National University Hospital, Busan, Pusan-kwangyǒkshi, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Kyungpook National University Hospital, Daegu, Taegu-kwangyǒkshi, Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Hematológica Alta Especialidad SC, consultorio 830, Colonia Valle De Las Palmas, Huixquilucan, México, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo LEÓN, Mexico
Centro de Investigacion Clinica de Oaxaca, Oaxaca, , Mexico
Instituto Veracruzano en Investigación Clínica S.C., Veracruz, , Mexico
Erasmus Universitair Medisch Centrum, Rotterdam, Zuid-holland, Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
North Shore Hospital, Auckland, , New Zealand
North Shore Hospital, Auckland, , New Zealand
Aotearoa Clinical Trials, Auckland, , New Zealand
Middlemore Clinical Trials, Auckland, , New Zealand
Waikato District Health Board, Waikato Hospital, Hamilton, , New Zealand
Pacific Radiology, Newtown, Wellington, , New Zealand
Broadway Radiology, Palmerston North, , New Zealand
Palmerston North Hospital, Roslyn, , New Zealand
Pharmacy on Shakespeare, Takapuna, Auckland, , New Zealand
Capital, Coast and Hutt Valley District - Wellington Regional Hospital, Wellington, , New Zealand
Haukeland Universitetssjukehus, Bergen, Hordaland, Norway
Stavanger Universitetssykehus, Stavanger, Rogaland, Norway
Oslo Universitetssykehus Ullevål, Oslo, , Norway
St Olavs Hospital, Trondheim, , Norway
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii, Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy, Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Pratia Onkologia Katowice, Katowice, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, , Poland
Centrum Medyczne Pratia Poznan, Skorzewo, , Poland
Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny, Warszawa, , Poland
Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku, Wroclaw, , Poland
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruna, Spain
Institut Català d'Oncologia - L'Hospitalet, L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain
Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain
Hospital Universitario Mutua Terrassa, Terrassa, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Clinica Universidad de Navarra, Madrid, Madrid, Comunidad DE, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario de Toledo, Toledo, Other, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital Universitario Reina Sofía, Cordoba, , Spain
Hospital Universitari De Girona Doctor Josep Trueta, Girona, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital Universitario Madrid Sanchinarro, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital Universitario y Politecnico La Fe, Valencia, , Spain
Helsingborgs Lasarett, Helsingborg, Skåne LÄN [se-12], Sweden
Skånes Universitetssjukhus Lund, Lund, Skåne LÄN [se-12], Sweden
Södra Älvsborg Sjukhus, Borås, , Sweden
Falu Lasarett, Falun, , Sweden
Sahlgrenska Universitetssjukhuset, Göteborg, , Sweden
Sunderby Sjukhus, Luleå, , Sweden
Universitetssjukhuset Örebro, Örebro, Örebro LÄN [se-18], Sweden
Universitetssjukhuset i Linköping, Linköping, Östergötlands LÄN [se-05], Sweden
Chang Gung Memorial Hospital at Kaohsiung, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Sisli Florence Nightingale Hastanesi, İstanbul / Şişli, İ̇stanbul, Turkey
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi, Istanbul, İ̇stanbul, Turkey
Medipol Mega Universite Hastanesi, İstanbul, İ̇stanbul, Turkey
Acibadem Universitesi Atakent Hastanesi, Istanbul, İ̇stanbul, Turkey
Ege Universitesi Hastanesi, İzmir, İ̇zmir, Turkey
Dokuz Eylul Universitesi Hastanesi, İzmir, İ̇zmir, Turkey
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi, Adana, , Turkey
Ankara Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi, Ankara, , Turkey
Akdeniz Universitesi Hastanesi, Antalya, , Turkey
Aydın Adnan Menderes Universitesi Hastanesi, Aydin, , Turkey
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi, Gaziantep, , Turkey
Erciyes Universitesi Tıp Fakultesi Hastaneleri, Kayseri, , Turkey
Özel Anadolu Sağlık Merkezi, Kocaeli, , Turkey
Inonu Universitesi Turgut Ozal Tıp Merkezi, Malatya, , Turkey
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, United Kingdom
Churchill Hospital, Oxford, Oxfordshire, United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Headington, Oxford, United Kingdom
University Hospital of Wales, Cardiff, South Glamorgan, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Kent and Canterbury Hospital, Canterbury, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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