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)

August 20, 2026 updated by: Pfizer

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

893

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1114AAN
        • Recruiting
        • FUNDALEU - Fundacion para combatir la Leucemia
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1426
        • Terminated
        • Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1114AAP
        • Recruiting
        • FUNDALEU -Fundación para combatir la leucemia
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1114AAP
        • Recruiting
        • Fundaleu
      • La Plata, Buenos Aires, Argentina, B1900XI
        • Active, not recruiting
        • Hospital Italiano de La Plata
      • Presidente Derqui, Buenos Aires, Argentina, B1629AHJ
        • Active, not recruiting
        • Hospital Universitario Austral
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000ORE
        • Active, not recruiting
        • Sanatorio de la Mujer
  • Australia
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • Recruiting
        • Pindara Private Hospital
      • Clayfield, Queensland, Australia, 4011
        • 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
        • Recruiting
        • Princess Alexandra Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Epworth Freemasons
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital (Melbourne)
      • Geelong, Victoria, Australia, 3220
        • Recruiting
        • Barwon Health
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Epworth Healthcare
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Slade Pharmacy
    • Western Australia
      • 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
        • Recruiting
        • Uniklinikum Salzburg
      • Vienna, Austria, 1090
        • Active, not recruiting
        • Medizinische Universität Wien
    • Lower Austria
      • Krems, Lower Austria, Austria, 3500
        • Active, not recruiting
        • Universitatsklinikum Krems
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1160
        • Active, not recruiting
        • Klinik Ottakring
  • Belgium
    • Hainaut
      • Gilly, Hainaut, Belgium, 6060
        • 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 Educacao, Pesquisa e Gestao em Saude
      • 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)
    • Estado de Bahia
      • Salvador, Estado de 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 Gaúcho 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
    • São Paulo
      • SP, São Paulo, Brazil, 04537-080
        • Active, not recruiting
        • Clinica Medica Sao Germano LTDA
      • São Paulo, São Paulo, Brazil, 01321-001
        • Active, not recruiting
        • BP - A Beneficência Portuguesa de São Paulo
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Active, not recruiting
        • Cross Cancer Institute
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site
    • 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
        • Recruiting
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H1T2M4
        • Active, not recruiting
        • CIUSSS de l'Est-de-l'Ile-de-Montreal
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N4H4
        • Recruiting
        • Saskatoon Cancer Center
  • China
      • Beijing, China, 100070
        • Active, not recruiting
        • Beijing Boren Hospital
      • Beijing, China, 100730
        • Active, not recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third 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
        • Active, not recruiting
        • The Second Hospital of Hebei Medical University
    • 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
        • Active, not recruiting
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Active, not recruiting
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First hospital of Jilin University
      • Changchun, Jilin, China, 130000
        • Active, not recruiting
        • Jilin Province Cancer Hospital
    • Shandong
      • Jinan, Shandong, China, 250100
        • Recruiting
        • Jinan Central Hospital
      • Jinan, Shandong, China, 250021
        • Active, not recruiting
        • Shandong Provincial Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 301636
        • 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 Králové, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 779 00
        • Active, not recruiting
        • Fakultni nemocnice Olomouc
      • Ostrava-Poruba, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava
      • Prague, Czechia, 12808
        • Recruiting
        • Vseobecna Fakultni nemocnice v Praze
    • Brno-m?sto
      • Brno, Brno-m?sto, Czechia, 625 00
        • Recruiting
        • Fakultní nemocnice Brno Bohunice
    • Plzeň Region
      • Plzen - Lochotin, Plzeň Region, Czechia, 304 60
        • Recruiting
        • Fakultni nemocnice Plzen
    • Praha 2
      • Prague, Praha 2, Czechia, 120 00
        • Recruiting
        • Fakultni poliklinika
  • Finland
      • Helsinki, Finland, 00029
        • Active, not recruiting
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
      • Oulu, Finland, 90220
        • Active, not recruiting
        • Oulun yliopistollinen sairaala
      • Tampere, Finland, 33520
        • Active, not recruiting
        • Tampereen yliopistollinen sairaala
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Active, not recruiting
        • Kuopion Yliopistollinen Sairaala
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Active, not recruiting
        • Tampereen yliopistollinen sairaala
    • Southwest Finland
      • Turku, Southwest Finland, 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
      • Paris, France, 75571
        • Recruiting
        • Hôpital Saint Antoine
      • Paris, France, 75015
        • Active, not recruiting
        • Hôpital Necker
      • Pierre-Bénite, France, 69495
        • Active, not recruiting
        • Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
      • Poitiers, France, 86021
        • 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
    • Limousin
      • Limoges, Limousin, France, 87042
        • Recruiting
        • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
    • NORD
      • Lille, NORD, France, 59000
        • Active, not recruiting
        • Hopital Claude Huriez - CHU de Lille
  • Germany
      • Berlin, Germany, 12203
        • Active, not recruiting
        • Charité Universitätsmedizin Berlin
      • Braunschweig, Germany, 38114
        • Recruiting
        • Staedtisches Klinikum Braunschweig gGmbH
      • Chemnitz, Germany, 09116
        • Recruiting
        • Klinikum Chemnitz gGmbH
      • München, Germany, 81675
        • Recruiting
        • Universitätsklinikum rechts der Isar, Technische Universität München (TUM)
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Active, not recruiting
        • Universitaetsklinikum Ulm
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Active, not recruiting
        • Universitätsklinikum Würzburg
  • Greece
      • 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, 115 25
        • Active, not recruiting
        • Radiology vendor
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Greece, 546 39
        • Active, not recruiting
        • Theageneio Cancer Hospital of Thessaloniki
  • Italy
      • Bologna, Italy, 40138
        • Active, not recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)
      • Roma, Italy, 00161
        • 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"
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Monza, Lombardy, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
    • Milan
      • Milan, Milan, Italy, 20153
        • Active, not recruiting
        • ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)
    • Sicily
      • Catania, Sicily, Italy, 95123
        • Recruiting
        • Policlinico "G. Rodolico"
  • Japan
      • Akita, Japan, 010-8543
        • Recruiting
        • Akita University Hospital
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
      • Kagoshima, Japan, 890-8520
