Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Start Date
5/19/2024
Completion Date
12/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Etentamig
Carfilzomib
Pomalidomide
Elotuzumab
Selinexor
Bortezomib
Dexamethasone
Conditions
Locations
University of Alabama at Birmingham - Main /ID# 261434
Birmingham, Alabama 35233
United States
Mayo Clinic Hospital - Phoenix /ID# 263326
Phoenix, Arizona 85054
United States
Alta Bates Summit Medical Center for Research /ID# 261438
Berkeley, California 94705
United States
Providence - St. Jude Medical Center /ID# 262031
Fullerton, California 92835
United States
VA Loma Linda Healthcare System /ID# 261015
Loma Linda, California 92357
United States
Cedars-Sinai Medical Center /ID# 261008
Los Angeles, California 90048
United States
Rocky Mountain Cancer Centers - Lone Tree /ID# 278320
Lone Tree, Colorado 80124
United States
Mayo Clinic Hospital Jacksonville /ID# 263324
Jacksonville, Florida 32224
United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230
Jacksonville, Florida 32256
United States
Winship Cancer Institute of Emory University /ID# 262525
Atlanta, Georgia 30322
United States
University of Illinois Hospital and Health Sciences System /ID# 246349
Chicago, Illinois 60607
United States
Rush University Medical Center /ID# 265690
Chicago, Illinois 60612
United States
Nancy W. Knowles Cancer Center /ID# 271361
Elmhurst, Illinois 60126
United States
Springfield Clinic - First /ID# 262266
Springfield, Illinois 62702
United States
Our Lady Of The Lake Regional Medical Center /ID# 272780
Baton Rouge, Louisiana 70808
United States
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637
Bethesda, Maryland 20817
United States
Beth Israel Deaconess Medical Center /ID# 271535
Boston, Massachusetts 02215
United States
Dana-Farber Cancer Institute /ID# 261554
Boston, Massachusetts 02215
United States
Regents of the University of Michigan /ID# 261577
Ann Arbor, Michigan 48109-1276
United States
Karmanos Cancer Institute - Detroit /ID# 266298
Detroit, Michigan 48201
United States
Henry Ford Hospital /ID# 262704
Detroit, Michigan 48202
United States
Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891
Lansing, Michigan 48912
United States
Mayo Clinic - Rochester /ID# 246228
Rochester, Minnesota 55905-0001
United States
University of Missouri Hospital /ID# 261553
Columbia, Missouri 65212
United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772
Omaha, Nebraska 68130
United States
New York Cancer & Blood Specialists - Bay Shore /ID# 261524
Bay Shore, New York 11706
United States
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953
New Hyde Park, New York 11042
United States
New York Cancer and Blood Specialists - New York /ID# 262951
New York, New York 10028
United States
Eastchester Center for Cancer Care /ID# 262952
The Bronx, New York 10469
United States
University of North Carolina /ID# 259854
Chapel Hill, North Carolina 27514
United States
Atrium Health Levine Cancer Institute /ID# 246199
Charlotte, North Carolina 28204
United States
Duke University Medical Center /ID# 259694
Durham, North Carolina 27710
United States
University Of Cincinnati Medical Center /ID# 246415
Cincinnati, Ohio 45219
United States
Cleveland Clinic Main Campus /ID# 246183
Cleveland, Ohio 44195
United States
Oregon Medical Research Center /ID# 262335
Portland, Oregon 97239
United States
Medical University of South Carolina /ID# 259692
Charleston, South Carolina 29425
United States
