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

Description

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.

Interventions

• Elranatamab (Drug)
  subcutaneous
• Daratumumab (Drug)
  Daratumumab / hyaluronidase, subcutaneous
• Pomalidomide (Drug)
  oral
• Dexamethasone (Drug)
  oral

Eligibility criteria

Conditions

Locations

• Clovis Community Medical Center — Clovis, California, United States
• Community Cancer Institute — Clovis, California, United States
• University of California San Francisco — Fresno, California, United States
• Community Regional Medical Center — Fresno, California, United States
• UCHealth Poudre Valley Hospital — Fort Collins, Colorado, United States
• UCHealth Harmony — Fort Collins, Colorado, United States
• UCHealth Greeley Hospital — Greeley, Colorado, United States
• UCHealth - Medical Center of the Rockies — Loveland, Colorado, United States
• Sylvester Comprehensive Cancer Center - Aventura — Aventura, Florida, United States
• Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center — Coral Gables, Florida, United States
• Sylvester Comprehensive Cancer Center - Coral Springs — Coral Springs, Florida, United States
• University of Miami Hospital and Clinics - Deerfield Beach — Deerfield Beach, Florida, United States
• Sylvester Comprehensive Cancer Center - Hollywood — Hollywood, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• University of Miami Hospital and Clinics — Miami, Florida, United States
• Sylvester Comprehensive Cancer Center - Kendall — Miami, Florida, United States
• Sylvester Comprehensive Cancer Center - Plantation — Plantation, Florida, United States
• East Jefferson General Hospital — Metairie, Louisiana, United States
• MSK Basking Ridge — Basking Ridge, New Jersey, United States
• MSK Monmouth — Middletown, New Jersey, United States
• MSK Bergen — Montvale, New Jersey, United States
• MSK Commack — Commack, New York, United States
• MSK Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States
• Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York, United States
• MSK Nassau — Uniondale, New York, United States
• Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• FUNDALEU - Fundacion para combatir la Leucemia — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• FUNDALEU -Fundación para combatir la leucemia — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• FUNDALEU — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Hospital Italiano de La Plata — La Plata, Buenos Aires, Argentina
• Hospital Universitario Austral — Presidente Derqui, Buenos Aires, Argentina
• Sanatorio de La Mujer — Rosario, Santa Fe Province, Argentina
• Pindara Private Hospital — Benowa, Queensland, Australia
• QScan Radiology Clinics — Clayfield, Queensland, Australia
• Gallipoli Medical Research Foundation — Greenslopes, Queensland, Australia
• Greenslopes Private Hospital — Greenslopes, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Epworth Freemasons — East Melbourne, Victoria, Australia
• St Vincent's Hospital (Melbourne) — Fitzroy, Victoria, Australia
• Barwon Health — Geelong, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Epworth Healthcare — Richmond, Victoria, Australia
• Slade Pharmacy — Richmond, Victoria, Australia
• Linear Clinical Research — Perth, Western Australia, Australia
• Universitätsklinikum Krems — Krems, Lower Austria, Austria
• Klinik Ottakring — Vienna, State of Vienna, Austria
• Universitätsklinik für Innere Medizin V Innsbruck — Innsbruck, Austria
• Uniklinikum Salzburg — Salzburg, Austria
• Medizinische Universität Wien — Vienna, Austria
• Grand Hôpital de Charleroi — Gilly, Hainaut, Belgium
• CHU UCL Namur (site Godinne) — Yvoir, Namur, Belgium
• Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador — Salvador, Estado de Bahia, Brazil
• Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa — Porto Alegre, Rio Grande do Sul, Brazil
• Centro de Pesquisa Clínica - Área Administrativa — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital Mae de Deus — Porto Alegre, Rio Grande do Sul, Brazil
• BP - A Beneficencia Portuguesa de São Paulo — São Paulo, São Paulo, Brazil
• Clínica Médica São Germano LTDA — SP, São Paulo, Brazil
• Hospital Américas Medical City — Rio de Janeiro, Brazil
• Instituto de Educação, Pesquisa e Gestão em Saúde — Rio de Janeiro, Brazil
• ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis — São Paulo, Brazil
• IDOR Ensino e Pesquisa — São Paulo, Brazil
• HU UNIFESP / SPDM - Hospital São Paulo — São Paulo, Brazil
• Universidade Federal de Sao Paulo — São Paulo, Brazil
• Clínica Médica São Germano S/S Ltda — São Paulo, Brazil
• Instituto D'Or de Pesquisa e Ensino (IDOR) — São Paulo, Brazil
• Instituto D'Or de Pesquisa e Ensino (IDOR) — São Paulo, Brazil
• Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• QEII Health Sciences Centre - Victoria General Site — Halifax, Nova Scotia, Canada