        • Active, not recruiting
        • Kagoshima University Hospital
      • Kumamoto, Japan, 860-0008
        • Recruiting
        • National Hospital Organization Kumamoto Medical Center
      • Nagasaki, Japan, 852-8501
        • 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-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Active, not recruiting
        • Nagoya City University 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, Iwate, Japan, 028-3695
        • Active, not recruiting
        • Iwate Medical University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Active, not recruiting
        • Tohoku University Hospital
    • Shizuoka
      • 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
  • Mexico
      • Oaxaca City, 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, 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
    • South Holland
      • Rotterdam, South 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, 1060
        • Active, not recruiting
        • Labtests Auckland Ltd.
      • Hamilton, New Zealand, 3204
        • Active, not recruiting
        • Waikato District Health Board, Waikato Hospital
      • Milford, New Zealand, 0620
        • Active, not recruiting
        • TRG Imaging
      • Newtown, 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, 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
        • Recruiting
        • Haukeland Universitetssjukehus
    • Rogaland
      • Stavanger, Rogaland, Norway, 4021
        • Recruiting
        • Stavanger Universitetssykehus
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Active, not recruiting
        • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii
      • 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
      • Warsaw, Poland, 02-097
        • Active, not recruiting
        • Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
      • Wroclaw, Poland, 50-367
        • Active, not recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • South Korea
      • Incheon, South Korea, 21565
        • Active, not recruiting
        • Gachon University Gil Medical Center
      • Seoul, South Korea, 05505
        • Active, not recruiting
        • Asan Medical Center
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Active, not recruiting
        • Seoul National University Bundang Hospital
    • Jeonranamdo
      • Hwasun-gun, Jeonranamdo, South Korea, 58128
        • Active, not recruiting
        • Chonnam National University Hwasun Hospital
    • Pusan-kwangyǒkshi
      • Busan, Pusan-kwangyǒkshi, South Korea, 49241
        • Active, not recruiting
        • Pusan National University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
        • Active, not recruiting
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06591
        • Active, not recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
        • Active, not recruiting
        • Seoul National University Hospital
    • Taegu-kwangyǒkshi
      • Daegu, Taegu-kwangyǒkshi, South Korea, 41944
        • Active, not recruiting
        • Kyungpook National University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Active, not recruiting
        • Hospital Clinic Barcelona
      • Girona, Spain, 17007
        • Active, not recruiting
        • Hospital Universitari de Girona Doctor Josep Trueta
      • Madrid, Spain, 28006
        • 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
      • Seville, Spain, 41013
        • Active, not recruiting
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Active, not recruiting
        • Hospital Universitario Y Politecnico La Fe
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago
    • Barcelona
      • 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
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
    • Navarre
      • Pamplona, Navarre, 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
        • Recruiting
        • Södra Älvsborg Sjukhus
      • Falun, Sweden, 791 82
        • Active, not recruiting
        • Falu Lasarett
      • Gothenburg, Sweden, 41345
        • Active, not recruiting
        • Sahlgrenska Universitetssjukhuset
      • Luleå, Sweden, 971 80
        • Active, not recruiting
        • Sunderby Sjukhus
    • Skåne LÄN [se-12]
      • 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
        • Recruiting
        • Universitetssjukhuset i Linköping
      • Linköping, Östergötlands LÄN [se-05], Sweden, 581 85
        • Recruiting
        • Läkemedelsberedningen
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • 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
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • National Taiwan University Hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01240
        • Terminated
        • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
      • Ankara, Turkey (Türkiye), 06100
        • Active, not recruiting
        • Ankara University Health Practice and Research Hospitals
      • Ankara, Turkey (Türkiye), 06200
        • Active, not recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
      • Antalya, Turkey (Türkiye), 07070
        • Active, not recruiting
        • Akdeniz Universitesi Hastanesi
      • Gaziantep, Turkey (Türkiye), 27310
        • Active, not recruiting
        • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
      • Istanbul, Turkey (Türkiye), 34381
        • Active, not recruiting
        • Sisli Florence Nightingale Hastanesi
      • Kayseri, Turkey (Türkiye), 38030
        • Active, not recruiting
        • Erciyes Universitesi Tıp Fakultesi Hastaneleri
      • Kocaeli, Turkey (Türkiye), 41400
        • Active, not recruiting
        • Özel Anadolu Sağlık Merkezi
      • Malatya, Turkey (Türkiye), 44280
        • Terminated
        • Inonu Universitesi Turgut Ozal Tıp Merkezi
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey (Türkiye), 34093
        • Active, not recruiting
        • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
      • Istanbul, İ̇stanbul, Turkey (Türkiye), 34214
        • Active, not recruiting
        • Medipol Mega Üniversite Hastanesi
      • Istanbul, İ̇stanbul, Turkey (Türkiye), 34303
        • Active, not recruiting
        • Acibadem Universitesi Atakent Hastanesi
    • İ̇zmir
      • Izmir, İ̇zmir, Turkey (Türkiye), 35100
        • Active, not recruiting
        • Ege Universitesi Hastanesi
      • Izmir, İ̇zmir, Turkey (Türkiye), 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
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Active, not recruiting
        • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
    • 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
        • Recruiting
        • Sylvester Comprehensive Cancer Center - Aventura
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • Sylvester Comprehensive Cancer Center - Coral Springs
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • University of Miami Hospital and Clinics - Deerfield Beach
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Sylvester Comprehensive Cancer Center - Hollywood
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics
      • Miami, Florida, United States, 33176
        • Recruiting
        • Sylvester Comprehensive Cancer Center - Kendall
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Sylvester Comprehensive Cancer Center - Plantation
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Active, not recruiting
        • East Jefferson General Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • MSK Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • MSK Monmouth
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • MSK Bergen
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • MSK Commack
      • Harrison, New York, United States, 10604
        • Recruiting
        • MSK Westchester
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - Main Campus
      • New York, New York, United States, 10021
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
      • Uniondale, New York, United States, 11553
        • Recruiting
        • MSK Nassau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

