| Condition or Disease | Intervention/Treatment |
|---|---|
Multiple Myeloma | Drug: ElranatamabDrug: ElranatamabDrug: ElranatamabDrug: DaratumumabDrug: ElranatamabDrug: Elranatamab |
ClinicalTrials.gov processed this data on August 2026. Link to the current ClinicalTrials.gov record .
| Condition or Disease | Intervention/Treatment |
|---|---|
Multiple Myeloma | Drug: ElranatamabDrug: ElranatamabDrug: ElranatamabDrug: DaratumumabDrug: ElranatamabDrug: Elranatamab |
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 893 participants |
| Design Allocation | Randomized |
| Interventional Model | Factorial Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | October 3, 2021 |
| Actual Primary Completion Date | February 25, 2026 |
| Actual Study Completion Date | 9mos 3d from now |
| Group/Cohort | Intervention/Treatment |
|---|---|
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| Ages Eligible for Study | (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| 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. |
| Sponsors and Collaborators | Pfizer |
|---|---|
| Locations | Clovis Community Medical Center | Clovis California, United States, 93611Community Cancer Institute | Clovis California, United States, 93611University of California San Francisco | Fresno California, United States, 93701Community Regional Medical Center | Fresno California, United States, 93721UCHealth Poudre Valley Hospital | Fort Collins Colorado, United States, 80524UCHealth Harmony | Fort Collins Colorado, United States, 80528UCHealth Greeley Hospital | Greeley Colorado, United States, 80634UCHealth - Medical Center of the Rockies | Loveland Colorado, United States, 80538Sylvester Comprehensive Cancer Center - Aventura | Aventura Florida, United States, 33180Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center | Coral Gables Florida, United States, 33146Sylvester Comprehensive Cancer Center - Coral Springs | Coral Springs Florida, United States, 33065University of Miami Hospital and Clinics - Deerfield Beach | Deerfield Beach Florida, United States, 33442Sylvester Comprehensive Cancer Center - Hollywood | Hollywood Florida, United States, 33021Sylvester Comprehensive Cancer Center | Miami Florida, United States, 33136University of Miami Hospital and Clinics | Miami Florida, United States, 33136Sylvester Comprehensive Cancer Center - Kendall | Miami Florida, United States, 33176Sylvester Comprehensive Cancer Center - Plantation | Plantation Florida, United States, 33324East Jefferson General Hospital | Metairie Louisiana, United States, 70006MSK Basking Ridge | Basking Ridge New Jersey, United States, 07920MSK Monmouth | Middletown New Jersey, United States, 07748MSK Bergen | Montvale New Jersey, United States, 07645MSK Commack | Commack New York, United States, 11725MSK Westchester | Harrison New York, United States, 10604Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | New York New York, United States, 10021Memorial Sloan Kettering Cancer Center - Main Campus | New York New York, United States, 10065MSK Nassau | Uniondale New York, United States, 11553Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming) | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, 1426FUNDALEU - Fundacion para combatir la Leucemia | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, C1114AANFUNDALEU -Fundación para combatir la leucemia | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1114AAPFUNDALEU | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1114AAPHospital Italiano de La Plata | La Plata Buenos Aires, Argentina, B1900XIHospital Universitario Austral | Presidente Derqui