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New hope for Tough-to-Treat blood cancer: phase 3 trial launches

NCT ID NCT06158841

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 10 times

Summary

This study tests a new drug called etentamig against standard treatments for adults with multiple myeloma that has returned or stopped responding. About 380 participants will receive either etentamig or a standard therapy chosen by their doctor. The goal is to see if etentamig can delay cancer growth and improve response rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

421 people

The number who actually took part.

Started

May 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808

    Turin, Piedmont, 10126, Italy

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

    Catania, 95123, Italy

  • ASST Ovest Milanese /ID# 256813

    Legnano, Milano, 20025, Italy

  • Addenbrookes Hospital /ID# 261104

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Alberts Cellular Therapy /ID# 245725

    Pretoria, Gauteng, 0044, South Africa

  • Alexandra General Hospital /ID# 240591

    Athens, Attica, 11528, Greece

  • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 245345

    Bruges, West-Vlaanderen, 8000, Belgium

  • Algemeen Ziekenhuis klina /ID# 260856

    Brasschaat, Antwerpen, 2930, Belgium

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

    Berkeley, California, 94705, United States

  • Anjo Kosei Hospital /ID# 263434

    Anjo, Aichi-ken, 446-8602, Japan

  • Antalya Egitim Ve Arastirma Hastanesi /ID# 261674

    Antalya, 07100, Turkey (Türkiye)

  • Atrium Health Levine Cancer Institute /ID# 246199

    Charlotte, North Carolina, 28204, United States

  • Auxilio Mutuo Cancer Center /ID# 272565

    San Juan, 00918, Puerto Rico

  • Azienda Ospedaliero Universitaria delle Marche /ID# 256812

    Ancona, 60126, Italy

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

    Rome, Roma, 00161, Italy

  • Baptist Memorial Hospital /ID# 270910

    Memphis, Tennessee, 38120, United States

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

    Lansing, Michigan, 48912, United States

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

    Beijing, Beijing Municipality, 100020, China

  • Beth Israel Deaconess Medical Center /ID# 271535

    Boston, Massachusetts, 02215, United States

  • Box Hill Hospital /ID# 262784

    Melbourne, Victoria, 3128, Australia

  • CH Henri Duffaut /ID# 261844

    Avignon, Vaucluse, 84902, France

  • CH Saint-Quentin /ID# 261856

    Saint-Quentin, Aisne, 02321, France

  • Calvary Mater Newcastle /ID# 261804

    Waratah, New South Wales, 2298, Australia

  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230

    Jacksonville, Florida, 32256, United States

  • Cedars-Sinai Medical Center /ID# 261008

    Los Angeles, California, 90048, United States

  • Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637

    Bethesda, Maryland, 20817, United States

  • Centre Hospitalier Regional d Orleans - Hopital de la Source /ID# 261854

    Orléans, Loiret, 45067, France

  • Centre Hospitalier du Mans /ID# 261852

    Le Mans, Sarthe, 72037, France

  • Centrum fuer Haematologie und Onkologie Bethanien /ID# 271982

    Frankfurt am Main, 60389, Germany

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

    Berlin, 12203, Germany

  • Chiba University Hospital /ID# 262006

    Chiba, Chiba, 260-8677, Japan

  • China Medical University Hospital /ID# 245483

    Taichung, 40447, Taiwan

  • Chugoku Central Hospital /ID# 263431

    Fukuyama, Hiroshima, 720-0001, Japan

  • Cleveland Clinic Main Campus /ID# 246183

    Cleveland, Ohio, 44195, United States

  • Complejo Hospitalario Universitario Ourense /ID# 246400

    Ourense, Ourense, 32005, Spain

  • Constantiaberg Haematology /ID# 261320

    Cape Town, Western Cape, 7800, South Africa

  • Dana-Farber Cancer Institute /ID# 261554

    Boston, Massachusetts, 02215, United States

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

    Ankara, 06200, Turkey (Türkiye)

