MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab; Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 762
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1426
      • Active, not recruiting
      • Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1114AAN
      • Active, not recruiting
      • FUNDALEU - Fundacion para combatir la Leucemia
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1114AAP
      • Active, not recruiting
      • FUNDALEU -Fundación para combatir la leucemia
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1114AAP
      • Active, not recruiting
      • Fundaleu
    • Derqui, Pilar, Buenos Aires, Argentina, B1629AHJ
      • Active, not recruiting
      • Hospital Universitario Austral
    • La Plata, Buenos Aires, Argentina, B1900XI
      • Active, not recruiting
      • Hospital Italiano de la Plata
  • Santa FE
    • Rosario, Santa FE, Argentina, S2000ORE
      • Active, not recruiting
      • Sanatorio de La Mujer
• Australia
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Active, not recruiting
      • Pindara Private Hospital
    • Clayfield, Queensland, Australia, 4011
      • Active, not recruiting
      • QScan Radiology Clinics
    • Greenslopes, Queensland, Australia, 4120
      • Active, not recruiting
      • Gallipoli Medical Research Foundation
    • Greenslopes, Queensland, Australia, 4120
      • Active, not recruiting
      • Greenslopes Private Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Active, not recruiting
      • Princess Alexandra Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Active, not recruiting
      • Epworth Freemasons
    • Fitzroy, Victoria, Australia, 3065
      • Active, not recruiting
      • St Vincent's Hospital (Melbourne)
    • Geelong, Victoria, Australia, 3220
      • Active, not recruiting
      • Barwon Health
    • Melbourne, Victoria, Australia, 3004
      • Active, not recruiting
      • The Alfred Hospital
    • Richmond, Victoria, Australia, 3121
      • Active, not recruiting
      • Epworth Healthcare
    • Richmond, Victoria, Australia, 3121
      • Active, not recruiting
      • Slade Pharmacy
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Active, not recruiting
      • Linear Clinical Research
    • Perth, Western Australia, Australia, 6009
      • Active, not recruiting
      • Linear Clinical Research
• Austria
  • Innsbruck, Austria, 6020
    • Active, not recruiting
    • Universitätsklinik für Innere Medizin V Innsbruck
  • Salzburg, Austria, 5020
    • Active, not recruiting
    • Uniklinikum Salzburg
  • Wien, Austria, 1090
    • Active, not recruiting
    • Medizinische Universität Wien
  • Niederösterreich
    • Krems, Niederösterreich, Austria, 3500
      • Active, not recruiting
      • Universitätsklinikum Krems
  • Wien
    • Vienna, Wien, Austria, 1090
      • Active, not recruiting
      • Medizinische Universität Wien
    • Vienna, Wien, Austria, 1160
      • Active, not recruiting
      • Klinik Ottakring
    • Vienna, Wien, Austria, 1090
      • Active, not recruiting
      • Universitaetsklinikum Allgemeines Krankenhaus Wien
• Belgium
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Active, not recruiting
      • Grand Hôpital de Charleroi
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Active, not recruiting
      • CHU UCL Namur (Site Godinne)
• Brazil
  • Rio de Janeiro, Brazil, 22775001
    • Active, not recruiting
    • Hospital Américas Medical City
  • Rio de Janeiro, Brazil, 22793-080
    • Active, not recruiting
    • Instituto de Educação, Pesquisa e Gestão em Saúde
  • Rio de janeiro, Brazil, 22793-080
    • Active, not recruiting
    • Instituto de Educação, Pesquisa e Gestão e Saúde
  • Sao Paulo, Brazil, 01321-001
    • Active, not recruiting
    • BP - A Beneficencia Portuguesa de São Paulo
  • São Paulo, Brazil, 01232-010
    • Active, not recruiting
    • ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
  • São Paulo, Brazil, 01401-002.
