Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT06158841
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
380 participants
INTERVENTIONAL
2024-05-19
2027-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
Carfilzomib
IV Infusion
Pomalidomide
Oral Capsule
Elotuzumab
IV Infusion
Selinexor
Oral Tablet
Bortezomib
Subcutaneous or IV Injection
Dexamethasone
Oral Tablet or IV Infusion
Etentamig
Participants will receive etentamig as a monotherapy.
Etentamig
Intravenous (IV) Infusion
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
* Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
* Urine M-protein \>= 200 mg/24 hours.
* In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
Exclusion Criteria
* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
* Central nervous system involvement of MM.
* Has received B-cell maturation antigen (BCMA)-targeted therapy.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
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
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 /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 /ID# 261810
Woolloongabba, Queensland, Australia
Monash Health - Monash Medical Centre /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
Medizinische Universitaet Graz /ID# 261908
Graz, Styria, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 245609
Linz, Upper Austria, Austria
Klinik Ottakring /ID# 245829
Vienna, Vienna, Austria
Algemeen Ziekenhuis klina /ID# 260856
Brasschaat, Antwerpen, Belgium
AZ 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
Fakultní Nemocnice Brno - Jihlavská /ID# 245689
Brno, Brno-mesto, Czechia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 245690
Hradec Králové, Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava /ID# 245686
Ostrava, Ostrava-mesto, Czechia
Vseobecna Fakultni Nemocnice v Praze /ID# 245691
Prague, Praha 17, 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 du Mans /ID# 261852
Le Mans, Sarthe, France
CH Henri Duffaut /ID# 261844
Avignon, Vaucluse, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854
Orléans, , France
Universitaetsklinikum Freiburg /ID# 262147
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Staedtisches Klinikum Karlsruhe /ID# 272377
Karlsruhe, Baden-Wurttemberg, Germany
Klinikum Chemnitz - Flemmingstraße /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
Athens, 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# 261647
Budapest, , Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 261646
Budapest, , Hungary
Shaare Zedek Medical Center /ID# 245681
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 245497
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 245495
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center. /ID# 245498
Petah Tikva, , Israel
ASST Ovest Milanese /ID# 256813
Legnano, Milano, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808
Turin, Piedmont, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810
Rome, Roma, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 256812
Ancona, , Italy
AOU Policlinico G. Rodolico - San Marco /ID# 256814
Catania, , Italy
Anjo Kosei Hospital /ID# 263434
Anjo, Aichi-ken, Japan
Nagoya City University Hospital /ID# 263320
Nagoya, Aichi-ken, Japan
Chiba University Hospital /ID# 262006
Chiba, Chiba, Japan
University of Fukui Hospital /ID# 264222
Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 264704
Fukuoka, Fukuoka, Japan
Gifu Municipal Hospital /ID# 263321
Gifu, Gifu, Japan
Gunma University Hospital /ID# 262580
Maebashi, Gunma, Japan
Chugoku Central Hospital /ID# 263431
Fukuyama, Hiroshima, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 265696
Amagasaki, Hyōgo, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 262585
Kyoto, Kyoto, Japan
Miyagi Cancer Center /ID# 265094
Natori-shi, Miyagi, Japan
Naha City Hospital /ID# 263972
Naha, Okinawa, Japan
The University of Osaka Hospital /ID# 263974
Suita-shi, Osaka, Japan
Saitama Prefectural Cancer Center /ID# 262586
Kitaadachi-gun, Saitama, Japan
Tokyo Metropolitan Komagome Hospital /ID# 277567
Bunkyo Ku, Tokyo, Japan
Japanese Red Cross Medical Center /ID# 261717
Shibuya-ku, Tokyo, Japan
University of Yamanashi Hospital /ID# 262912
Chuo-shi, Yamanashi, Japan
Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 260172
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168
Lublin, Lublin Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne /ID# 260169
Gdansk, Pomeranian Voivodeship, Poland
Fundacao Champalimaud /ID# 246258
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 246255
Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257
Porto, , Portugal
Hematology And Oncology Institute /ID# 272531
Manatí, , Puerto Rico
Auxilio Mutuo Cancer Center /ID# 272565
San Juan, , Puerto Rico
Alberts Cellular Therapy /ID# 245725
Pretoria, Gauteng, South Africa
Constantiaberg Haematology /ID# 261320
Cape Town, Western Cape, South Africa
Haemalife Inc. /ID# 245724
Kuils River, Western Cape, South Africa
Seoul National University Hospital /ID# 245491
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 245492
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493
Seoul, Seoul Teugbyeolsi, South Korea
Ulsan University Hospital /ID# 245490
Ulsan, Ulsan Gwang Yeogsi, South Korea
Yonsei University Health System Severance Hospital /ID# 245489
Seoul, , South Korea
Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398
Badalona, Barcelona, Spain
Complejo Hospitalario Universitario Ourense /ID# 246400
Ourense, Ourense, Spain
Hospital de Leon /ID# 261624
León, , Spain
Hospital General Universitario Gregorio Maranon /ID# 246401
Madrid, , Spain
Hospital Universitario de Salamanca /ID# 262218
Salamanca, , Spain
Hospital Universitario y Politecnico La Fe /ID# 261625
Valencia, , Spain
Helsingborgs Lasarett /ID# 262513
Helsingborg, Skåne County, Sweden
Uddevalla sjukhus /ID# 262034
Uddevalla, Västra Götaland County, Sweden
Falu Lasarett /ID# 262231
Falun, , Sweden
National Taiwan University Hospital /ID# 245482
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 245483
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 261142
Taichung, , Taiwan
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672
Ankara, , Turkey (Türkiye)
Antalya Egitim Ve Arastirma Hastanesi /ID# 261674
Antalya, , Turkey (Türkiye)
Trakya University Medical Facu /ID# 261673
Edirne, Istanbul, , Turkey (Türkiye)
Istanbul Florence Nightingale Hospital /ID# 271543
Şişli, , Turkey (Türkiye)
Addenbrookes Hospital /ID# 261104
Cambridge, Cambridgeshire, United Kingdom
Western General Hospital - NHS Lothian /ID# 261106
Edinburgh, Edinburgh, City of, United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488
London, Greater London, United Kingdom
Nottingham City Hospital /ID# 261105
Nottingham, Nottinghamshire, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 261101
Leeds, West Yorkshire, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 262470
London, , United Kingdom
The Christie Hospital /ID# 261102
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2023-506668-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
M22-574
Identifier Type: -
Identifier Source: org_study_id