Buenos Aires, Argentina, B1629AHJSanatorio de La Mujer | Rosario Santa Fe Province, Argentina, S2000OREPindara Private Hospital | Benowa Queensland, Australia, 4217QScan Radiology Clinics | Clayfield Queensland, Australia, 4011Gallipoli Medical Research Foundation | Greenslopes Queensland, Australia, 4120Greenslopes Private Hospital | Greenslopes Queensland, Australia, 4120Princess Alexandra Hospital | Woolloongabba Queensland, Australia, 4102Epworth Freemasons | East Melbourne Victoria, Australia, 3002St Vincent's Hospital (Melbourne) | Fitzroy Victoria, Australia, 3065Barwon Health | Geelong Victoria, Australia, 3220The Alfred Hospital | Melbourne Victoria, Australia, 3004Epworth Healthcare | Richmond Victoria, Australia, 3121Slade Pharmacy | Richmond Victoria, Australia, 3121Linear Clinical Research | Perth Western Australia, Australia, 6009Universitätsklinikum Krems | Krems Lower Austria, Austria, 3500Klinik Ottakring | Vienna State of Vienna, Austria, 1160Universitätsklinik für Innere Medizin V Innsbruck | Innsbruck , Austria, 6020Uniklinikum Salzburg | Salzburg , Austria, 5020Medizinische Universität Wien | Vienna , Austria, 1090Grand Hôpital de Charleroi | Gilly Hainaut, Belgium, 6060CHU UCL Namur (site Godinne) | Yvoir Namur, Belgium, 5530Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador | Salvador Estado de Bahia, Brazil, 41253-190Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa | Porto Alegre Rio Grande do Sul, Brazil, 90110-270Centro de Pesquisa Clínica - Área Administrativa | Porto Alegre Rio Grande do Sul, Brazil, 90850-170Hospital Mae de Deus | Porto Alegre Rio Grande do Sul, Brazil, 90880-480BP - A Beneficencia Portuguesa de São Paulo | São Paulo São Paulo, Brazil, 01321-001Clínica Médica São Germano LTDA | SP São Paulo, Brazil, 04537-080Hospital Américas Medical City | Rio de Janeiro , Brazil, 22775001Instituto de Educação, Pesquisa e Gestão em Saúde | Rio de Janeiro , Brazil, 22793-080ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis | São Paulo , Brazil, 01232-010IDOR Ensino e Pesquisa | São Paulo , Brazil, 01401-002.HU UNIFESP / SPDM - Hospital São Paulo | São Paulo , Brazil, 04024-002Universidade Federal de Sao Paulo | São Paulo , Brazil, 04024-002Clínica Médica São Germano S/S Ltda | São Paulo , Brazil, 04537-080Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo , Brazil, 04543-000Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo , Brazil, 04544-000Arthur J.E. Child Comprehensive Cancer Centre | Calgary Alberta, Canada, T2N 5G2Cross Cancer Institute | Edmonton Alberta, Canada, T6G 1Z2QEII Health Sciences Centre - Victoria General Site | Halifax Nova Scotia, Canada, B3H 2Y9Hamilton Health Sciences-Juravinski Cancer Centre | Hamilton Ontario, Canada, L8V5C2Princess Margaret Cancer Centre | Toronto Ontario, Canada, M5G 2M9CIUSSS de l'Est-de-l'Île-de-Montréal | Montreal Quebec, Canada, H1T2M4Jewish General Hospital | Montreal Quebec, Canada, H3T 1E2Saskatoon Cancer Center | Saskatoon Saskatchewan, Canada, S7N4H4Peking University Third Hospital | Beijing Beijing Municipality, China, 100191Fujian Medical University Union Hospital | Fuzhou Fujian, China, 350001Guangdong Provincial People's Hospital | Guangzhou Guangdong, China, 510080Nanfang Hospital of Southern Medical University | Guangzhou Guangdong, China, 510515Sun Yat-sen University Cancer Center | Guangzhou Guangdong, China, 510555Shenzhen Second People's Hospital | Shenzhen Guangdong, China, 518035The Second Hospital of Hebei Medical University | Shijiazhuang Hebei, China, 050000Henan Cancer Hospital | Zhengzhou Henan, China, 450008Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan Hubei, China, 430030Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School | Nanjing Jiangsu, China, 210008The Affiliated Hospital of Xuzhou Medical University | Xuzhou Jiangsu, China, 221006The First Affiliated Hospital of Nanchang University | Nanchang Jiangxi, China, 330006Jilin Province Cancer Hospital | Changchun Jilin, China, 130000The First Hospital of Jilin University | Changchun Jilin, China, 130021Shandong Provincial Hospital | Jinan Shandong, China, 250021Jinan Central Hospital | Jinan Shandong, China, 250100Institute of hematology&blood disease hospital | Tianjin Tianjin Municipality, China, 301636The First Affiliated Hospital, Zhejiang University | Hangzhou Zhejiang, China, 310003The First Affiliated Hospital of Wenzhou Medical University | Wenzhou Zhejiang, China, 325000Beijing Boren Hospital | Beijing , China, 100070Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing , China, 100730Chongqing University Cancer Hospital | Chongqing , China, 400030Fakultní nemocnice Brno Bohunice | Brno Brno-m?sto, Czechia, 625 00Fakultni Nemocnice Plzen | Plzen - Lochotin Plzeň Region, Czechia, 304 60Fakultni poliklinika | Prague Praha 2, Czechia, 120 00Fakultni nemocnice Hradec Kralove | Hradec Králové , Czechia, 500 05Fakultni nemocnice Olomouc | Olomouc , Czechia, 779 00Fakultni nemocnice Ostrava | Ostrava-Poruba , Czechia, 708 52Vseobecna fakultni nemocnice v Praze | Prague , Czechia, 12808Kuopion Yliopistollinen Sairaala | Kuopio Northern Savonia, Finland, 70210Tampereen yliopistollinen sairaala | Tampere Pirkanmaa, Finland, 33520Turku University Hospital | Turku Southwest Finland, Finland, 20520Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) | Helsinki , Finland, 00029Oulun yliopistollinen sairaala | Oulu , Finland, 90220Tampereen yliopistollinen sairaala | Tampere , Finland, 33520Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren | Limoges Limousin, France, 87042Hopital Claude Huriez - CHU de Lille | Lille NORD, France, 59000Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu | Nantes , France, 44093Hopital Necker | Paris , France, 75015Hôpital Saint Antoine | Paris , France, 75571Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique | Pierre-Bénite , France, 69495CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie | Poitiers , France, 86021Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE | Toulouse , France, 31059Universitaetsklinikum Ulm | Ulm Baden-Wurttemberg, Germany, 89081Universitätsklinikum Würzburg | Würzburg Bavaria, Germany, 97080Charité Universitätsmedizin Berlin | Berlin , Germany, 12203Staedtisches Klinikum Braunschweig gGmbH | Braunschweig , Germany, 38114Klinikum Chemnitz gGMbH | Chemnitz , Germany, 09116Universitätsklinikum rechts der Isar, Technische Universität München (TUM) | München , Germany, 81675Evangelismos General Hospital of Athens | Athens Attikí, Greece, 106 76Radiology vendor | Athens Attikí, Greece, 115 25Alexandra General Hospital of Athens | Athens Attikí, Greece, 115 28Theageneio Cancer Hospital of Thessaloniki | Thessaloniki Kentrikí Makedonía, Greece, 546 39University General Hospital of Ioannina | Ioannina , Greece, IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" | Meldola Emilia-Romagna, Italy, 47014Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan Lombardy, Italy, 20122Fondazione IRCCS San Gerardo dei Tintori | Monza Lombardy, Italy, 20900ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra) | Milan Milan, Italy, 20153Policlinico "G. Rodolico" | Catania Sicily, Italy, 95123IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Bologna , Italy, 