  • Duke University Medical Center /ID# 259694

    Durham, North Carolina, 27710, United States

  • Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488

    London, Greater London, SE1 9RT, United Kingdom

  • Eastchester Center for Cancer Care /ID# 262952

    The Bronx, New York, 10469, United States

  • Fakultni Nemocnice Brno - Jihlavska /ID# 245689

    Brno, Brno-mesto, 625 00, Czechia

  • Fakultni Nemocnice Ostrava /ID# 245686

    Ostrava, Ostrava-mesto, 708 52, Czechia

  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 245690

    Hradec Králové, 500 05, Czechia

  • Falu Lasarett /ID# 262231

    Falun, 791 82, Sweden

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

    Shenyang, Liaoning, 110001, China

  • Fujian Medical University Union Hospital /ID# 245558

    Fuzhou, Fujian, 350001, China

  • Fundacao Champalimaud /ID# 246258

    Lisbon, Lisbon District, 1400-038, Portugal

  • 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

  • Gifu Municipal Hospital /ID# 263321

    Gifu, Gifu, 500-8323, Japan

  • Gunma University Hospital /ID# 262580

    Maebashi, Gunma, 371-8511, Japan

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

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Haemalife Inc. /ID# 245724

    Kuils River, Western Cape, 7580, South Africa

  • Helsingborgs Lasarett /ID# 262513

    Helsingborg, Skåne County, 251 87, Sweden

  • Hematology And Oncology Institute /ID# 272531

    Manati, 00674, Puerto Rico

  • Henan Cancer Hospital /ID# 245536

    Zhengzhou, Henan, 450008, China

  • Henry Ford Hospital /ID# 262704

    Detroit, Michigan, 48202, United States

  • 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

  • Hospital de Leon /ID# 261624

    León, 24071, Spain

  • Hyogo Prefectural Amagasaki General Medical Center /ID# 265696

    Amagasaki, Hyōgo, 660-8550, Japan

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

    Tianjin, Tianjin Municipality, 300020, China

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

    Badalona, Barcelona, 08916, Spain

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

    Porto, 4200-072, Portugal

  • Istanbul Florence Nightingale Hospital /ID# 271543

    Şişli, Istanbul, 34381, Turkey (Türkiye)

  • Japanese Red Cross Medical Center /ID# 261717

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Karmanos Cancer Institute - Detroit /ID# 266298

    Detroit, Michigan, 48201, United States

  • Klinik Ottakring /ID# 245829

    Vienna, State of Vienna, 1160, Austria

  • Klinikum Chemnitz - Flemmingstrabe /ID# 273108

    Chemnitz, Saxony, 09116, Germany

  • Kyushu University Hospital /ID# 264704

    Fukuoka, Fukuoka, 812-8582, Japan

  • Leeds Teaching Hospitals NHS Trust /ID# 261101

    Leeds, West Yorkshire, LS9 7TF, United Kingdom

  • Liverpool Hospital /ID# 262159

    Liverpool, New South Wales, 2170, Australia

  • Mayo Clinic - Rochester /ID# 246228

    Rochester, Minnesota, 55905-0001, United States

  • Mayo Clinic Hospital - Phoenix /ID# 263326

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Hospital Jacksonville /ID# 263324

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina /ID# 259692

    Charleston, South Carolina, 29425, United States

  • Medizinische Universitaet Graz /ID# 261908

    Graz, Styria, 8010, Austria

  • Miyagi Cancer Center /ID# 265094

    Natori-shi, Miyagi, 981-1293, Japan

  • Monash Health - Monash Medical Centre - Clayton /ID# 262158

    Clayton, Victoria, 3168, Australia

  • Nagoya City University Hospital /ID# 263320

    Nagoya, Aichi-ken, 467-8602, Japan

  • Naha City Hospital /ID# 263972

    Naha, Okinawa, 902-0061, Japan

  • Nancy W. Knowles Cancer Center /ID# 271361

    Elmhurst, Illinois, 60126, United States

  • National Taiwan University Hospital /ID# 245482

    Taipei, 100, Taiwan

  • 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

  • Northwest Medical Specialties Tacoma /ID# 276281

    Tacoma, Washington, 98405, United States

  • Nottingham City Hospital /ID# 261105

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Odense University Hospital /ID# 260924

    Odense, Region Syddanmark, 5000, Denmark

  • Oncology Consultants /ID# 276774

    Houston, Texas, 77030, United States

  • Ordensklinikum Linz Elisabethinen /ID# 245609

    Linz, Upper Austria, 4010, Austria

  • Oregon Medical Research Center /ID# 262335

    Portland, Oregon, 97239, United States

  • Our Lady Of The Lake Regional Medical Center /ID# 272780

    Baton Rouge, Louisiana, 70808, United States

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

    Beijing, Beijing Municipality, 100730, China

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

    Zhengzhou, Henan, 450003, China

  • Princess Alexandra Hospital - Woolloongabba /ID# 261810

    Woolloongabba, Queensland, 4102, Australia

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

    Fullerton, California, 92835, United States

  • Rabin Medical Center. /ID# 245498

    Petah Tikva, Central District, 4941492, Israel

  • Regents of the University of Michigan /ID# 261577

    Ann Arbor, Michigan, 48109-1276, United States

  • Rocky Mountain Cancer Centers - Lone Tree /ID# 278320

    Lone Tree, Colorado, 80124, United States

  • Rush University Medical Center /ID# 265690

    Chicago, Illinois, 60612, United States

  • Saitama Prefectural Cancer Center /ID# 262586

    Kitaadachi-gun, Saitama, 362-0806, Japan

  • Samsung Medical Center /ID# 245492

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Second Affiliated Hospital of Xian Jiaotong University /ID# 261255

    Xi'an, Shaanxi, 710004, China

  • Semmelweis Egyetem /ID# 261646

    Budapest, 1085, Hungary

  • Semmelweis Egyetem /ID# 261647

    Budapest, 1085, Hungary

  • Seoul National University Hospital /ID# 245491

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shaare Zedek Medical Center /ID# 245681