    • Active, not recruiting
    • IDOR Ensino e Pesquisa
  • São Paulo, Brazil, 04024-002
    • Active, not recruiting
    • HU UNIFESP / SPDM - Hospital São Paulo
  • São Paulo, Brazil, 04024-002
    • Active, not recruiting
    • Universidade Federal de Sao Paulo
  • São Paulo, Brazil, 04537-080
    • Active, not recruiting
    • Clínica Médica São Germano S/S Ltda
  • São Paulo, Brazil, 04543-000
    • Active, not recruiting
    • Instituto D'Or de Pesquisa e Ensino (IDOR)
  • São Paulo, Brazil, 04544-000
    • Active, not recruiting
    • Instituto D'Or de Pesquisa e Ensino (IDOR)
  • São Paulo, Brazil, 05652-900
    • Active, not recruiting
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 04122-000
    • Active, not recruiting
    • Hospital Japonês Santa Cruz
  • São Paulo, Brazil, 04537-080
    • Active, not recruiting
    • Clínica Médica São Germano LTDA
  • Bahia
    • Salvador,, Bahia, Brazil, 41253-190
      • Active, not recruiting
      • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90110-270
      • Active, not recruiting
      • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90850-170
      • Active, not recruiting
      • Centro de Pesquisa Clínica - Área Administrativa
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90880-480
      • Active, not recruiting
      • Hospital Mae de Deus
  • SP
    • São Paulo, SP, Brazil, 04122-000
      • Active, not recruiting
      • Hospital Santa Cruz / Centro de Pesquisa
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Active, not recruiting
      • Tom Baker Cancer Center
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Active, not recruiting
      • Cross Cancer Institute
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Active, not recruiting
      • QEII Health Sciences Centre - Victoria General Site
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Active, not recruiting
      • Queen Elizabeth II Health Science Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V5C2
      • Active, not recruiting
      • Hamilton Health Sciences-Juravinski Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Active, not recruiting
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Active, not recruiting
      • Jewish General Hospital
    • Montréal, Quebec, Canada, H1T2M4
      • Active, not recruiting
      • CIUSSS de l'Est-de-l'Île-de-Montréal
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N4H4
      • Active, not recruiting
      • Saskatoon Cancer Center
• China
  • Beijing, China, 100070
    • Recruiting
    • Beijing Boren Hospital
  • Chongqing, China, 400030
    • Recruiting
    • Chongqing University Cancer Hospital
  • Jinan, China, 250100
    • Recruiting
    • Jinan Central Hospital
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Peking Union Medical College Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510555
      • Recruiting
      • Sun Yat-sen University Cancer Center
    • Shenzhen, Guangdong, China, 518035
      • Recruiting
      • Shenzhen Second People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
    • Xuzhou, Jiangsu, China, 221006
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130000
      • Recruiting
      • Jilin Province Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital
    • Jinan, Shandong, China, 250013
      • Not yet recruiting
      • Jinan Central Hospital
    • Jinan, Shandong, China, 250100
      • Recruiting
      • Jinan Central Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China, 300020
      • Recruiting
      • Institute of hematology&blood disease hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Active, not recruiting
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 779 00
    • Active, not recruiting
    • Fakultni nemocnice Olomouc
  • Ostrava-Poruba, Czechia, 708 52
    • Active, not recruiting
    • Fakultni nemocnice Ostrava
  • Praha 2, Czechia, 12808
    • Active, not recruiting
    • Vseobecna fakultni nemocnice v Praze
  • Brno-m?sto
    • Brno, Brno-m?sto, Czechia, 625 00
      • Active, not recruiting
      • Fakultní nemocnice Brno Bohunice
  • Plzeňský KRAJ
    • Plzen - Lochotin, Plzeňský KRAJ, Czechia, 304 60
      • Active, not recruiting
      • Fakultni nemocnice Plzen
  • Praha 2
    • Praha, Praha 2, Czechia, 120 00
      • Active, not recruiting
      • Fakultni poliklinika
• Finland
  • Helsinki, Finland, 00029
    • Active, not recruiting
    • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
  • Tampere, Finland, 33520
    • Active, not recruiting
    • Tampereen yliopistollinen sairaala
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Active, not recruiting
      • Tampereen yliopistollinen sairaala
