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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 Regional Medical Center

Fresno, California 93721

United States

UCHealth Poudre Valley Hospital

Fort Collins, Colorado 80524

United States

UCHealth Greeley Hospital

Greeley, Colorado 80634

United States

Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida 33180

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

University of Miami Hospital and Clinics

Miami, Florida 33136

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

Hospital Universitario Austral

Presidente Derqui, Buenos Aires B1629AHJ

Argentina

Pindara Private Hospital

Benowa, Queensland 4217

Australia

QScan Radiology Clinics

Clayfield, Queensland 4011

Australia

Gallipoli Medical Research Foundation

Greenslopes, Queensland 4120

Australia

Slade Pharmacy

Richmond, Victoria 3121

Australia

Linear Clinical Research

Perth, Western Australia 6009

Australia

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

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul 90880-480

Brazil

Clínica Médica São Germano LTDA

SP, São Paulo 04537-080

Brazil

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, 22793-080

Brazil

HU UNIFESP / SPDM - Hospital São 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

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec H1T2M4

Canada

Saskatoon Cancer Center

Saskatoon, Saskatchewan S7N4H4

Canada

Fujian Medical University Union Hospital

Fuzhou, Fujian 350001

China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong 510515

China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510555

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

Shandong Provincial Hospital

Jinan, Shandong 250021

China

Institute of hematology&blood disease hospital

Tianjin, Tianjin Municipality 301636

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

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

Helsinki, 00029

Finland

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, Limousin 87042

France

Hôpital Saint Antoine

Paris, 75571

France

Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

Pierre-Bénite, 69495

France

Charité Universitätsmedizin Berlin

Berlin, 12203

Germany

Universitätsklinikum rechts der Isar, Technische Universität München (TUM)

München, 81675

Germany

Alexandra General Hospital of Athens

Athens, Attikí 115 28

Greece

Theageneio Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía 546 39

Greece

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122

Italy

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

Bologna, 40138

Italy

National Hospital Organization Shibukawa Medical Center

Shibukawa, Gunma 377-0280

Japan

Tohoku University Hospital

Sendai, Miyagi 980-8574

Japan

Akita University Hospital

Akita, 010-8543

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

Yamagata University Hospital

Yamagata, 990-9585

Japan

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León 66460

Mexico

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

Palmerston North Hospital

Roslyn, 4414

New Zealand

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

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569

Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-367

Poland

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908

Spain

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona 08221

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 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

Skånes Universitetssjukhus Lund

Lund, Skåne LÄN [se-12] 22185

Sweden

Falu Lasarett

Falun, 791 82

Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, 41345

Sweden

Universitetssjukhuset Örebro

Örebro, Örebro LÄN [se-18] 701 85

Sweden

China Medical University Hospital

Taichung, 40447

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Ege Universitesi Hastanesi

Izmir, İ̇zmir 35100

Turkey (Türkiye)

Dokuz Eylul Universitesi Hastanesi

Izmir, İ̇zmir 35340

Turkey (Türkiye)

Akdeniz Universitesi Hastanesi

Antalya, 07070

Turkey (Türkiye)

University Hospital of Wales

Cardiff, South Glamorgan CF14 4XW

United Kingdom