University of Tennessee Health Science Center /ID# 261622
Memphis, Tennessee 38103
United States
Baptist Memorial Hospital /ID# 270910
Memphis, Tennessee 38120
United States
The West Clinic /ID# 262444
Memphis, Tennessee 38120
United States
Vanderbilt University Medical Center /ID# 261621
Nashville, Tennessee 37232-0011
United States
Oncology Consultants /ID# 276774
Houston, Texas 77030
United States
Texas Oncology - Northeast Texas /ID# 278304
Tyler, Texas 75702
United States
Virginia Cancer Specialists - Fairfax /ID# 262792
Fairfax, Virginia 22031
United States
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314
Norfolk, Virginia 23502
United States
VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944
Richmond, Virginia 23298
United States
Northwest Medical Specialties Tacoma /ID# 276281
Tacoma, Washington 98405
United States
St George Hospital - Kogarah /ID# 261806
Kogarah, New South Wales 2217
Australia
Liverpool Hospital /ID# 262159
Liverpool, New South Wales 2170
Australia
Calvary Mater Newcastle /ID# 261804
Waratah, New South Wales 2298
Australia
Princess Alexandra Hospital - Woolloongabba /ID# 261810
Woolloongabba, Queensland 4102
Australia
Monash Health - Monash Medical Centre - Clayton /ID# 262158
Clayton, Victoria 3168
Australia
St Vincent's Hospital Melbourne /ID# 261808
Fitzroy Melbourne, Victoria 3065
Australia
Box Hill Hospital /ID# 262784
Melbourne, Victoria 3128
Australia
Universitaetsklinikum Krems /ID# 261509
Krems, Lower Austria 3500
Austria
Klinik Ottakring /ID# 245829
Vienna, State of Vienna 1160
Austria
Medizinische Universitaet Graz /ID# 261908
Graz, Styria 8010
Austria
Ordensklinikum Linz Elisabethinen /ID# 245609
Linz, Upper Austria 4010
Austria
Algemeen Ziekenhuis klina /ID# 260856
Brasschaat, Antwerpen 2930
Belgium
Algemeen Ziekenhuis Sint-Jan Brugge /ID# 245345
Bruges, West-Vlaanderen 8000
Belgium
University Health Network_Princess Margaret Cancer Centre /ID# 261566
Toronto, Ontario M5G 2M9
Canada
Beijing Chaoyang Hospital,Capital Medical University /ID# 245533
Beijing, Beijing Municipality 100020
China
Peking Union Medical College Hospital East - Dongdan Campus /ID# 245545
Beijing, Beijing Municipality 100730
China
Fujian Medical University Union Hospital /ID# 245558
Fuzhou, Fujian 350001
China
Sun Yat-Sen University Cancer Center /ID# 245542
Guangzhou, Guangdong 510060
China
People's Hospital of Henan Province /ID# 260918
Zhengzhou, Henan 450003
China
Henan Cancer Hospital /ID# 245536
Zhengzhou, Henan 450008
China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549
Wuhan, Hubei 430022
China
Zhongda Hospital Southeast University /ID# 245563
Nanjing, Jiangsu 210009
China
The First Affiliated Hospital of Soochow University /ID# 245544
Suzhou, Jiangsu 215006
China
The First Affiliated Hospital of Nanchang University /ID# 245537
Nanchang, Jiangxi 330006
China
First Affiliated Hospital of China Medical University /ID# 245547
Shenyang, Liaoning 110001
China
Second Affiliated Hospital of Xian Jiaotong University /ID# 261255
Xi'an, Shaanxi 710004
China
Shanghai Tongji Hospital /ID# 245539
Shanghai, Shanghai Municipality 200065
China
Institute of Hematology and Blood Diseases Hospital /ID# 265702
Tianjin, Tianjin Municipality 300020
China
Tianjin Medical University General Hospital /ID# 260851
Tianjin, Tianjin Municipality 300052
China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883
Hangzhou, Zhejiang 310003
China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882
Hangzhou, Zhejiang 310020
China
The First Affiliated Hospital of Wenzhou Medical University /ID# 245550
Wenzhou, Zhejiang 325000
China
Fakultni Nemocnice Brno - Jihlavska /ID# 245689
Brno, Brno-mesto 625 00
Czechia
Fakultni Nemocnice Ostrava /ID# 245686
Ostrava, Ostrava-mesto 708 52
Czechia
Vseobecna Fakultni nemocnice v Praze /ID# 245691
Prague, Praha 17 128 00
Czechia
Fakultni nemocnice Hradec Kralove - Sokolska /ID# 245690
Hradec Králové, 500 05
Czechia
Odense University Hospital /ID# 260924
Odense, Region Syddanmark 5000
Denmark
Vejle Sygehus /ID# 260923
Vejle, Region Syddanmark 7100
Denmark
CH Saint-Quentin /ID# 261856
Saint-Quentin, Aisne 02321
France
Centre Hospitalier du Mans /ID# 261852
Le Mans, Sarthe 72037
France
CH Henri Duffaut /ID# 261844
Avignon, Vaucluse 84902
France
Centre Hospitalier Regional d Orleans - Hopital de la Source /ID# 261854
Orléans, 45067
France
Universitaetsklinikum Freiburg /ID# 262147
Freiburg im Breisgau, Baden-Wurttemberg 79106
Germany
Staedtisches Klinikum Karlsruhe /ID# 272377
Karlsruhe, Baden-Wurttemberg 76133
Germany
Klinikum Chemnitz - Flemmingstraße /ID# 273108
Chemnitz, Saxony 09116
Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689
Berlin, 12203
Germany
Centrum fuer Haematologie und Onkologie Bethanien /ID# 271982
Frankfurt am Main, 60389
Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 260651
Hamburg, 20246
Germany
Alexandra General Hospital /ID# 240591
Athens, Attica 11528
Greece
University General Hospital Attikon /ID# 240592
Chaïdári, Attica 12462
Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596
Athens, 10676
Greece
General University Hospital of Thessaloniki AXEPA /ID# 240595
Thessaloniki, 54636
Greece
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648
Győr, Győr-Moson-Sopron 9024
Hungary
Semmelweis Egyetem /ID# 261646
Budapest, 1085
Hungary
Semmelweis Egyetem /ID# 261647
Budapest, 1085
Hungary
Rabin Medical Center. /ID# 245498
Petah Tikva, Central District 4941492
Israel
Shaare Zedek Medical Center /ID# 245681
Jerusalem, Jerusalem 91031
Israel
The Chaim Sheba Medical Center /ID# 245497
Ramat Gan, Tel Aviv 5265601
Israel
Tel Aviv Sourasky Medical Center /ID# 245495
Tel Aviv, Tel Aviv 6423906
Israel
ASST Ovest Milanese /ID# 256813
Legnano, Milano 20025
Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808
Turin, Piedmont 10126
Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810
Rome, Roma 00161
Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 256812
Ancona, 60126
Italy
AOU Policlinico G. Rodolico - San Marco /ID# 256814
Catania, 95123
Italy
Anjo Kosei Hospital /ID# 263434
Anjo, Aichi-ken 446-8602
Japan
Nagoya City University Hospital /ID# 263320
Nagoya, Aichi-ken 467-8602
Japan
Chiba University Hospital /ID# 262006
Chiba, Chiba 260-8677
Japan
University of Fukui Hospital /ID# 264222
Yoshida-gun, Fukui 910-1104
Japan
Kyushu University Hospital /ID# 264704
Fukuoka, Fukuoka 812-8582
Japan
Gifu Municipal Hospital /ID# 263321
Gifu, Gifu 500-8323
Japan
Gunma University Hospital /ID# 262580
Maebashi, Gunma 371-8511
Japan
Chugoku Central Hospital /ID# 263431
Fukuyama, Hiroshima 720-0001
Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 265696
Amagasaki, Hyōgo 660-8550
Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 262585
Kyoto, Kyoto 602-8566
Japan
Miyagi Cancer Center /ID# 265094
Natori-shi, Miyagi 981-1293
Japan
Naha City Hospital /ID# 263972
Naha, Okinawa 902-0061
Japan
The University of Osaka Hospital /ID# 263974
