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Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: AbbVie
Summary
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Official title: A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
421
Start Date
2024-05-19
Completion Date
2027-12
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Etentamig
Intravenous (IV) Infusion
Carfilzomib
IV Infusion
Pomalidomide
Oral Capsule
Elotuzumab
IV Infusion
Selinexor
Oral Tablet
Bortezomib
Subcutaneous or IV Injection
Dexamethasone
Oral Tablet or IV Infusion
Locations (166)
University of Alabama at Birmingham - Main /ID# 261434
Birmingham, Alabama, United States
Mayo Clinic Hospital - Phoenix /ID# 263326
Phoenix, Arizona, United States
Alta Bates Summit Medical Center for Research /ID# 261438
Berkeley, California, United States
Providence - St. Jude Medical Center /ID# 262031
Fullerton, California, United States
VA Loma Linda Healthcare System /ID# 261015
Loma Linda, California, United States
Cedars-Sinai Medical Center /ID# 261008
Los Angeles, California, United States
Rocky Mountain Cancer Centers - Lone Tree /ID# 278320
Lone Tree, Colorado, United States
Mayo Clinic Hospital Jacksonville /ID# 263324
Jacksonville, Florida, United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230
Jacksonville, Florida, United States
Winship Cancer Institute of Emory University /ID# 262525
Atlanta, Georgia, United States
University of Illinois Hospital and Health Sciences System /ID# 246349
Chicago, Illinois, United States
Rush University Medical Center /ID# 265690
Chicago, Illinois, United States
Nancy W. Knowles Cancer Center /ID# 271361
Elmhurst, Illinois, United States
Springfield Clinic - First /ID# 262266
Springfield, Illinois, United States
Our Lady Of The Lake Regional Medical Center /ID# 272780
Baton Rouge, Louisiana, United States
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center /ID# 271535
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 261554
Boston, Massachusetts, United States
Regents of the University of Michigan /ID# 261577
Ann Arbor, Michigan, United States
Karmanos Cancer Institute - Detroit /ID# 266298
Detroit, Michigan, United States
Henry Ford Hospital /ID# 262704
Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891
Lansing, Michigan, United States
Mayo Clinic - Rochester /ID# 246228
Rochester, Minnesota, United States
University of Missouri Hospital /ID# 261553
Columbia, Missouri, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772
Omaha, Nebraska, United States
New York Cancer & Blood Specialists - Bay Shore /ID# 261524
Bay Shore, New York, United States
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953
New Hyde Park, New York, United States
New York Cancer and Blood Specialists - New York /ID# 262951
New York, New York, United States
Eastchester Center for Cancer Care /ID# 262952
The Bronx, New York, United States
University of North Carolina /ID# 259854
Chapel Hill, North Carolina, United States
Atrium Health Levine Cancer Institute /ID# 246199
Charlotte, North Carolina, United States
Duke University Medical Center /ID# 259694
Durham, North Carolina, United States
University Of Cincinnati Medical Center /ID# 246415
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus /ID# 246183
Cleveland, Ohio, United States
Oregon Medical Research Center /ID# 262335
Portland, Oregon, United States
Medical University of South Carolina /ID# 259692
Charleston, South Carolina, United States
University of Tennessee Health Science Center /ID# 261622
Memphis, Tennessee, United States
Baptist Memorial Hospital /ID# 270910
Memphis, Tennessee, United States
The West Clinic /ID# 262444
Memphis, Tennessee, United States
Vanderbilt University Medical Center /ID# 261621
Nashville, Tennessee, United States
Oncology Consultants /ID# 276774
Houston, Texas, United States
Texas Oncology - Northeast Texas /ID# 278304
Tyler, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 262792
Fairfax, Virginia, United States
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314