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
Experimental: Part 3 Arm D: Elranatamab
Drug: Elranatamab
subcutaneous
Other Names:
  • PF-06863135
Experimental: Part 3 Arm E: Elranatamab + Daratumumab
Drug: Elranatamab
subcutaneous
Other Names:
  • PF-06863135
Drug: Daratumumab
Daratumumab / hyaluronidase, subcutaneous
Other Names:
  • Darzalex Faspro; Darzalex solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1 Safety Lead-In: Incidence of dose limiting toxicities
Time Frame: First 42 days after first elranatamab dose
First 42 days after first elranatamab dose
Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
Time Frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
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
Time Frame: First 84 days after first elranatamab dose
First 84 days after first elranatamab dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of treatment-emergent adverse events
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: First 28 days after first elranatamab dose
First 28 days after first elranatamab dose
Elranatamab pharmacokinetics by pre- and post-dose concentrations
Time Frame: From date of first dose through up to 14 days after date of last dose of elranatamab
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
Time Frame: From date of first dose through up to 14 days after date of last dose of elranatamab
From date of first dose through up to 14 days after date of last dose of elranatamab
Daratumumab pharmacokinetics by pre-dose concentrations
Time Frame: From date of first dose through up to 14 days after date of last dose of daratumumab
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
Time Frame: From date of informed consent through up to 35 days after date of last dose of study intervention
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
Time Frame: From date of informed consent through up to 35 days after date of last dose of study intervention
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
Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
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
Time Frame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: From date of randomization to date of confirmed objective response, assessed up to 51 months
From date of randomization to date of confirmed objective response, assessed up to 51 months
Complete response rate per International Myeloma Working Group criteria
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

February 26, 2026

Study Completion (Estimated)

May 31, 2027

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)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1071005
  • MAGNETISMM-5 (Other Identifier: Alias Study Number)
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-509208-14-00 (Registry Identifier: CTIS (EU))

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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