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NCT05020236PHASE3Recruiting

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

Pfizer

Start Date

10/4/2021

Completion Date

5/31/2027

Summary

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Elranatamab

DRUG

Daratumumab

DRUG

Pomalidomide

DRUG

Dexamethasone

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Conditions

Multiple Myeloma

Locations

Clovis Community Medical Center

Clovis, California 93611

United States

Community Cancer Institute

Clovis, California 93611

United States

University of California San Francisco

Fresno, California 93701

United States

Community Regional Medical Center

Fresno, California 93721

United States

UCHealth Poudre Valley Hospital

Fort Collins, Colorado 80524

United States

UCHealth Harmony

Fort Collins, Colorado 80528

United States

UCHealth Greeley Hospital

Greeley, Colorado 80634

United States

UCHealth - Medical Center of the Rockies

Loveland, Colorado 80538

United States

Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida 33180

United States

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

Coral Gables, Florida 33146

United States

Sylvester Comprehensive Cancer Center - Coral Springs

Coral Springs, Florida 33065

United States

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida 33442

United States

Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida 33021

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

University of Miami Hospital and Clinics

Miami, Florida 33136

United States

Sylvester Comprehensive Cancer Center - Kendall

Miami, Florida 33176

United States

Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida 33324

United States

East Jefferson General Hospital

Metairie, Louisiana 70006

United States

MSK Basking Ridge

Basking Ridge, New Jersey 07920

United States

MSK Monmouth

Middletown, New Jersey 07748

United States

MSK Bergen

Montvale, New Jersey 07645

United States

MSK Commack

Commack, New York 11725

United States

MSK Westchester

Harrison, New York 10604

United States

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

New York, New York 10021

United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York 10065

United States

MSK Nassau

Uniondale, New York 11553

United States

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

Ciudad Autonoma de Buenos Aires, Buenos Aires 1426

Argentina

FUNDALEU - Fundacion para combatir la Leucemia

Ciudad Autonoma de Buenos Aires, Buenos Aires C1114AAN

Argentina

FUNDALEU -Fundación para combatir la leucemia

Ciudad Autónoma de Buenos Aires, Buenos Aires C1114AAP

Argentina

FUNDALEU

Ciudad Autónoma de Buenos Aires, Buenos Aires C1114AAP

Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires B1900XI

Argentina

Hospital Universitario Austral

Presidente Derqui, Buenos Aires B1629AHJ

Argentina

Sanatorio de La Mujer

Rosario, Santa Fe Province S2000ORE

Argentina

Pindara Private Hospital

Benowa, Queensland 4217

Australia

QScan Radiology Clinics

Clayfield, Queensland 4011

Australia

Gallipoli Medical Research Foundation

Greenslopes, Queensland 4120

Australia

Greenslopes Private Hospital

Greenslopes, Queensland 4120

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Epworth Freemasons

East Melbourne, Victoria 3002

Australia

St Vincent's Hospital (Melbourne)

Fitzroy, Victoria 3065

Australia

Barwon Health

Geelong, Victoria 3220

Australia

The Alfred Hospital

Melbourne, Victoria 3004

Australia

Epworth Healthcare

Richmond, Victoria 3121

Australia

Slade Pharmacy

Richmond, Victoria 3121

Australia

Linear Clinical Research

Perth, Western Australia 6009

Australia

Universitätsklinikum Krems

Krems, Lower Austria 3500

Austria

Klinik Ottakring

Vienna, State of Vienna 1160

Austria

Universitätsklinik für Innere Medizin V Innsbruck

Innsbruck, 6020

Austria

Uniklinikum Salzburg

Salzburg, 5020

Austria

Medizinische Universität Wien

Vienna, 1090

Austria

Grand Hôpital de Charleroi

Gilly, Hainaut 6060

Belgium

CHU UCL Namur (site Godinne)

Yvoir, Namur 5530

Belgium

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

Salvador, Estado de Bahia 41253-190

Brazil

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

Porto Alegre, Rio Grande do Sul 90110-270

Brazil

Centro de Pesquisa Clínica - Área Administrativa

Porto Alegre, Rio Grande do Sul 90850-170

Brazil

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul 90880-480

Brazil

BP - A Beneficencia Portuguesa de São Paulo

São Paulo, São Paulo 01321-001

Brazil

Clínica Médica São Germano LTDA

SP, São Paulo 04537-080

Brazil

Hospital Américas Medical City

Rio de Janeiro, 22775001

Brazil

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, 22793-080

Brazil

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

São Paulo, 01232-010

Brazil

IDOR Ensino e Pesquisa

São Paulo, 01401-002.