40138IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM) | Genova , Italy, 16132AOU Policlinico Umberto I | Roma , Italy, 00161Fondazione Policlinico Universitario Agostino Gemelli | Roma , Italy, 00168Nagoya City University Hospital | Nagoya Aichi-ken, Japan, 467-8602University of Fukui Hospital | Yoshida-gun Fukui, Japan, 910-1193National Hospital Organization Shibukawa Medical Center | Shibukawa Gunma, Japan, 377-0280Iwate Medical University Hospital | Yahaba-cho Iwate, Japan, 028-3695Tohoku University Hospital | Sendai Miyagi, Japan, 980-8574Shizuoka Cancer Center | Sunto-gun Shizuoka, Japan, 411-8777Japanese Red Cross Medical Center | Shibuya-ku Tokyo, Japan, 150-8935Akita University Hospital | Akita , Japan, 010-8543National Hospital Organization Kyushu Cancer Center | Fukuoka , Japan, 811-1395Kagoshima University Hospital | Kagoshima , Japan, 890-8520National Hospital Organization Kumamoto Medical Center | Kumamoto , Japan, 860-0008Nagasaki University Hospital | Nagasaki , Japan, 852-8501National Hospital Organization Okayama Medical Center | Okayama , Japan, 701-1192Osaka Metropolitan University Hospital | Osaka , Japan, 545-8586Tokushima University Hospital | Tokushima , Japan, 770-8503Yamagata University Hospital | Yamagata , Japan, 990-9585Hematológica Alta Especialidad SC, consultorio 830 | Colonia Valle de Las Palmas México, Mexico, 52787Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey Nuevo León, Mexico, 66460Centro de Investigacion Clinica de Oaxaca | Oaxaca City , Mexico, 68020Instituto Veracruzano en Investigación Clínica S.C. | Veracruz , Mexico, 91851Erasmus Universitair Medisch Centrum | Rotterdam South Holland, Netherlands, 3015 GDMaastricht University Medical Center | Maastricht , Netherlands, 6229 HXNorth Shore Hospital | Auckland , New Zealand, 0622Labtests Auckland Ltd. | Auckland , New Zealand, 1060Aotearoa Clinical Trials | Auckland , New Zealand, 2025Waikato District Health Board, Waikato Hospital | Hamilton , New Zealand, 3204TRG Imaging | Milford , New Zealand, 0620Pacific Radiology | Newtown , New Zealand, 6021Broadway Radiology | Palmerston North , New Zealand, 4410Palmerston North Hospital | Roslyn , New Zealand, 4414Pharmacy on Shakespeare | Takapuna , New Zealand, 0620Capital, Coast and Hutt Valley District - Wellington Regional Hospital | Wellington , New Zealand, 6021Haukeland Universitetssjukehus | Bergen Hordaland, Norway, 5021Stavanger Universitetssykehus | Stavanger Rogaland, Norway, 4021Oslo Universitetssykehus Ullevål | Oslo , Norway, 0450St Olavs Hospital | Trondheim , Norway, 7030Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii | Bydgoszcz , Poland, 85-168Uniwersyteckie Centrum Kliniczne | Gdansk , Poland, 80-214Pratia Onkologia Katowice | Katowice , Poland, 40-519Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan , Poland, 60-569Centrum Medyczne Pratia Poznan | Skorzewo , Poland, 60-185Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny | Warsaw , Poland, 02-097Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw , Poland, 50-367Seoul National University Bundang Hospital | Seongnam-si Gyeonggi-do, South Korea, 13620Chonnam National University Hwasun Hospital | Hwasun-gun Jeonranamdo, South Korea, 58128Pusan National University Hospital | Busan Pusan-kwangyǒkshi, South Korea, 49241Seoul National University Hospital | Seoul Seoul-teukbyeolsi [seoul], South Korea, 03080Samsung Medical Center | Seoul Seoul-teukbyeolsi [seoul], South Korea, 06351The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul Seoul-teukbyeolsi [seoul], South Korea, 06591Kyungpook National University Hospital | Daegu Taegu-kwangyǒkshi, South Korea, 