Norfolk, Virginia, United States
VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944
Richmond, Virginia, United States
Northwest Medical Specialties Tacoma /ID# 276281
Tacoma, Washington, United States
St George Hospital - Kogarah /ID# 261806
Kogarah, New South Wales, Australia
Liverpool Hospital /ID# 262159
Liverpool, New South Wales, Australia
Calvary Mater Newcastle /ID# 261804
Waratah, New South Wales, Australia
Princess Alexandra Hospital - Woolloongabba /ID# 261810
Woolloongabba, Queensland, Australia
Monash Health - Monash Medical Centre - Clayton /ID# 262158
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 261808
Fitzroy Melbourne, Victoria, Australia
Box Hill Hospital /ID# 262784
Melbourne, Victoria, Australia
Universitaetsklinikum Krems /ID# 261509
Krems, Lower Austria, Austria
Klinik Ottakring /ID# 245829
Vienna, State of Vienna, Austria
Medizinische Universitaet Graz /ID# 261908
Graz, Styria, Austria
Ordensklinikum Linz Elisabethinen /ID# 245609
Linz, Upper Austria, Austria
Algemeen Ziekenhuis klina /ID# 260856
Brasschaat, Antwerpen, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge /ID# 245345
Bruges, West-Vlaanderen, Belgium
University Health Network_Princess Margaret Cancer Centre /ID# 261566
Toronto, Ontario, Canada
Beijing Chaoyang Hospital,Capital Medical University /ID# 245533
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital East - Dongdan Campus /ID# 245545
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital /ID# 245558
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center /ID# 245542
Guangzhou, Guangdong, China
People's Hospital of Henan Province /ID# 260918
Zhengzhou, Henan, China
Henan Cancer Hospital /ID# 245536
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549
Wuhan, Hubei, China
Zhongda Hospital Southeast University /ID# 245563
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University /ID# 245544
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 245537
Nanchang, Jiangxi, China
First Affiliated Hospital of China Medical University /ID# 245547
Shenyang, Liaoning, China
Second Affiliated Hospital of Xian Jiaotong University /ID# 261255
Xi'an, Shaanxi, China
Shanghai Tongji Hospital /ID# 245539
Shanghai, Shanghai Municipality, China
Institute of Hematology and Blood Diseases Hospital /ID# 265702
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital /ID# 260851
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 245550
Wenzhou, Zhejiang, China
Fakultni Nemocnice Brno - Jihlavska /ID# 245689
Brno, Brno-mesto, Czechia
Fakultni Nemocnice Ostrava /ID# 245686
Ostrava, Ostrava-mesto, Czechia
Vseobecna Fakultni nemocnice v Praze /ID# 245691
Prague, Praha 17, Czechia
Fakultni nemocnice Hradec Kralove - Sokolska /ID# 245690
Hradec Králové, Czechia
Odense University Hospital /ID# 260924
Odense, Region Syddanmark, Denmark
Vejle Sygehus /ID# 260923
Vejle, Region Syddanmark, Denmark
CH Saint-Quentin /ID# 261856
Saint-Quentin, Aisne, France
Centre Hospitalier Regional d Orleans - Hopital de la Source /ID# 261854
Orléans, Loiret, France
Centre Hospitalier du Mans /ID# 261852
Le Mans, Sarthe, France
CH Henri Duffaut /ID# 261844
Avignon, Vaucluse, France
Universitaetsklinikum Freiburg /ID# 262147
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Staedtisches Klinikum Karlsruhe /ID# 272377
Karlsruhe, Baden-Wurttemberg, Germany
Klinikum Chemnitz - Flemmingstrabe /ID# 273108
Chemnitz, Saxony, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689
Berlin, Germany
Centrum fuer Haematologie und Onkologie Bethanien /ID# 271982
Frankfurt am Main, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 260651
Hamburg, Germany
Alexandra General Hospital /ID# 240591
Athens, Attica, Greece
University General Hospital Attikon /ID# 240592
Chaïdári, Attica, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596
Athens, Greece
General University Hospital of Thessaloniki AXEPA /ID# 240595
Thessaloniki, Greece
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648
Győr, Győr-Moson-Sopron, Hungary
Semmelweis Egyetem /ID# 261646
Budapest, Hungary