Brazil

HU UNIFESP / SPDM - Hospital São Paulo

São Paulo, 04024-002

Brazil

Universidade Federal de Sao Paulo

São Paulo, 04024-002

Brazil

Clínica Médica São Germano S/S Ltda

São Paulo, 04537-080

Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, 04543-000

Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, 04544-000

Brazil

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia B3H 2Y9

Canada

Hamilton Health Sciences-Juravinski Cancer Centre

Hamilton, Ontario L8V5C2

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec H1T2M4

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Saskatoon Cancer Center

Saskatoon, Saskatchewan S7N4H4

Canada

Peking University Third Hospital

Beijing, Beijing Municipality 100191

China

Fujian Medical University Union Hospital

Fuzhou, Fujian 350001

China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong 510080

China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong 510515

China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510555

China

Shenzhen Second People's Hospital

Shenzhen, Guangdong 518035

China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei 050000

China

Henan Cancer Hospital

Zhengzhou, Henan 450008

China

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

Wuhan, Hubei 430030

China

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

Nanjing, Jiangsu 210008

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu 221006

China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

Jilin Province Cancer Hospital

Changchun, Jilin 130000

China

The First Hospital of Jilin University

Changchun, Jilin 130021

China

Shandong Provincial Hospital

Jinan, Shandong 250021

China

Jinan Central Hospital

Jinan, Shandong 250100

China

Institute of hematology&blood disease hospital

Tianjin, Tianjin Municipality 301636

China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang 310003

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000

China

Beijing Boren Hospital

Beijing, 100070

China

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, 100730

China

Chongqing University Cancer Hospital

Chongqing, 400030

China

Fakultní nemocnice Brno Bohunice

Brno, Brno-m?sto 625 00

Czechia

Fakultni Nemocnice Plzen

Plzen - Lochotin, Plzeň Region 304 60

Czechia

Fakultni poliklinika

Prague, Praha 2 120 00

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni nemocnice Olomouc

Olomouc, 779 00

Czechia

Fakultni nemocnice Ostrava

Ostrava-Poruba, 708 52

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 12808

Czechia

Kuopion Yliopistollinen Sairaala

Kuopio, Northern Savonia 70210

Finland

Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa 33520

Finland

Turku University Hospital

Turku, Southwest Finland 20520

Finland

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

Helsinki, 00029

Finland

Oulun yliopistollinen sairaala

Oulu, 90220

Finland

Tampereen yliopistollinen sairaala

Tampere, 33520

Finland

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, Limousin 87042

France

Hopital Claude Huriez - CHU de Lille

Lille, NORD 59000

France

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

Nantes, 44093

France

Hopital Necker

Paris, 75015

France

Hôpital Saint Antoine

Paris, 75571

France

Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

Pierre-Bénite, 69495

France

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

Poitiers, 86021

France

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

Toulouse, 31059

France

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg 89081

Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria 97080

Germany

Charité Universitätsmedizin Berlin

Berlin, 12203

Germany

Staedtisches Klinikum Braunschweig gGmbH

Braunschweig, 38114

Germany

Klinikum Chemnitz gGMbH

Chemnitz, 09116

Germany

Universitätsklinikum rechts der Isar, Technische Universität München (TUM)

München, 81675

Germany

Evangelismos General Hospital of Athens

Athens, Attikí 106 76

Greece

Radiology vendor

Athens, Attikí 115 25

Greece

Alexandra General Hospital of Athens

Athens, Attikí 115 28

Greece

Theageneio Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía 546 39

Greece

University General Hospital of Ioannina

Ioannina,

Greece

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

Meldola, Emilia-Romagna 47014

Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122

Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy 20900

Italy

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

Milan, Milan 20153

Italy

Policlinico "G. Rodolico"

Catania, Sicily 95123

Italy

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

Bologna, 40138

Italy

IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)

Genova, 16132

Italy

AOU Policlinico Umberto I

Roma, 00161

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Nagoya City University Hospital

Nagoya, Aichi-ken 467-8602

Japan

University of Fukui Hospital

Yoshida-gun, Fukui 910-1193

Japan

National Hospital Organization Shibukawa Medical Center

Shibukawa, Gunma 377-0280

Japan

Iwate Medical University Hospital

Yahaba-cho, Iwate 028-3695

Japan

Tohoku University Hospital

Sendai, Miyagi 980-8574

Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka 411-8777

Japan

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo 150-8935

Japan

Akita University Hospital

Akita, 010-8543

Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395

Japan

Kagoshima University Hospital

Kagoshima, 890-8520

Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860-0008

Japan

Nagasaki University Hospital

Nagasaki, 852-8501

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Osaka Metropolitan University Hospital

Osaka, 545-8586

Japan

Tokushima University Hospital

Tokushima, 770-8503

Japan

Yamagata University Hospital

Yamagata, 990-9585

Japan

Hematológica Alta Especialidad SC, consultorio 830

Colonia Valle de Las Palmas, México 52787

Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León 66460

Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, 68020

Mexico

Instituto Veracruzano en Investigación Clínica S.C.