  • Pohjois-pohjanmaa
    • Oulu, Pohjois-pohjanmaa, Finland, 90220
      • Active, not recruiting
      • Oulun Yliopistollinen sairaala
  • Pohjois-savo
    • Kuopio, Pohjois-savo, Finland, 70210
      • Active, not recruiting
      • Kuopion yliopistollinen sairaala
  • Varsinais-suomi
    • Turku, Varsinais-suomi, Finland, 20520
      • Active, not recruiting
      • Turku University Hospital
• France
  • Nantes, France, 44093
    • Active, not recruiting
    • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
  • Nantes Cedex 1, France, 44093
    • Active, not recruiting
    • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
  • Paris, France, 75015
    • Active, not recruiting
    • Hopital Necker
  • Paris Cedex 12, France, 75571
    • Active, not recruiting
    • Hôpital Saint Antoine
  • Pierre Benite Cedex, France, 69495
    • Active, not recruiting
    • Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
  • Poitiers Cedex, France, 86021
    • Active, not recruiting
    • CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie
  • Toulouse, France, 31059
    • Active, not recruiting
    • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
  • Aquitaine
    • Pessac, Aquitaine, France, 33600
      • Active, not recruiting
      • CHU Bordeaux Haut-Leveque
  • Limousin
    • Limoges, Limousin, France, 87042
      • Active, not recruiting
      • Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
  • Nord
    • Lille, Nord, France, 59000
      • Active, not recruiting
      • Hopital Claude Huriez - CHU de Lille
• Germany
  • Aachen, Germany, 52074
    • Active, not recruiting
    • Uniklinik RWTH Aachen
  • Berlin, Germany, 12200
    • Active, not recruiting
    • Charite Universitätsmedizin Berlin
  • Braunschweig, Germany, 38114
    • Active, not recruiting
    • Staedtisches Klinikum Braunschweig gGmbH
  • Chemnitz, Germany, 09116
    • Active, not recruiting
    • Klinikum Chemnitz gGmbH
  • Hamm, Germany, 59073
    • Active, not recruiting
    • St. Barbara-Klinik Hamm-Heessen
  • Muenchen, Germany, 81675
    • Active, not recruiting
    • Universitätsklinikum rechts der Isar, Technische Universität München (TUM)
  • München, Germany, 81675
    • Active, not recruiting
    • Klinikum rechts der Isar der Technischen Universität München
  • Baden-württemberg
    • Ulm, Baden-württemberg, Germany, 89081
      • Active, not recruiting
      • Universitaetsklinikum Ulm
  • Bayern
    • Würzburg, Bayern, Germany, 97080
      • Active, not recruiting
      • Universitätsklinikum Würzburg
  • Nordrhein-westfalen
    • Köln, Nordrhein-westfalen, Germany, 50937
      • Active, not recruiting
      • Universitaetsklinikum Koeln
• Greece
  • Athens, Greece, 115 25
    • Active, not recruiting
    • Radiology vendor
  • Ioannina, Greece
    • Active, not recruiting
    • University General Hospital of Ioannina
  • Attikí
    • Athens, Attikí, Greece, 106 76
      • Active, not recruiting
      • Evangelismos General Hospital of Athens
    • Athens, Attikí, Greece, 115 28
      • Active, not recruiting
      • Alexandra General Hospital of Athens
    • Athens, Attikí, Greece, 106 76
      • Active, not recruiting
      • Evangelismos Hospital
  • Kentrikí Makedonía
    • Thessaloniki, Kentrikí Makedonía, Greece, 546 39
      • Active, not recruiting
      • Theageneio Cancer Hospital of Thessaloniki
• Italy
  • Bologna, Italy, 40138
    • Active, not recruiting
    • IRCCS - AOU di Bologna
  • Roma, Italy, 00161
    • Active, not recruiting
    • AOU Policlinico Umberto I
  • Roma, Italy, 00168
    • Active, not recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli
  • Emilia-romagna
    • Meldola, Emilia-romagna, Italy, 47014
      • Active, not recruiting
      • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Active, not recruiting
      • Ospedale San Martino
  • Lombardia
    • Milano, Lombardia, Italy, 20122
      • Active, not recruiting
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
    • Monza, Lombardia, Italy, 20900
      • Active, not recruiting
      • Fondazione IRCCS San Gerardo dei Tintori
  • Milan
    • Milano, Milan, Italy, 20153
      • Active, not recruiting
      • ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • Active, not recruiting
      • Policlinico "G. Rodolico"
  • Toscana
    • Siena, Toscana, Italy, 53100
      • Active, not recruiting
      • Azienda Ospedaliero Universitaria Senese
• Japan
  • Akita, Japan, 010-8543
    • Active, not recruiting
    • Akita University Hospital
  • Fukuoka, Japan, 811-1395
    • Active, not recruiting
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Japan, 812-8582
    • Active, not recruiting
    • Kyushu University Hospital
  • Kagoshima, Japan, 890-8520
    • Active, not recruiting
    • Kagoshima University Hospital
  • Kumamoto, Japan, 860-0008
    • Active, not recruiting
    • National Hospital Organization Kumamoto Medical Center
  • Nagasaki, Japan, 852-8501
    • Active, not recruiting
    • Nagasaki University Hospital
  • Okayama, Japan, 701-1192
    • Active, not recruiting
    • National Hospital Organization Okayama Medical Center
  • Osaka, Japan, 545-8586
    • Active, not recruiting
    • Osaka Metropolitan University Hospital
  • Tokushima, Japan, 770-8503
    • Active, not recruiting
    • Tokushima University Hospital
  • Yamagata, Japan, 990-9585
    • Active, not recruiting
    • Yamagata University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 467-8602
      • Active, not recruiting
      • Nagoya City University Hospital
    • Toyohashi, Aichi, Japan, 441-8570
      • Active, not recruiting
      • Toyohashi Municipal Hospital
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1193
      • Active, not recruiting
      • University of Fukui Hospital
  • Gunma
    • Shibukawa, Gunma, Japan, 377-0280
      • Active, not recruiting
      • National Hospital Organization Shibukawa Medical Center
  • Iwate
    • Yahaba-cho, Shiwa-gun, Iwate, Japan, 028-3695
      • Active, not recruiting
      • Iwate Medical University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Active, not recruiting
      • Tohoku University Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Active, not recruiting
      • Hamamatsu University Hospital
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Active, not recruiting
      • Shizuoka Cancer Center
  • Tokyo
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Active, not recruiting
      • Japanese Red Cross Medical Center
• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Active, not recruiting
    • Kyungpook National University Hospital
  • Incheon, Korea, Republic of, 21565
    • Active, not recruiting
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 05505
    • Active, not recruiting
    • Asan Medical Center
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Active, not recruiting
      • Seoul National University Bundang Hospital
  • Jeonranamdo
    • Hwasun-gun, Jeonranamdo, Korea, Republic of, 58128
      • Active, not recruiting
      • Chonnam National University Hwasun Hospital
  • Pusan-kwangyǒkshi
    • Busan, Pusan-kwangyǒkshi, Korea, Republic of, 49241
      • Active, not recruiting
      • Pusan National University Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06351
      • Active, not recruiting
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03080
      • Active, not recruiting
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06591
      • Active, not recruiting
      • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Taegu-kwangyǒkshi
    • Daegu, Taegu-kwangyǒkshi, Korea, Republic of, 41944
      • Active, not recruiting
      • Kyungpook National University Hospital
• Mexico
  • Oaxaca, Mexico, 68020
    • Active, not recruiting
    • Centro de Investigacion Clinica de Oaxaca
  • Veracruz, Mexico, 91851
    • Active, not recruiting
    • Instituto Veracruzano en Investigación Clínica S.C.
  • México
    • Colonia Valle De Las Palmas, Huixquilucan, México, Mexico, 52787
      • Active, not recruiting
      • Hematológica Alta Especialidad SC, consultorio 830
  • Nuevo LEÓN
    • Monterrey, Nuevo LEÓN, Mexico, 66460
      • Active, not recruiting
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Active, not recruiting
    • Maastricht University Medical Center
  • Zuid-holland
    • Rotterdam, Zuid-holland, Netherlands, 3015 GD
      • Active, not recruiting
      • Erasmus Universitair Medisch Centrum
• New Zealand
  • Auckland, New Zealand, 0622
    • Active, not recruiting
    • North Shore Hospital
  • Auckland, New Zealand, 2025
    • Active, not recruiting
    • Aotearoa Clinical Trials
  • Auckland, New Zealand, 0620
    • Active, not recruiting
    • North Shore Hospital
  • Auckland, New Zealand, 2025
    • Active, not recruiting
    • Middlemore Clinical Trials
  • Hamilton, New Zealand, 3204
    • Active, not recruiting
    • Waikato District Health Board, Waikato Hospital
  • Newtown, Wellington, New Zealand, 6021
    • Active, not recruiting
    • Pacific Radiology
  • Palmerston North, New Zealand, 4410
    • Active, not recruiting
    • Broadway Radiology
  • Roslyn, New Zealand, 4414
    • Active, not recruiting
    • Palmerston North Hospital
  • Takapuna, Auckland, New Zealand, 0620
    • Active, not recruiting
    • Pharmacy on Shakespeare
  • Wellington, New Zealand, 6021
    • Active, not recruiting
    • Capital, Coast and Hutt Valley District - Wellington Regional Hospital
• Norway
  • Oslo, Norway, 0450
    • Active, not recruiting
    • Oslo Universitetssykehus Ullevål
  • Trondheim, Norway, 7030
    • Active, not recruiting
    • St Olavs Hospital
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Active, not recruiting
      • Haukeland Universitetssjukehus
  • Rogaland
    • Stavanger, Rogaland, Norway, 4011
      • Active, not recruiting
      • Stavanger Universitetssykehus
• Poland
  • Bydgoszcz, Poland, 85-168
    • Active, not recruiting
    • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii
  • Bydgoszcz, Poland, 85-168
    • Active, not recruiting
    • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Gdansk, Poland, 80-214
    • Active, not recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Katowice, Poland, 40-519
    • Active, not recruiting
    • Pratia Onkologia Katowice
  • Poznan, Poland, 60-569
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny W Poznaniu
  • Skorzewo, Poland, 60-185
    • Active, not recruiting
    • Centrum Medyczne Pratia Poznan
  • Warszawa, Poland, 02-097
    • Active, not recruiting
    • Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
  • Wroclaw, Poland, 50-367
    • Active, not recruiting
    • Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
• Spain
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08036
    • Active, not recruiting
    • Hospital Clinic Barcelona
  • Cordoba, Spain, 14004
    • Active, not recruiting
    • Hospital Universitario Reina Sofia
  • Girona, Spain, 17007
    • Active, not recruiting
    • Hospital Universitari de Girona Doctor Josep Trueta
  • Madrid, Spain, 28006
    • Active, not recruiting
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28050
    • Active, not recruiting
    • Hospital Universitario Madrid Sanchinarro
  • Salamanca, Spain, 37007
    • Active, not recruiting
    • Hospital Universitario de Salamanca
  • Sevilla, Spain, 41013
    • Active, not recruiting
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain, 46026
    • Active, not recruiting
    • Hospital Universitario y Politecnico La Fe
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Active, not recruiting
      • Complejo Hospitalario Universitario de Santiago
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • Active, not recruiting
      • Hospital Universitario Mútua Terrassa
    • Terrassa, Barcelona, Spain, 08221
      • Active, not recruiting
      • Hospital Universitari Mutua Terrassa
  • Barcelona [barcelona]
    • L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain, 08908
      • Active, not recruiting
      • Institut Català d'Oncologia - L'Hospitalet
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Active, not recruiting
      • Hospital Universitario Marqués de Valdecilla
  • Madrid, Comunidad DE
    • Madrid, Madrid, Comunidad DE, Spain, 28027
      • Active, not recruiting
      • Clinica Universidad de Navarra
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Active, not recruiting
      • Clinica Universidad de Navarra
  • Other
    • Toledo, Other, Spain, 45007
      • Active, not recruiting
      • Hospital Universitario de Toledo
• Sweden
  • Borås, Sweden, 501 82
    • Active, not recruiting
    • Södra Älvsborg Sjukhus
  • Falun, Sweden, 791 82
    • Active, not recruiting
    • Falu Lasarett
  • Göteborg, Sweden, 41345
    • Active, not recruiting
    • Sahlgrenska Universitetssjukhuset
  • Luleå, Sweden, 971 80
    • Active, not recruiting
    • Sunderby Sjukhus
  • Skåne LÄN [se-12]
    • Helsingborg, Skåne LÄN [se-12], Sweden, 251 87
      • Active, not recruiting
      • Helsingborgs Lasarett
    • Lund, Skåne LÄN [se-12], Sweden, 22185
      • Active, not recruiting
      • Skånes Universitetssjukhus Lund
  • Örebro LÄN [se-18]
    • Örebro, Örebro LÄN [se-18], Sweden, 701 85
      • Active, not recruiting
      • Universitetssjukhuset Örebro
  • Östergötlands LÄN [se-05]
    • Linköping, Östergötlands LÄN [se-05], Sweden, 581 85
      • Active, not recruiting
      • Universitetssjukhuset i Linköping
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Active, not recruiting
    • Chang Gung Memorial Hospital at Kaohsiung
  • Taichung, Taiwan, 40447
    • Active, not recruiting
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • Active, not recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Active, not recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10002
    • Active, not recruiting
    • National Taiwan University Hospital
• Turkey
  • Adana, Turkey, 01240
    • Active, not recruiting
    • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
  • Ankara, Turkey, 06100
    • Active, not recruiting
    • Ankara Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 06200
    • Active, not recruiting
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
  • Antalya, Turkey, 07070
    • Active, not recruiting
    • Akdeniz Universitesi Hastanesi
  • Aydin, Turkey, 09100
    • Active, not recruiting
    • Aydın Adnan Menderes Universitesi Hastanesi
  • Gaziantep, Turkey, 27310
    • Active, not recruiting
    • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
  • Kayseri, Turkey, 38030
    • Active, not recruiting
    • Erciyes Universitesi Tıp Fakultesi Hastaneleri
  • Kocaeli, Turkey, 41400
    • Active, not recruiting
    • Özel Anadolu Sağlık Merkezi
  • Malatya, Turkey, 44280
    • Active, not recruiting
    • İnönü Üniversitesi Turgut Özal Tıp Merkezi
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34093
      • Active, not recruiting
      • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
    • Istanbul, İ̇stanbul, Turkey, 34303
      • Active, not recruiting
      • Acibadem Universitesi Atakent Hastanesi
    • İstanbul, İ̇stanbul, Turkey, 34214
      • Active, not recruiting
      • Medipol Mega Universite Hastanesi
    • İstanbul / Şişli, İ̇stanbul, Turkey, 34381
      • Active, not recruiting
      • Sisli Florence Nightingale Hastanesi
  • İ̇zmir
    • İzmir, İ̇zmir, Turkey, 35100
      • Active, not recruiting
      • Ege Universitesi Hastanesi
    • İzmir, İ̇zmir, Turkey, 35340
      • Active, not recruiting
      • Dokuz Eylul Universitesi Hastanesi
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Active, not recruiting
    • Bristol Haematology and Oncology centre
  • Canterbury, United Kingdom, CT1 3NG
    • Active, not recruiting
    • Kent and Canterbury Hospital
  • Manchester, United Kingdom, M20 4BX
    • Active, not recruiting
    • The Christie NHS Foundation Trust
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Active, not recruiting
      • Royal Bournemouth Hospital
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LE
      • Active, not recruiting
      • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Active, not recruiting
      • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Active, not recruiting
      • Churchill Hospital
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
      • Active, not recruiting
      • University Hospital of Wales
• United States
  • California
    • Clovis, California, United States, 93611
      • Active, not recruiting
      • Community Cancer Institute
    • Clovis, California, United States, 93611
      • Active, not recruiting
      • Clovis Community Medical Center
    • Fresno, California, United States, 93701
      • Active, not recruiting
      • University of California San Francisco
    • Fresno, California, United States, 93721
      • Active, not recruiting
      • Community Regional Medical Center
  • Colorado
    • Fort Collins, Colorado, United States, 80524
      • Active, not recruiting
      • UCHealth Poudre Valley Hospital
    • Fort Collins, Colorado, United States, 80528
      • Active, not recruiting
      • UCHealth Harmony
    • Greeley, Colorado, United States, 80634
      • Active, not recruiting
      • UCHealth Greeley Hospital
    • Loveland, Colorado, United States, 80538
      • Active, not recruiting
      • UCHealth - Medical Center of the Rockies
  • Florida
    • Aventura, Florida, United States, 33180
      • Active, not recruiting
      • Sylvester Comprehensive Cancer Center - Aventura
    • Coral Gables, Florida, United States, 33146
      • Active, not recruiting
      • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
    • Coral Springs, Florida, United States, 33065
      • Active, not recruiting
      • Sylvester Comprehensive Cancer Center - Coral Springs
    • Deerfield Beach, Florida, United States, 33442
      • Active, not recruiting
      • University of Miami Hospital and Clinics - Deerfield Beach
    • Hollywood, Florida, United States, 33021
      • Active, not recruiting
      • Sylvester Comprehensive Cancer Center - Hollywood
    • Miami, Florida, United States, 33136
      • Active, not recruiting
      • Sylvester Comprehensive Cancer Center
    • Miami, Florida, United States, 33136
      • Active, not recruiting
      • University of Miami Hospital And Clinics
    • Miami, Florida, United States, 33176
      • Active, not recruiting
      • Sylvester Comprehensive Cancer Center - Kendall
    • Plantation, Florida, United States, 33324
      • Active, not recruiting
      • Sylvester Comprehensive Cancer Center - Plantation
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Active, not recruiting