Suita-shi, Osaka 565-0871
Japan
Saitama Prefectural Cancer Center /ID# 262586
Kitaadachi-gun, Saitama 362-0806
Japan
Tokyo Metropolitan Komagome Hospital /ID# 277567
Bunkyo Ku, Tokyo 113-8677
Japan
Japanese Red Cross Medical Center /ID# 261717
Shibuya-ku, Tokyo 150-8935
Japan
University of Yamanashi Hospital /ID# 262912
Chuo-shi, Yamanashi 409-3898
Japan
Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 260172
Wroclaw, Lower Silesian Voivodeship 50-556
Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168
Lublin, Lublin Voivodeship 20-081
Poland
Uniwersyteckie Centrum Kliniczne /ID# 260169
Gdansk, Pomeranian Voivodeship 80-214
Poland
Fundacao Champalimaud /ID# 246258
Lisbon, Lisbon District 1400-038
Portugal
Unidade Local de Saude de Santa Maria /ID# 246255
Lisbon, 1649-035
Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 246257
Porto, 4200-072
Portugal
Hematology And Oncology Institute /ID# 272531
Manati, 00674
Puerto Rico
Auxilio Mutuo Cancer Center /ID# 272565
San Juan, 00918
Puerto Rico
Alberts Cellular Therapy /ID# 245725
Pretoria, Gauteng 0044
South Africa
Constantiaberg Haematology /ID# 261320
Cape Town, Western Cape 7800
South Africa
Haemalife Inc. /ID# 245724
Kuils River, Western Cape 7580
South Africa
Seoul National University Hospital /ID# 245491
Seoul, Seoul Teugbyeolsi 03080
South Korea
Samsung Medical Center /ID# 245492
Seoul, Seoul Teugbyeolsi 06351
South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493
Seoul, Seoul Teugbyeolsi 06591
South Korea
Ulsan University Hospital /ID# 245490
Ulsan, Ulsan Gwang Yeogsi 44033
South Korea
Yonsei University Health System Severance Hospital /ID# 245489
Seoul, 03722
South Korea
Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398
Badalona, Barcelona 08916
Spain
Complejo Hospitalario Universitario Ourense /ID# 246400
Ourense, Ourense 32005
Spain
Hospital de Leon /ID# 261624
León, 24071
Spain
Hospital General Universitario Gregorio Maranon /ID# 246401
Madrid, 28007
Spain
Hospital Universitario de Salamanca /ID# 262218
Salamanca, 37711
Spain
Hospital Universitario y Politecnico La Fe /ID# 261625
Valencia, 46026
Spain
Helsingborgs Lasarett /ID# 262513
Helsingborg, Skåne County 251 87
Sweden
Uddevalla sjukhus /ID# 262034
Uddevalla, Västra Götaland County 451 80
Sweden
Falu Lasarett /ID# 262231
Falun, 791 82
Sweden
China Medical University Hospital /ID# 245483
Taichung, 40447
Taiwan
Taichung Veterans General Hospital /ID# 261142
Taichung, 40705
Taiwan
National Taiwan University Hospital /ID# 245482
Taipei, 100
Taiwan
Istanbul Florence Nightingale Hospital /ID# 271543
Şişli, Istanbul 34381
Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672
Ankara, 06200
Turkey (Türkiye)
Antalya Egitim Ve Arastirma Hastanesi /ID# 261674
Antalya, 07100
Turkey (Türkiye)
Trakya University Medical Facu /ID# 261673
Edirne, Istanbul, 22030
Turkey (Türkiye)
Addenbrookes Hospital /ID# 261104
Cambridge, Cambridgeshire CB2 2QQ
United Kingdom
Western General Hospital - NHS Lothian /ID# 261106
Edinburgh, Edinburgh, City of EH4 2XU
United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488
London, Greater London SE1 9RT
United Kingdom
Nottingham City Hospital /ID# 261105
Nottingham, Nottinghamshire NG5 1PB
United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 261101
Leeds, West Yorkshire LS9 7TF
United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 262470
London, SW3 6JJ
United Kingdom
The Christie Hospital /ID# 261102
Manchester, M20 4BX
United Kingdom