Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

Last updated: March 25, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Red Blood Cell Disorders

Platelet Disorders

Lymphoproliferative Disorders

Treatment

Selinexor

ABBV-383

Dexamethasone

Clinical Study ID

NCT06158841
M22-574
2023-506668-15-00
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2.

  • Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after theparticipant's last treatment as stated in the protocol.

  • Must have measurable disease with at least 1 of the following assessed within 28days 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 lightchain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serumkappa lambda ratio.

  • Must have received at least 2 or more lines of therapy, including a proteasomeinhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonalantibody (mAb).

  • Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, andinstitutional guidelines.

Exclusion

Exclusion Criteria:

  • Clinically significant (per Investigator's judgment) drug or alcohol abuse withinthe last 6 months.

  • 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 affectthe participant's participation in the study.

  • Central nervous system involvement of MM.

  • Has received B-cell maturation antigen (BCMA)-targeted therapy.

Study Design

Total Participants: 380
Treatment Group(s): 8
Primary Treatment: Selinexor
Phase: 3
Study Start date:
May 19, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • St George Hospital /ID# 261806

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Liverpool Hospital /ID# 262159

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle /ID# 261804

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital /ID# 261810

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 262158

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 262158

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne /ID# 261808

    Fitzroy Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • Box Hill Hospital /ID# 262784

    Melbourne, Victoria 3128
    Australia

    Active - Recruiting

  • Universitaetsklinikum Krems /ID# 261509

    Krems an der Donau, Niederoesterreich 3500
    Austria

    Active - Recruiting

  • Ordensklinikum Linz GmbH Elisabethinen /ID# 245609

    Linz, Oberoesterreich 4010
    Austria

    Active - Recruiting

  • Medizinische Universitaet Graz /ID# 261908

    Graz, Steiermark 8010
    Austria

    Active - Recruiting

  • Klinik Ottakring /ID# 245829

    Vienna, Wien 1160
    Austria

    Active - Recruiting

  • Algemeen Ziekenhuis klina /ID# 260856

    Brasschaat, Antwerpen 2930
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge /ID# 245345

    Brugge, 8000
    Belgium

    Active - Recruiting

  • Beijing Chaoyang Hospital,Capital Medical University /ID# 245533

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 245545

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital /ID# 245558

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center /ID# 245542

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Henan Cancer Hospital /ID# 245536

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • People's Hospital of Henan Province /ID# 260918

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Zhongda Hospital Southeast University /ID# 245563

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University /ID# 245544

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University /ID# 245537

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Hospital of China Medical University /ID# 245547

    Shenyang, Liaoning 110001
    China

    Active - Recruiting

  • Shanghai Tongji Hospital /ID# 245539

    Shanghai, Shanghai 200065
    China

    Active - Recruiting

  • Institute of Hematology and Blood Diseases Hospital /ID# 265702

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital /ID# 260851

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882

    Hangzhou, Zhejiang 310020
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 245550

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • Fakultní Nemocnice Brno - Jihlavská /ID# 245689

    Brno, Brno-mesto 625 00
    Czechia

    Active - Recruiting

  • Fakultní nemocnice Hradec Králové - Sokolská /ID# 245690

    Hradec Králové, Hradec Kralove 500 05
    Czechia

    Active - Recruiting

  • Fakultni Nemocnice Ostrava /ID# 245686

    Ostrava, Ostrava-mesto 708 52
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze /ID# 245691

    Praha, 128 08
    Czechia

    Active - Recruiting

  • Odense University Hospital /ID# 260924

    Odense, Syddanmark 5000
    Denmark

    Active - Recruiting

  • Sygehus Lillebalt, Vejle /ID# 260923

    Vejle, Syddanmark 7100
    Denmark

    Active - Recruiting

  • Ch Saint Quentin /Id# 261856

    St Quentin CEDEX, Aisne 02321
    France

    Active - Recruiting

  • Centre Hospitalier du Mans /ID# 261852

    Le Mans CEDEX 9, Sarthe 72037
    France

    Active - Recruiting

  • CH Henri Duffaut /ID# 261844

    Avignon CEDEX 9, Vaucluse 84902
    France

    Active - Recruiting

  • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854

    Orléans, 45067
    France

    Active - Recruiting

  • Universitaetsklinikum Freiburg /ID# 262147

    Freiburg, Baden-Wuerttemberg 79106
    Germany

    Active - Recruiting

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689

    Berlin, 12203
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 260651

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Alexandra General Hospital /ID# 240591