41944Gachon University Gil Medical Center | Incheon , South Korea, 21565Asan Medical Center | Seoul , South Korea, 05505Complejo Hospitalario Universitario de Santiago | Santiago de Compostela A Coruna, Spain, 15706Institut Català d'Oncologia - L'Hospitalet | L'Hospitalet Del Llobregat Barcelona [barcelona], Spain, 08908Hospital Universitari Mutua Terrassa | Terrassa Barcelona, Spain, 08221Hospital Universitario Marqués de Valdecilla | Santander Cantabria, Spain, 39008Clinica Universidad de Navarra | Pamplona Navarre, Spain, 31008Hospital Universitario de Toledo | Toledo Other, Spain, 45007Hospital Universitari Vall d'Hebron | Barcelona , Spain, 08035Hospital Clinic Barcelona | Barcelona , Spain, 08036Hospital Universitari De Girona Doctor Josep Trueta | Girona , Spain, 17007Hospital Universitario La Princesa | Madrid , Spain, 28006Hospital Universitario Madrid Sanchinarro | Madrid , Spain, 28050Hospital Universitario de Salamanca | Salamanca , Spain, 37007Hospital Universitario Virgen Del Rocio | Seville , Spain, 41013Hospital Universitario y Politecnico La Fe | Valencia , Spain, 46026Skånes Universitetssjukhus Lund | Lund Skåne LÄN [se-12], Sweden, 22185Södra Älvsborg Sjukhus | Borås , Sweden, 501 82Falu Lasarett | Falun , Sweden, 791 82Sahlgrenska Universitetssjukhuset | Gothenburg , Sweden, 41345Sunderby Sjukhus | Luleå , Sweden, 971 80Universitetssjukhuset Örebro | Örebro Örebro LÄN [se-18], Sweden, 701 85Läkemedelsberedningen | Linköping Östergötlands LÄN [se-05], Sweden, 581 85Universitetssjukhuset i Linköping | Linköping Östergötlands LÄN [se-05], Sweden, 581 85Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung City , Taiwan, 83301China Medical University Hospital | Taichung , Taiwan, 40447National Cheng Kung University Hospital | Tainan , Taiwan, 704National Taiwan University Hospital | Taipei , Taiwan, 10002Taipei Veterans General Hospital | Taipei , Taiwan, 11217Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi | Istanbul İ̇stanbul, Turkey (Türkiye), 34093Medipol Mega Universite Hastanesi | Istanbul İ̇stanbul, Turkey (Türkiye), 34214Acibadem Universitesi Atakent Hastanesi | Istanbul İ̇stanbul, Turkey (Türkiye), 34303Ege Universitesi Hastanesi | Izmir İ̇zmir, Turkey (Türkiye), 35100Dokuz Eylul Universitesi Hastanesi | Izmir İ̇zmir, Turkey (Türkiye), 35340Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi | Adana , Turkey (Türkiye), 01240Ankara University Health Practice and Research Hospitals | Ankara , Turkey (Türkiye), 06100Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi | Ankara , Turkey (Türkiye), 06200Akdeniz Universitesi Hastanesi | Antalya , Turkey (Türkiye), 07070Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi | Gaziantep , Turkey (Türkiye), 27310Sisli Florence Nightingale Hastanesi | Istanbul , Turkey (Türkiye), 34381Erciyes Universitesi Tıp Fakultesi Hastaneleri | Kayseri , Turkey (Türkiye), 38030Özel Anadolu Sağlık Merkezi | Kocaeli , Turkey (Türkiye), 41400Inonu Universitesi Turgut Ozal Tıp Merkezi | Malatya , Turkey (Türkiye), 44280Royal Bournemouth Hospital | Bournemouth Dorset, United Kingdom, BH7 7DWChurchill Hospital, Oxford University Hospitals NHS Foundation Trust | Oxford Oxfordshire, United Kingdom, OX3 7LEUniversity Hospital of Wales | Cardiff South Glamorgan, United Kingdom, CF14 4XWBristol Haematology and Oncology Centre | Bristol , United Kingdom, BS2 8EDKent and Canterbury Hospital | Canterbury , United Kingdom, CT1 3NGThe Christie NHS Foundation Trust | Manchester , United Kingdom, M20 4BX |
| Investigators | Study Director: Pfizer CT.gov Call Center, Pfizer |
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