AzTrials
AzTrials

Multiple MyelomaPhase 3MAGNETISMM-5NCT05020236

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

A Phase 3 study testing Elranatamab, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Pfizer at 237 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Elranatamab, Daratumumab and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
893 participants
Where
237 sitesin 26 countries
Study dates
4 Oct 2021to 31 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

237 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

237 sites in 26 countries

United States26 sites, 17 recruiting

  • Sylvester Comprehensive Cancer Center - Aventura

    Aventura, Florida, 33180

    Recruiting

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

    Recruiting

  • Clovis Community Medical Center

    Clovis, California, 93611

    Active, not recruiting

  • Community Cancer Institute

    Clovis, California, 93611

    Active, not recruiting

  • MSK Commack

    Commack, New York, 11725

    Recruiting

  • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

    Recruiting

  • Sylvester Comprehensive Cancer Center - Coral Springs

    Coral Springs, Florida, 33065

    Recruiting

  • University of Miami Hospital and Clinics - Deerfield Beach

    Deerfield Beach, Florida, 33442

    Recruiting

  • UCHealth Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Active, not recruiting

  • UCHealth Harmony

    Fort Collins, Colorado, 80528

    Active, not recruiting

  • University of California San Francisco

    Fresno, California, 93701

    Active, not recruiting

  • Community Regional Medical Center

    Fresno, California, 93721

    Active, not recruiting

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80634

    Active, not recruiting

  • MSK Westchester

    Harrison, New York, 10604

    Recruiting

  • Sylvester Comprehensive Cancer Center - Hollywood

    Hollywood, Florida, 33021

    Recruiting

  • UCHealth - Medical Center of the Rockies

    Loveland, Colorado, 80538

    Active, not recruiting

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

    Active, not recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Recruiting

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

    Recruiting

  • Sylvester Comprehensive Cancer Center - Kendall

    Miami, Florida, 33176

    Recruiting

  • MSK Monmouth

    Middletown, New Jersey, 07748

    Recruiting

  • MSK Bergen

    Montvale, New Jersey, 07645

    Recruiting

  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

    New York, New York, 10021

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065

    Recruiting

  • Sylvester Comprehensive Cancer Center - Plantation

    Plantation, Florida, 33324

    Recruiting

  • MSK Nassau

    Uniondale, New York, 11553

    Recruiting

Other trials in United States

China22 sites, 15 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Recruiting

  • Beijing Boren Hospital

    Beijing, 100070

    Active, not recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, 100730

    Active, not recruiting

  • Jilin Province Cancer Hospital

    Changchun, Jilin, 130000

    Active, not recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

    Recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

    Active, not recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250100

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Active, not recruiting

  • Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518035

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Active, not recruiting

  • Institute of hematology&blood disease hospital

    Tianjin, Tianjin Municipality, 301636

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

    Active, not recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Recruiting

Other trials in China

Japan16 sites, 4 recruiting

  • Akita University Hospital

    Akita, 010-8543

    Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

    Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520

    Active, not recruiting

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

    Recruiting

  • Nagasaki University Hospital

    Nagasaki, 852-8501

    Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

    Active, not recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

    Active, not recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

    Active, not recruiting

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Active, not recruiting

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa, Gunma, 377-0280

    Active, not recruiting

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935

    Active, not recruiting

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

    Active, not recruiting

  • Tokushima University Hospital

    Tokushima, 770-8503

    Active, not recruiting

  • Iwate Medical University Hospital

    Yahaba-cho, Iwate, 028-3695

    Active, not recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Active, not recruiting

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193

    Active, not recruiting

Other trials in Japan

Brazil15 sites

  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

    Porto Alegre, Rio Grande do Sul, 90110-270

    Active, not recruiting

  • Centro de Pesquisa Clínica - Área Administrativa

    Porto Alegre, Rio Grande do Sul, 90850-170

    Active, not recruiting

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90880-480

    Active, not recruiting

  • Hospital Américas Medical City

    Rio de Janeiro, 22775001

    Active, not recruiting

  • Instituto de Educação, Pesquisa e Gestão em Saúde

    Rio de Janeiro, 22793-080

    Active, not recruiting

  • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

    Salvador, Estado de Bahia, 41253-190

    Active, not recruiting

  • BP - A Beneficencia Portuguesa de São Paulo

    São Paulo, São Paulo, 01321-001

    Active, not recruiting

  • ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis

    São Paulo, 01232-010

    Active, not recruiting

  • IDOR Ensino e Pesquisa

    São Paulo, 01401-002.