    Jerusalem, Jerusalem, 91031, Israel

  • Shanghai Tongji Hospital /ID# 245539

    Shanghai, Shanghai Municipality, 200065, China

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

    Hangzhou, Zhejiang, 310020, China

  • Springfield Clinic - First /ID# 262266

    Springfield, Illinois, 62702, United States

  • St George Hospital - Kogarah /ID# 261806

    Kogarah, New South Wales, 2217, Australia

  • St Vincent's Hospital Melbourne /ID# 261808

    Fitzroy Melbourne, Victoria, 3065, Australia

  • Staedtisches Klinikum Karlsruhe /ID# 272377

    Karlsruhe, Baden-Wurttemberg, 76133, Germany

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

    Guangzhou, Guangdong, 510060, China

  • Taichung Veterans General Hospital /ID# 261142

    Taichung, 40705, Taiwan

  • Tel Aviv Sourasky Medical Center /ID# 245495

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Texas Oncology - Northeast Texas /ID# 278304

    Tyler, Texas, 75702, United States

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

    Seoul, Seoul Teugbyeolsi, 06591, South Korea

  • The Chaim Sheba Medical Center /ID# 245497

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Christie Hospital /ID# 261102

    Manchester, M20 4BX, United Kingdom

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

    Nanchang, Jiangxi, 330006, China

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

    Suzhou, Jiangsu, 215006, China

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

    Wenzhou, Zhejiang, 325000, China

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

    Hangzhou, Zhejiang, 310003, China

  • The Royal Marsden NHS Foundation Trust /ID# 262470

    London, SW3 6JJ, United Kingdom

  • The University of Osaka Hospital /ID# 263974

    Suita-shi, Osaka, 565-0871, Japan

  • The West Clinic /ID# 262444

    Memphis, Tennessee, 38120, United States

  • Tianjin Medical University General Hospital /ID# 260851

    Tianjin, Tianjin Municipality, 300052, China

  • Tokyo Metropolitan Komagome Hospital /ID# 277567

    Bunkyo Ku, Tokyo, 113-8677, Japan

  • Trakya University Medical Facu /ID# 261673

    Edirne, Istanbul, 22030, Turkey (Türkiye)

  • Uddevalla sjukhus /ID# 262034

    Uddevalla, Västra Götaland County, 451 80, Sweden

  • Ulsan University Hospital /ID# 245490

    Ulsan, Ulsan Gwang Yeogsi, 44033, South Korea

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

    Lisbon, 1649-035, Portugal

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

    Wuhan, Hubei, 430022, China

  • Universitaetsklinikum Freiburg /ID# 262147

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 260651

    Hamburg, 20246, Germany

  • Universitaetsklinikum Krems /ID# 261509

    Krems, Lower Austria, 3500, Austria

  • University General Hospital Attikon /ID# 240592

    Chaïdári, Attica, 12462, Greece

  • University Health Network_Princess Margaret Cancer Centre /ID# 261566

    Toronto, Ontario, M5G 2M9, Canada

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

    Kyoto, Kyoto, 602-8566, Japan

  • University Of Cincinnati Medical Center /ID# 246415

    Cincinnati, Ohio, 45219, United States

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

    Birmingham, Alabama, 35233, United States

  • University of Fukui Hospital /ID# 264222

    Yoshida-gun, Fukui, 910-1104, Japan

  • University of Illinois Hospital and Health Sciences System /ID# 246349

    Chicago, Illinois, 60607, United States

  • University of Missouri Hospital /ID# 261553

    Columbia, Missouri, 65212, United States

  • University of North Carolina /ID# 259854

    Chapel Hill, North Carolina, 27514, United States

  • University of Tennessee Health Science Center /ID# 261622

    Memphis, Tennessee, 38103, United States

  • University of Yamanashi Hospital /ID# 262912

    Chuo-shi, Yamanashi, 409-3898, Japan

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

    Lublin, Lublin Voivodeship, 20-081, Poland

  • Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 260172

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

  • Uniwersyteckie Centrum Kliniczne /ID# 260169

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • VA Loma Linda Healthcare System /ID# 261015

    Loma Linda, California, 92357, United States

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

    Richmond, Virginia, 23298, United States

  • Vanderbilt University Medical Center /ID# 261621

    Nashville, Tennessee, 37232-0011, United States

  • Vejle Sygehus /ID# 260923

    Vejle, Region Syddanmark, 7100, Denmark

  • Virginia Cancer Specialists - Fairfax /ID# 262792

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314

    Norfolk, Virginia, 23502, United States

  • Vseobecna Fakultni nemocnice v Praze /ID# 245691

    Prague, Praha 17, 128 00, Czechia

  • Western General Hospital /ID# 261106

    Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

  • Winship Cancer Institute of Emory University /ID# 262525

    Atlanta, Georgia, 30322, United States

  • Yonsei University Health System Severance Hospital /ID# 245489

    Seoul, 03722, South Korea

  • Zhongda Hospital Southeast University /ID# 245563

    Nanjing, Jiangsu, 210009, China

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