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NCT06158841PHASE3Recruiting

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

AbbVie

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

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. * 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). \-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 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 (per Investigator's judgment) drug or alcohol abuse within the 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 affect the participant's participation in the study. * Central nervous system involvement of MM. * Has received B-cell maturation antigen (BCMA)-targeted therapy.

Interventions

DRUG

Etentamig

DRUG

Carfilzomib

DRUG

Pomalidomide

DRUG

Elotuzumab

DRUG

Selinexor

DRUG

Bortezomib

DRUG

Dexamethasone

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Conditions

Multiple Myeloma

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