      • Tulane Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Active, not recruiting
      • Tulane Cancer Center
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Active, not recruiting
      • MSK Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Active, not recruiting
      • MSK Monmouth
    • Montvale, New Jersey, United States, 07645
      • Active, not recruiting
      • MSK Bergen
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Active, not recruiting
      • CHRISTUS St. Vincent Regional Medical Center
    • Santa Fe, New Mexico, United States, 87505
      • Active, not recruiting
      • Christus St. Vincent Regional Cancer Center
    • Santa Fe, New Mexico, United States, 87505
      • Active, not recruiting
      • Santa Fe Imaging
    • Santa Fe, New Mexico, United States, 87505
      • Active, not recruiting
      • X-Ray Associates of Santa Fe - XRANM
  • New York
    • Harrison, New York, United States, 10604
      • Active, not recruiting
      • MSK Westchester
    • New York, New York, United States, 10021
      • Active, not recruiting
      • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
    • New York, New York, United States, 10065
      • Active, not recruiting
      • Memorial Sloan Kettering Cancer Center - Main Campus
    • Uniondale, New York, United States, 11553
      • Active, not recruiting
      • MSK Nassau
  • Texas
    • Dallas, Texas, United States, 75246
      • Active, not recruiting
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 and a proteasome inhibitor.
• 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.
• Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab	Drug: Elranatamab; subcutaneous; Other Names: PF-06863135; Drug: Daratumumab; Daratumumab / hyaluronidase, subcutaneous; Other Names: Darzalex Faspro; Darzalex solution for injection
Experimental: Part 2 Randomized Arm A: Elranatamab	Drug: Elranatamab; subcutaneous; Other Names: PF-06863135
Experimental: Part 2 Randomized Arm B: Elranatamab + Daratumumab	Drug: Elranatamab; subcutaneous; Other Names: PF-06863135; Drug: Daratumumab; Daratumumab / hyaluronidase, subcutaneous; Other Names: Darzalex Faspro; Darzalex solution for injection
Active Comparator: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone	Drug: Daratumumab; Daratumumab / hyaluronidase, subcutaneous; Other Names: Darzalex Faspro; Darzalex solution for injection; Drug: Pomalidomide; oral; Other Names: Pomalyst, Imnovid; Drug: Dexamethasone; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of treatment-emergent adverse events	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.
Frequency of abnormal laboratory results	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.
Rate of Grade ≥2 cytokine release syndrome	First 28 days after first elranatamab dose
Elranatamab pharmacokinetics by pre- and post-dose concentrations	From date of first dose through up to 14 days after date of last dose of elranatamab
Elranatamab immunogenicity by anti-drug antibodies against elranatamab	From date of first dose through up to 14 days after date of last dose of elranatamab
Daratumumab pharmacokinetics by pre-dose concentrations	From date of first dose through up to 14 days after date of last dose of daratumumab
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30	From date of informed consent through up to 35 days after date of last dose of study intervention
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20	From date of informed consent through up to 35 days after date of last dose of study intervention
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
Complete 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 complete response per International Myeloma Working Group criteria	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
Minimal residual disease negativity 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
Sustained minimal residual disease negativity 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
Progression free survival on next-line treatment per International Myeloma Working Group criteria	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Estimated): December 27, 2024
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Multiple myeloma; Pomalidomide; Daratumumab; PF-06863135; BCMA; Elranatamab; Bispecific antibody; B-Cell Maturation Antigen; BCMA-CD3 bispecific antibody; Relapsed multiple myeloma; Refractory multiple myeloma; MagnetisMM-5
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Pomalidomide; Daratumumab
• Other Study ID Numbers: C1071005; 2021-000044-22 (EudraCT Number); MAGNETISMM-5 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No