    Athens, Attiki 11528
    Greece

    Active - Recruiting

  • University General Hospital Attikon /ID# 240592

    Athens, Attiki 12462
    Greece

    Active - Recruiting

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596

    Athens, 10676
    Greece

    Active - Recruiting

  • General University Hospital of Thessaloniki AXEPA /ID# 240595

    Thessaloniki, 54636
    Greece

    Active - Recruiting

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648

    Gyor, Gyor-Moson-Sopron 9024
    Hungary

    Active - Recruiting

  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 261646

    Budapest, 1097
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem /ID# 261647

    Budapest, 1085
    Hungary

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 245497

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 245495

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center /ID# 245681

    Jerusalem, Yerushalayim 91031
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 245498

    Haifa, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 245498

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • ASST Ovest Milanese /ID# 256813

    Legnano, Milano 20025
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810

    Rome, Roma 00161
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria delle Marche /ID# 256812

    Ancona, 60020
    Italy

    Active - Recruiting

  • AOU Policlinico G. Rodolico - San Marco /ID# 256814

    Catania, 95123
    Italy

    Active - Recruiting

  • Anjo Kosei Hospital /ID# 263434

    Anjo, Aichi 446-8602
    Japan

    Active - Recruiting

  • Nagoya City University Hospital /ID# 263320

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Chiba University Hospital /ID# 262006

    Chiba-shi, Chiba 260-8677
    Japan

    Active - Recruiting

  • University of Fukui Hospital /ID# 264222

    Yoshida-gun, Fukui 910-1104
    Japan

    Active - Recruiting

  • Kyushu University Hospital /ID# 264704

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Gifu Municipal Hospital /ID# 263321

    Gifu-shi, Gifu 500-8323
    Japan

    Active - Recruiting

  • Gunma University Hospital /ID# 262580

    Maebashi-shi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Chugoku Central Hospital /ID# 263431

    Fukuyama, Hiroshima 720-0001
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine /ID# 262585

    Kyoto-shi, Kyoto 602-8566
    Japan

    Active - Recruiting

  • Miyagi Cancer Center /ID# 265094

    Natori, Miyagi 981-1293
    Japan

    Active - Recruiting

  • Naha City Hospital /ID# 263972

    Naha, Okinawa 902-0061
    Japan

    Active - Recruiting

  • Osaka University Hospital /ID# 263974

    Suita City, Osaka 5650871
    Japan

    Site Not Available

  • Osaka University Hospital /ID# 263974

    Suita-shi, Osaka 565-0871
    Japan

    Active - Recruiting

  • The University of Osaka Hospital /ID# 263974

    Suita-shi, Osaka 565-0871
    Japan

    Active - Recruiting

  • Saitama Cancer Center /ID# 262586

    Kitaadachi-gun, Saitama 362-0806
    Japan

    Active - Recruiting

  • Japanese Red Cross Medical Center /ID# 261717

    Shibuya-ku, Tokyo 150-8935
    Japan

    Active - Recruiting

  • Hyogo Prefectural Amagasaki General Medical Center /ID# 265696

    Amagasaki, 660-8550
    Japan

    Active - Recruiting

  • Samsung Medical Center /ID# 245492

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital /ID# 245491

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital /ID# 245490

    Ulsan, Ulsan Gwang Yeogsi 44033
    Korea, Republic of

    Active - Recruiting

  • Yonsei University Health System Severance Hospital /ID# 245489

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu /ID# 260172

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168

    Lublin, Lubelskie 20-081
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne /ID# 260169

    Gdansk, Pomorskie 80-214
    Poland

    Active - Recruiting

  • Fundacao Champalimaud /ID# 246258

    Lisbon, Lisboa 1400-038
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Santa Maria, EPE /ID# 246255

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257

    Porto, 4200-072
    Portugal

    Active - Recruiting

  • Alberts Cellular Therapy /ID# 245725

    Pretoria, Gauteng 0044
    South Africa

    Active - Recruiting

  • Constantiaberg Haematology /ID# 261320

    Cape Town, Western Cape 7800
    South Africa

    Active - Recruiting

  • Haemalife Inc. /ID# 245724

    Kuilsrivier, Western Cape 7580
    South Africa

    Active - Recruiting

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario Ourense /ID# 246400

    Orense, Ourense 32005
    Spain

    Active - Recruiting

  • Hospital de Leon /ID# 261624

    Leon, 24071
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon /ID# 246401

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca /ID# 262218

    Salamanca, 37711
    Spain

    Active - Recruiting

  • Hospital Universitario y Politecnico La Fe /ID# 261625

    Valencia, 46026
    Spain

    Active - Recruiting

  • Helsingborgs Lasarett /ID# 262513

    Helsingborg, Skane Lan 251 87
    Sweden

    Active - Recruiting

  • Uddevalla sjukhus /ID# 262034

    Uddevalla, Vastra Gotalands Lan 451 80
    Sweden

    Active - Recruiting

  • Falu Lasarett /ID# 262231

    Falun, 791 82
    Sweden

    Active - Recruiting

  • National Taiwan University Hospital /ID# 245482

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • China Medical University Hospital /ID# 245483

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital /ID# 261142

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672

    Ankara, 06200
    Turkey

    Active - Recruiting

  • Antalya Egitim Ve Arastirma Hastanesi /ID# 261674

    Antalya, 07100
    Turkey

    Active - Recruiting

  • Trakya University Medical Facu /ID# 261673

    Edirne, Istanbul, 22030
    Turkey

    Active - Recruiting

  • Istanbul Florence Nightingale Hospital /ID# 271543

    Şişli, 34381
    Turkey

    Active - Recruiting

  • Addenbrooke's Hospital /ID# 261104

    Cambridge, Cambridgeshire CB2 2QQ
    United Kingdom

    Active - Recruiting

  • Guys and St Thomas NHS Foundation Trust /ID# 262488

    London, Greater London SE1 9RT
    United Kingdom

    Active - Recruiting

  • The Christie Hospital /ID# 261102

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham - Main /ID# 261434

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Alta Bates Summit Medical Center for Research /ID# 261438

    Berkeley, California 94705
    United States

    Active - Recruiting

  • Providence - St. Jude Medical Center /ID# 262031

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center /ID# 261008

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Cancer Specialists of North Florida /ID# 246230

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Emory University, Winship Cancer Institute /ID# 262525

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Illinois at Chicago /ID# 246349

    Chicago, Illinois 60607
    United States

    Active - Recruiting

  • Springfield Clinic /ID# 262266

    Springfield, Illinois 62702-3749
    United States

    Active - Recruiting

  • Center for Cancer and Blood Disorders /ID# 263637

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Regents of the University of Michigan /ID# 261577

    Ann Arbor, Michigan 48109-1276
    United States

    Active - Recruiting

  • Henry Ford Hospital /ID# 262704

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Karmanos Cancer Institute - Detroit /ID# 266298

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891

    Lansing, Michigan 48912
    United States

    Active - Recruiting

  • University of Missouri Hospital /ID# 261553

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • New York Cancer & Blood Specialists - Bay Shore /ID# 261524

    Bay Shore, New York 11706
    United States

    Active - Recruiting

  • Eastchester Center for Cancer Care /ID# 262952

    Bronx, New York 10469
    United States

    Active - Recruiting

  • New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953

    New Hyde Park, New York 11042
    United States

    Active - Recruiting

  • New York Cancer and Blood Specialists - New York /ID# 262951

    New York, New York 10028
    United States

    Active - Recruiting

  • University of North Carolina /ID# 259854

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Levine Cancer Institute /ID# 246199

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • University Of Cincinnati Medical Center /ID# 246415

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic Main Campus /ID# 246183

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Medical University of South Carolina /ID# 259692

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Virginia Cancer Specialists - Fairfax /ID# 262792

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944

    Richmond, Virginia 23298
    United States

    Active - Recruiting

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