• Hamilton Health Sciences-Juravinski Cancer Centre — Hamilton, Ontario, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• CIUSSS de l'Est-de-l'Île-de-Montréal — Montreal, Quebec, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Saskatoon Cancer Center — Saskatoon, Saskatchewan, Canada
• Peking University Third Hospital — Beijing, Beijing Municipality, China
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• Jilin Province Cancer Hospital — Changchun, Jilin, China
• The First Hospital of Jilin University — Changchun, Jilin, China
• Shandong Provincial Hospital — Jinan, Shandong, China
• Jinan Central Hospital — Jinan, Shandong, China
• Institute of hematology&blood disease hospital — Tianjin, Tianjin Municipality, China
• The First Affiliated Hospital, Zhejiang University — Hangzhou, Zhejiang, China
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
• Beijing Boren Hospital — Beijing, China
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, China
• Chongqing University Cancer Hospital — Chongqing, China
• Fakultní nemocnice Brno Bohunice — Brno, Brno-m?sto, Czechia
• Fakultni Nemocnice Plzen — Plzen - Lochotin, Plzeň Region, Czechia
• Fakultni poliklinika — Prague, Praha 2, Czechia
• Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia
• Fakultni nemocnice Olomouc — Olomouc, Czechia
• Fakultni nemocnice Ostrava — Ostrava-Poruba, Czechia
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia
• Kuopion Yliopistollinen Sairaala — Kuopio, Northern Savonia, Finland
• Tampereen yliopistollinen sairaala — Tampere, Pirkanmaa, Finland
• Turku University Hospital — Turku, Southwest Finland, Finland
• Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) — Helsinki, Finland
• Oulun yliopistollinen sairaala — Oulu, Finland
• Tampereen yliopistollinen sairaala — Tampere, Finland
• Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren — Limoges, Limousin, France
• Hopital Claude Huriez - CHU de Lille — Lille, NORD, France
• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes, France
• Hopital Necker — Paris, France
• Hôpital Saint Antoine — Paris, France
• Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique — Pierre-Bénite, France
• CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie — Poitiers, France
• Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE — Toulouse, France
• Universitaetsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany
• Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany
• Charité Universitätsmedizin Berlin — Berlin, Germany
• Staedtisches Klinikum Braunschweig gGmbH — Braunschweig, Germany
• Klinikum Chemnitz gGMbH — Chemnitz, Germany
• Universitätsklinikum rechts der Isar, Technische Universität München (TUM) — München, Germany
• Evangelismos General Hospital of Athens — Athens, Attikí, Greece
• Radiology vendor — Athens, Attikí, Greece
• Alexandra General Hospital of Athens — Athens, Attikí, Greece
• Theageneio Cancer Hospital of Thessaloniki — Thessaloniki, Kentrikí Makedonía, Greece
• University General Hospital of Ioannina — Ioannina, Greece
• IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola, Emilia-Romagna, Italy
• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan, Lombardy, Italy
• Fondazione IRCCS San Gerardo dei Tintori — Monza, Lombardy, Italy
• ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra) — Milan, Milan, Italy
• Policlinico "G. Rodolico" — Catania, Sicily, Italy
• IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola — Bologna, Italy
• IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM) — Genova, Italy
• AOU Policlinico Umberto I — Roma, Italy
• Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy
• Nagoya City University Hospital — Nagoya, Aichi-ken, Japan
• University of Fukui Hospital — Yoshida-gun, Fukui, Japan
• National Hospital Organization Shibukawa Medical Center — Shibukawa, Gunma, Japan
• Iwate Medical University Hospital — Yahaba-cho, Iwate, Japan
• Tohoku University Hospital — Sendai, Miyagi, Japan
• Shizuoka Cancer Center — Sunto-gun, Shizuoka, Japan
• Japanese Red Cross Medical Center — Shibuya-ku, Tokyo, Japan
• Akita University Hospital — Akita, Japan
• National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan
• Kagoshima University Hospital — Kagoshima, Japan
• National Hospital Organization Kumamoto Medical Center — Kumamoto, Japan
• Nagasaki University Hospital — Nagasaki, Japan
• National Hospital Organization Okayama Medical Center — Okayama, Japan
• Osaka Metropolitan University Hospital — Osaka, Japan
• Tokushima University Hospital — Tokushima, Japan
• Yamagata University Hospital — Yamagata, Japan
• Hematológica Alta Especialidad SC, consultorio 830 — Colonia Valle de Las Palmas, México, Mexico
• Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey, Nuevo León, Mexico
• Centro de Investigacion Clinica de Oaxaca — Oaxaca City, Mexico
• Instituto Veracruzano en Investigación Clínica S.C. — Veracruz, Mexico
• Erasmus Universitair Medisch Centrum — Rotterdam, South Holland, Netherlands
• Maastricht University Medical Center — Maastricht, Netherlands
• North Shore Hospital — Auckland, New Zealand
• Labtests Auckland Ltd. — Auckland, New Zealand
• Aotearoa Clinical Trials — Auckland, New Zealand
• Waikato District Health Board, Waikato Hospital — Hamilton, New Zealand
• TRG Imaging — Milford, New Zealand
• Pacific Radiology — Newtown, New Zealand
• Broadway Radiology — Palmerston North, New Zealand
• Palmerston North Hospital — Roslyn, New Zealand
• Pharmacy on Shakespeare — Takapuna, New Zealand
• Capital, Coast and Hutt Valley District - Wellington Regional Hospital — Wellington, New Zealand
• Haukeland Universitetssjukehus — Bergen, Hordaland, Norway
• Stavanger Universitetssykehus — Stavanger, Rogaland, Norway
• Oslo Universitetssykehus Ullevål — Oslo, Norway
• St Olavs Hospital — Trondheim, Norway
• Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii — Bydgoszcz, Poland
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
• Pratia Onkologia Katowice — Katowice, Poland
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland
• Centrum Medyczne Pratia Poznan — Skorzewo, Poland
• Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny — Warsaw, Poland
• Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw, Poland
• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
• Chonnam National University Hwasun Hospital — Hwasun-gun, Jeonranamdo, South Korea
• Pusan National University Hospital — Busan, Pusan-kwangyǒkshi, South Korea
• Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
• Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul], South Korea
• The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
• Kyungpook National University Hospital — Daegu, Taegu-kwangyǒkshi, South Korea
• Gachon University Gil Medical Center — Incheon, South Korea
• Asan Medical Center — Seoul, South Korea
• Complejo Hospitalario Universitario de Santiago — Santiago de Compostela, A Coruna, Spain
• Institut Català d'Oncologia - L'Hospitalet — L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain
• Hospital Universitari Mutua Terrassa — Terrassa, Barcelona, Spain
• Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain
• Hospital Universitario de Toledo — Toledo, Other, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Clinic Barcelona — Barcelona, Spain
• Hospital Universitari De Girona Doctor Josep Trueta — Girona, Spain
• Hospital Universitario La Princesa — Madrid, Spain
• Hospital Universitario Madrid Sanchinarro — Madrid, Spain
• Hospital Universitario de Salamanca — Salamanca, Spain
• Hospital Universitario Virgen Del Rocio — Seville, Spain
• Hospital Universitario y Politecnico La Fe — Valencia, Spain
• Skånes Universitetssjukhus Lund — Lund, Skåne LÄN [se-12], Sweden
• Södra Älvsborg Sjukhus — Borås, Sweden
• Falu Lasarett — Falun, Sweden
• Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden
• Sunderby Sjukhus — Luleå, Sweden
• Universitetssjukhuset Örebro — Örebro, Örebro LÄN [se-18], Sweden
• Läkemedelsberedningen — Linköping, Östergötlands LÄN [se-05], Sweden
• Universitetssjukhuset i Linköping — Linköping, Östergötlands LÄN [se-05], Sweden
• Chang Gung Memorial Hospital at Kaohsiung — Kaohsiung City, Taiwan
• China Medical University Hospital — Taichung, Taiwan
• National Cheng Kung University Hospital — Tainan, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan
• Taipei Veterans General Hospital — Taipei, Taiwan
• Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi — Istanbul, İ̇stanbul, Turkey (Türkiye)
• Medipol Mega Universite Hastanesi — Istanbul, İ̇stanbul, Turkey (Türkiye)
• Acibadem Universitesi Atakent Hastanesi — Istanbul, İ̇stanbul, Turkey (Türkiye)
• Ege Universitesi Hastanesi — Izmir, İ̇zmir, Turkey (Türkiye)
• Dokuz Eylul Universitesi Hastanesi — Izmir, İ̇zmir, Turkey (Türkiye)
• Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi — Adana, Turkey (Türkiye)
• Ankara University Health Practice and Research Hospitals — Ankara, Turkey (Türkiye)
• Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi — Ankara, Turkey (Türkiye)
• Akdeniz Universitesi Hastanesi — Antalya, Turkey (Türkiye)
• Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi — Gaziantep, Turkey (Türkiye)
• Sisli Florence Nightingale Hastanesi — Istanbul, Turkey (Türkiye)
• Erciyes Universitesi Tıp Fakultesi Hastaneleri — Kayseri, Turkey (Türkiye)
• Özel Anadolu Sağlık Merkezi — Kocaeli, Turkey (Türkiye)
• Inonu Universitesi Turgut Ozal Tıp Merkezi — Malatya, Turkey (Türkiye)
• Royal Bournemouth Hospital — Bournemouth, Dorset, United Kingdom
• Churchill Hospital, Oxford University Hospitals NHS Foundation Trust — Oxford, Oxfordshire, United Kingdom
• University Hospital of Wales — Cardiff, South Glamorgan, United Kingdom
• Bristol Haematology and Oncology Centre — Bristol, United Kingdom
• Kent and Canterbury Hospital — Canterbury, United Kingdom
• The Christie NHS Foundation Trust — Manchester, United Kingdom