Veracruz, 91851

Mexico

Erasmus Universitair Medisch Centrum

Rotterdam, South Holland 3015 GD

Netherlands

Maastricht University Medical Center

Maastricht, 6229 HX

Netherlands

North Shore Hospital

Auckland, 0622

New Zealand

Labtests Auckland Ltd.

Auckland, 1060

New Zealand

Aotearoa Clinical Trials

Auckland, 2025

New Zealand

Waikato District Health Board, Waikato Hospital

Hamilton, 3204

New Zealand

TRG Imaging

Milford, 0620

New Zealand

Pacific Radiology

Newtown, 6021

New Zealand

Broadway Radiology

Palmerston North, 4410

New Zealand

Palmerston North Hospital

Roslyn, 4414

New Zealand

Pharmacy on Shakespeare

Takapuna, 0620

New Zealand

Capital, Coast and Hutt Valley District - Wellington Regional Hospital

Wellington, 6021

New Zealand

Haukeland Universitetssjukehus

Bergen, Hordaland 5021

Norway

Stavanger Universitetssykehus

Stavanger, Rogaland 4021

Norway

Oslo Universitetssykehus Ullevål

Oslo, 0450

Norway

St Olavs Hospital

Trondheim, 7030

Norway

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

Bydgoszcz, 85-168

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569

Poland

Centrum Medyczne Pratia Poznan

Skorzewo, 60-185

Poland

Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny

Warsaw, 02-097

Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-367

Poland

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeonranamdo 58128

South Korea

Pusan National University Hospital

Busan, Pusan-kwangyǒkshi 49241

South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul] 03080

South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul] 06351

South Korea

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

Seoul, Seoul-teukbyeolsi [seoul] 06591

South Korea

Kyungpook National University Hospital

Daegu, Taegu-kwangyǒkshi 41944

South Korea

Gachon University Gil Medical Center

Incheon, 21565

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruna 15706

Spain

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908

Spain

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona 08221

Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria 39008

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitario de Toledo

Toledo, Other 45007

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clinic Barcelona

Barcelona, 08036

Spain

Hospital Universitari De Girona Doctor Josep Trueta

Girona, 17007

Spain

Hospital Universitario La Princesa

Madrid, 28006

Spain

Hospital Universitario Madrid Sanchinarro

Madrid, 28050

Spain

Hospital Universitario de Salamanca

Salamanca, 37007

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Universitario y Politecnico La Fe

Valencia, 46026

Spain

Skånes Universitetssjukhus Lund

Lund, Skåne LÄN [se-12] 22185

Sweden

Södra Älvsborg Sjukhus

Borås, 501 82

Sweden

Falu Lasarett

Falun, 791 82

Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, 41345

Sweden

Sunderby Sjukhus

Luleå, 971 80

Sweden

Universitetssjukhuset Örebro

Örebro, Örebro LÄN [se-18] 701 85

Sweden

Läkemedelsberedningen

Linköping, Östergötlands LÄN [se-05] 581 85

Sweden

Universitetssjukhuset i Linköping

Linköping, Östergötlands LÄN [se-05] 581 85

Sweden

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung City, 83301

Taiwan

China Medical University Hospital

Taichung, 40447

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi

Istanbul, İ̇stanbul 34093

Turkey (Türkiye)

Medipol Mega Universite Hastanesi

Istanbul, İ̇stanbul 34214

Turkey (Türkiye)

Acibadem Universitesi Atakent Hastanesi

Istanbul, İ̇stanbul 34303

Turkey (Türkiye)

Ege Universitesi Hastanesi

Izmir, İ̇zmir 35100

Turkey (Türkiye)

Dokuz Eylul Universitesi Hastanesi

Izmir, İ̇zmir 35340

Turkey (Türkiye)

Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

Adana, 01240

Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals

Ankara, 06100

Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

Ankara, 06200

Turkey (Türkiye)

Akdeniz Universitesi Hastanesi

Antalya, 07070

Turkey (Türkiye)

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

Gaziantep, 27310

Turkey (Türkiye)

Sisli Florence Nightingale Hastanesi

Istanbul, 34381

Turkey (Türkiye)

Erciyes Universitesi Tıp Fakultesi Hastaneleri

Kayseri, 38030

Turkey (Türkiye)

Özel Anadolu Sağlık Merkezi

Kocaeli, 41400

Turkey (Türkiye)

Inonu Universitesi Turgut Ozal Tıp Merkezi

Malatya, 44280

Turkey (Türkiye)

Royal Bournemouth Hospital

Bournemouth, Dorset BH7 7DW

United Kingdom

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire OX3 7LE

United Kingdom

University Hospital of Wales

Cardiff, South Glamorgan CF14 4XW

United Kingdom

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED

United Kingdom

Kent and Canterbury Hospital

Canterbury, CT1 3NG

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom