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