    Active, not recruiting

  • HU UNIFESP / SPDM - Hospital São Paulo

    São Paulo, 04024-002

    Active, not recruiting

  • Universidade Federal de Sao Paulo

    São Paulo, 04024-002

    Active, not recruiting

  • Clínica Médica São Germano S/S Ltda

    São Paulo, 04537-080

    Active, not recruiting

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    São Paulo, 04543-000

    Active, not recruiting

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    São Paulo, 04544-000

    Active, not recruiting

  • Clínica Médica São Germano LTDA

    SP, São Paulo, 04537-080

    Active, not recruiting

Other trials in Brazil

Spain14 sites, 3 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Active, not recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Active, not recruiting

  • Hospital Universitari De Girona Doctor Josep Trueta

    Girona, 17007

    Active, not recruiting

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet Del Llobregat, Barcelona [barcelona], 08908

    Active, not recruiting

  • Hospital Universitario La Princesa

    Madrid, 28006

    Recruiting

  • Hospital Universitario Madrid Sanchinarro

    Madrid, 28050

    Active, not recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Active, not recruiting

  • Hospital Universitario de Salamanca

    Salamanca, 37007

    Active, not recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruna, 15706

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Active, not recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona, 08221

    Active, not recruiting

  • Hospital Universitario de Toledo

    Toledo, Other, 45007

    Active, not recruiting

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

    Active, not recruiting

Other trials in Spain

Turkey (Türkiye)14 sites

  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01240

    Terminated

  • Ankara University Health Practice and Research Hospitals

    Ankara, 06100

    Active, not recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

    Ankara, 06200

    Active, not recruiting

  • Akdeniz Universitesi Hastanesi

    Antalya, 07070

    Active, not recruiting

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310

    Active, not recruiting

  • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi

    Istanbul, İ̇stanbul, 34093

    Active, not recruiting

  • Medipol Mega Universite Hastanesi

    Istanbul, İ̇stanbul, 34214

    Active, not recruiting

  • Acibadem Universitesi Atakent Hastanesi

    Istanbul, İ̇stanbul, 34303

    Active, not recruiting

  • Sisli Florence Nightingale Hastanesi

    Istanbul, 34381

    Active, not recruiting

  • Ege Universitesi Hastanesi

    Izmir, İ̇zmir, 35100

    Active, not recruiting

  • Dokuz Eylul Universitesi Hastanesi

    Izmir, İ̇zmir, 35340

    Active, not recruiting

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri

    Kayseri, 38030

    Active, not recruiting

  • Özel Anadolu Sağlık Merkezi

    Kocaeli, 41400

    Active, not recruiting

  • Inonu Universitesi Turgut Ozal Tıp Merkezi

    Malatya, 44280

    Terminated

Other trials in Turkey (Türkiye)

Australia12 sites, 9 recruiting

  • Pindara Private Hospital

    Benowa, Queensland, 4217

    Recruiting

  • QScan Radiology Clinics

    Clayfield, Queensland, 4011

    Recruiting

  • Epworth Freemasons

    East Melbourne, Victoria, 3002

    Recruiting

  • St Vincent's Hospital (Melbourne)

    Fitzroy, Victoria, 3065

    Recruiting

  • Barwon Health

    Geelong, Victoria, 3220

    Recruiting

  • Gallipoli Medical Research Foundation

    Greenslopes, Queensland, 4120

    Active, not recruiting

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

    Active, not recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

  • Linear Clinical Research

    Perth, Western Australia, 6009

    Active, not recruiting

  • Epworth Healthcare

    Richmond, Victoria, 3121

    Recruiting

  • Slade Pharmacy

    Richmond, Victoria, 3121

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

New Zealand10 sites

  • North Shore Hospital

    Auckland, 0622

    Active, not recruiting

  • Labtests Auckland Ltd.

    Auckland, 1060

    Active, not recruiting

  • Aotearoa Clinical Trials

    Auckland, 2025

    Active, not recruiting

  • Waikato District Health Board, Waikato Hospital

    Hamilton, 3204

    Active, not recruiting

  • TRG Imaging

    Milford, 0620

    Active, not recruiting

  • Pacific Radiology

    Newtown, 6021

    Active, not recruiting

  • Broadway Radiology

    Palmerston North, 4410

    Active, not recruiting

  • Palmerston North Hospital

    Roslyn, 4414

    Active, not recruiting

  • Pharmacy on Shakespeare

    Takapuna, 0620

    Active, not recruiting

  • Capital, Coast and Hutt Valley District - Wellington Regional Hospital

    Wellington, 6021

    Active, not recruiting

Other trials in New Zealand

Italy9 sites, 5 recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138

    Active, not recruiting

  • Policlinico "G. Rodolico"

    Catania, Sicily, 95123

    Recruiting

  • IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)

    Genova, 16132

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna, 47014

    Active, not recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

    Recruiting

  • ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)

    Milan, Milan, 20153

    Active, not recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy, 20900

    Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Active, not recruiting

Other trials in Italy

South Korea9 sites

  • Pusan National University Hospital

    Busan, Pusan-kwangyǒkshi, 49241

    Active, not recruiting

  • Kyungpook National University Hospital

    Daegu, Taegu-kwangyǒkshi, 41944

    Active, not recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeonranamdo, 58128

    Active, not recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Active, not recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

    Active, not recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

    Active, not recruiting

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 06591

    Active, not recruiting

  • Asan Medical Center

    Seoul, 05505

    Active, not recruiting

Other trials in South Korea

Canada8 sites, 4 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Active, not recruiting

  • QEII Health Sciences Centre - Victoria General Site

    Halifax, Nova Scotia, B3H 2Y9

    Recruiting

  • Hamilton Health Sciences-Juravinski Cancer Centre

    Hamilton, Ontario, L8V5C2

    Active, not recruiting

  • CIUSSS de l'Est-de-l'Île-de-Montréal

    Montreal, Quebec, H1T2M4

    Active, not recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Saskatoon Cancer Center

    Saskatoon, Saskatchewan, S7N4H4

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Active, not recruiting

Other trials in Canada

France8 sites, 3 recruiting

  • Hopital Claude Huriez - CHU de Lille

    Lille, NORD, 59000

    Active, not recruiting

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

    Limoges, Limousin, 87042

    Recruiting

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, 44093

    Active, not recruiting

  • Hopital Necker

    Paris, 75015

    Active, not recruiting

  • Hôpital Saint Antoine

    Paris, 75571

    Recruiting

  • Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

    Pierre-Bénite, 69495

    Active, not recruiting

  • CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie

    Poitiers, 86021

    Recruiting

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

    Toulouse, 31059

    Active, not recruiting

Other trials in France

Sweden8 sites, 3 recruiting

  • Södra Älvsborg Sjukhus

    Borås, 501 82

    Recruiting

  • Falu Lasarett

    Falun, 791 82

    Active, not recruiting

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41345

    Active, not recruiting

  • Läkemedelsberedningen

    Linköping, Östergötlands LÄN [se-05], 581 85

    Recruiting

  • Universitetssjukhuset i Linköping

    Linköping, Östergötlands LÄN [se-05], 581 85

    Recruiting

  • Sunderby Sjukhus

    Luleå, 971 80

    Active, not recruiting

  • Skånes Universitetssjukhus Lund

    Lund, Skåne LÄN [se-12], 22185

    Active, not recruiting

  • Universitetssjukhuset Örebro

    Örebro, Örebro LÄN [se-18], 701 85

    Active, not recruiting

Other trials in Sweden

Argentina7 sites, 3 recruiting

  • Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426

    Terminated

  • FUNDALEU - Fundacion para combatir la Leucemia

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1114AAN

    Recruiting

  • FUNDALEU -Fundación para combatir la leucemia

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1114AAP

    Recruiting

  • FUNDALEU

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1114AAP

    Recruiting

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, B1900XI

    Active, not recruiting

  • Hospital Universitario Austral

    Presidente Derqui, Buenos Aires, B1629AHJ

    Active, not recruiting

  • Sanatorio de La Mujer

    Rosario, Santa Fe Province, S2000ORE

    Active, not recruiting

Other trials in Argentina

Czechia7 sites, 6 recruiting

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-m?sto, 625 00

    Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Active, not recruiting

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

    Recruiting

  • Fakultni Nemocnice Plzen

    Plzen - Lochotin, Plzeň Region, 304 60

    Recruiting

  • Fakultni poliklinika

    Prague, Praha 2, 120 00

    Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

    Recruiting

Other trials in Czechia

Poland7 sites

  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii

    Bydgoszcz, 85-168

    Active, not recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Active, not recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569

    Active, not recruiting

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185

    Active, not recruiting

  • Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny

    Warsaw, 02-097

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-367

    Active, not recruiting

Other trials in Poland

Finland6 sites

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

    Helsinki, 00029

    Active, not recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Northern Savonia, 70210

    Active, not recruiting

  • Oulun yliopistollinen sairaala

    Oulu, 90220

    Active, not recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520

    Active, not recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, 33520

    Active, not recruiting

  • Turku University Hospital

    Turku, Southwest Finland, 20520

    Active, not recruiting

Other trials in Finland

Germany6 sites, 3 recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 12203

    Active, not recruiting

  • Staedtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

    Recruiting

  • Klinikum Chemnitz gGMbH

    Chemnitz, 09116

    Recruiting

  • Universitätsklinikum rechts der Isar, Technische Universität München (TUM)

    München, 81675

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

    Active, not recruiting

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

    Active, not recruiting

Other trials in Germany

United Kingdom6 sites

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

    Active, not recruiting

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

    Active, not recruiting

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

    Active, not recruiting

  • University Hospital of Wales

    Cardiff, South Glamorgan, CF14 4XW

    Active, not recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Active, not recruiting

  • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 7LE

    Active, not recruiting

Other trials in United Kingdom

Austria5 sites, 1 recruiting

  • Universitätsklinik für Innere Medizin V Innsbruck

    Innsbruck, 6020

    Active, not recruiting

  • Universitätsklinikum Krems

    Krems, Lower Austria, 3500

    Active, not recruiting

  • Uniklinikum Salzburg

    Salzburg, 5020

    Recruiting

  • Klinik Ottakring

    Vienna, State of Vienna, 1160

    Active, not recruiting

  • Medizinische Universität Wien

    Vienna, 1090

    Active, not recruiting

Other trials in Austria

Greece5 sites

  • Evangelismos General Hospital of Athens

    Athens, Attikí, 106 76

    Active, not recruiting

  • Radiology vendor

    Athens, Attikí, 115 25

    Active, not recruiting

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

    Active, not recruiting

  • University General Hospital of Ioannina

    Ioannina

    Active, not recruiting

  • Theageneio Cancer Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía, 546 39

    Active, not recruiting

Other trials in Greece

Taiwan5 sites, 2 recruiting

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung City, 83301

    Recruiting

  • China Medical University Hospital

    Taichung, 40447

    Active, not recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Active, not recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Active, not recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

Mexico4 sites

  • Hematológica Alta Especialidad SC, consultorio 830

    Colonia Valle de Las Palmas, México, 52787

    Active, not recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460

    Active, not recruiting

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

    Active, not recruiting

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851

    Active, not recruiting

Other trials in Mexico

Norway4 sites, 2 recruiting

  • Haukeland Universitetssjukehus

    Bergen, Hordaland, 5021

    Recruiting

  • Oslo Universitetssykehus Ullevål

    Oslo, 0450

    Active, not recruiting

  • Stavanger Universitetssykehus

    Stavanger, Rogaland, 4021

    Recruiting

  • St Olavs Hospital

    Trondheim, 7030

    Active, not recruiting

Other trials in Norway

Belgium2 sites

  • Grand Hôpital de Charleroi

    Gilly, Hainaut, 6060

    Active, not recruiting

  • CHU UCL Namur (site Godinne)

    Yvoir, Namur, 5530

    Active, not recruiting

Other trials in Belgium

Netherlands2 sites

  • Maastricht University Medical Center

    Maastricht, 6229 HX

    Active, not recruiting

  • Erasmus Universitair Medisch Centrum

    Rotterdam, South Holland, 3015 GD

    Active, not recruiting

Other trials in Netherlands

About this study

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

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.

Read more

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.

Being tested
Elranatamab, Daratumumab, Pomalidomide, Dexamethasone
Keywords
Elranatamab, PF-06863135, B-Cell Maturation Antigen, BCMA, Bispecific antibody, BCMA-CD3 bispecific antibody, Daratumumab, Pomalidomide, Multiple myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, MagnetisMM-5
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElranatamabDrug

    Also called PF-06863135

    subcutaneous

  • DaratumumabDrug

    Also called Darzalex Faspro; Darzalex solution for injection

    Daratumumab / hyaluronidase, subcutaneous

  • PomalidomideDrug

    Also called Pomalyst, Imnovid

    oral

  • DexamethasoneDrug

    oral

Study groups in NCT05020236
Study groupRoleWhat they receive
Part 1 Safety Lead-In Dose Escalation: Elranatamab + DaratumumabExperimentalNot described
Receives: Drug: Elranatamab; Drug: Daratumumab
Part 2 Randomized Arm A: ElranatamabExperimentalNot described
Receives: Drug: Elranatamab
Part 2 Randomized Arm B: Elranatamab + DaratumumabExperimentalNot described
Receives: Drug: Elranatamab; Drug: Daratumumab
Part 2 Randomized Arm C: Daratumumab + Pomalidomide + DexamethasoneActive comparatorNot described
Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone
Part 3 Arm D: ElranatamabExperimentalNot described
Receives: Drug: Elranatamab
Part 3 Arm E: Elranatamab + DaratumumabExperimentalNot described
Receives: Drug: Elranatamab; Drug: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 Safety Lead-In: Incidence of dose limiting toxicities

    Measured: First 42 days after first elranatamab dose

  2. Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria

    Measured: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months

  3. Part 3: Frequency of treatment-emergent adverse events

    Measured: First 84 days after first elranatamab dose

Secondary outcomes (18)

  1. Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria

    Measured: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  2. Overall survival

    Measured: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  3. Objective response rate per International Myeloma Working Group criteria

    Measured: 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

  4. Duration of response per International Myeloma Working Group criteria

    Measured: 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

  5. Time to response per International Myeloma Working Group criteria

    Measured: From date of randomization to date of confirmed objective response, assessed up to 51 months

  6. Complete response rate per International Myeloma Working Group criteria

    Measured: 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

  7. Duration of complete response per International Myeloma Working Group criteria

    Measured: 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

  8. Minimal residual disease negativity rate per International Myeloma Working Group criteria

    Measured: 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

  9. Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria

    Measured: 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

  10. Progression free survival on next-line treatment per International Myeloma Working Group criteria

    Measured: 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

  11. Frequency of treatment-emergent adverse events

    Measured: 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.

  12. Frequency of abnormal laboratory results

    Measured: 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.

  13. Rate of Grade ≥2 cytokine release syndrome

    Measured: First 28 days after first elranatamab dose

  14. Elranatamab pharmacokinetics by pre- and post-dose concentrations

    Measured: From date of first dose through up to 14 days after date of last dose of elranatamab

  15. Elranatamab immunogenicity by anti-drug antibodies against elranatamab

    Measured: From date of first dose through up to 14 days after date of last dose of elranatamab

  16. Daratumumab pharmacokinetics by pre-dose concentrations

    Measured: From date of first dose through up to 14 days after date of last dose of daratumumab

  17. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30

    Measured: From date of informed consent through up to 35 days after date of last dose of study intervention

  18. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20

    Measured: From date of informed consent through up to 35 days after date of last dose of study intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start4 Oct 2021
  3. Primary completion26 Feb 2026
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
893 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05020236
Sponsor's protocol ID
C1071005
Other IDs
MAGNETISMM-5, 2023-509208-14-00, 2023
Acronym
MAGNETISMM-5
Status last verified
Aug 2026
First submitted
11 Aug 2021
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elranatamab, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Pfizer at 237 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 237 sites in United States, China, Japan, Brazil, Spain and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 Safety Lead-In: Incidence of dose limiting toxicities (time frame: First 42 days after first elranatamab dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05020236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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