Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo aims to stall return of blood cancer

NCT ID NCT05083169

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 times

Summary

This study tests whether a new two-drug combination (teclistamab plus daratumumab) works better than standard three-drug combos for people whose multiple myeloma has returned or stopped responding to treatment. About 587 adults with measurable disease will be randomly assigned to one of the treatments. The main goal is to see how long the cancer stays under control.

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

587 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Sep 2028

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: * Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion * Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen * Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment * Have clinical laboratory values within the specified range Exclusion Criteria: * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include: 1. A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG, 2. A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade \>= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization * Received any prior B cell maturation antigen (BCMA)-directed therapy * Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days before randomization * Received a live, attenuated vaccine within 4 weeks before randomization * Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

    Turin, 10126, Italy

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127, Italy

  • AZ St.-Jan Brugge-Oostende AV

    Bruges, 8000, Belgium

  • Aalborg University Hospital

    Aalborg, DK-9000, Denmark

  • Aarhus University Hospital

    Aarhus N, DK-8200, Denmark

  • Akademiska Sjukhuset

    Uppsala, 75185, Sweden

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28, Greece

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800, Belgium

  • Ankara University Medical Faculty

    Ankara, 06590, Turkey (Türkiye)

  • Anticancer Hospital of Thessaloniki Theageneio

    Thessaloniki, 546 39, Greece

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Az Groeninge

    Kortrijk, 8500, Belgium

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • BC Cancer Agency - Vancouver BC

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Beijing Chaoyang Hospital

    Chaoyang District, 100020, China

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool, FY3 8NR, United Kingdom

  • C.H.U. Hotel Dieu - France

    Nantes, 44093, France

  • CHRU Hôpital Bretonneau

    Tours, 37044, France

  • CHU De Poitiers

    Poitiers, 86021, France

  • CHU Henri Mondor

    Créteil, 94000, France

  • CHU de Limoges Hopital Dupuytren

    Limoges, 87042, France

  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

    Florianópolis, 88034-000, Brazil

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090, Poland

  • Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Medica Sao Germano LTDA

    São Paulo, 04537 081, Brazil

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024, Russia

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555, Japan

  • Dokuz Eylul University Medical Faculty

    Izmir, 35340, Turkey (Türkiye)

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Evang. Krankenhaus Essen-Mitte gGmbH

    Essen, 45239, Germany

  • Falu Lasarett

    Falun, 791 82, Sweden

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021, China

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • First affiliated Hospital of Zhejiang University 1

    Hangzhou, 310003, China

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Fujian Meidical University Union Hospital

    Fuzhou, 350001, China

  • Fukuoka University Hospital

    Fukuoka, 814-0180, Japan

  • G.Papanikolaou

    Thessaloniki, 57010, Greece

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Heinrich-Heine -Universitaet Duesseldorf

    Düsseldorf, 40225, Germany

  • Helsingborgs lasarett

    Helsingborg, 25187, Sweden

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Henry Ford Health System

    Southfield, Michigan, 48075, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hopital Claude Huriez

    Lille, 59000, France

  • Hopital de Jolimont

    Haine Saint Paul La Louviere, 7100, Belgium

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 8035, Spain

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Univ. Son Espases

    Palma, 7120, Spain

  • Hosp. Univ. de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35010, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hosp. de Cabuenes

    Gijón, 33394, Spain

  • Hospices Civils de Lyon HCL

    Lyon, 69002, France

  • Hospitais Integradaos da Gavea S/A - DF Star

    Brasília, 70390-140, Brazil

  • Hospital Aleman

    CABA, C1118AAT, Argentina

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060, Brazil

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB, Argentina

  • Hospital Paulistano

    São Paulo, 01323-000, Brazil

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH, Argentina

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501, Japan

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200, France

  • IDOR - Regional Bahia

    Salvador, 41253-190, Brazil

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100, Italy

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908, Spain

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo, 4501000, Brazil

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001, Brazil

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170, Brazil

  • Isala Kliniek

    Zwolle, 8025 AB, Netherlands

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014, Italy

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695, Japan

  • Japanese Red Cross Medical Center

    Shibuya-ku, 150-8935, Japan

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klinika Hematologii i Transplantologii, UCK

    Gdansk, 80-214, Poland

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000, Brazil

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-8900, United States

  • Medipol University Hospital

    Istanbul, 34214, Turkey (Türkiye)

  • Nagoya City University Hospital

    Nagoya, 467 8602, Japan

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • National Cancer Center Hospital East

    Kashiwa, 277 8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Ōtake, 739-0696, Japan

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701, Japan

  • National Hospital Organization Mito Medical Center

    Higashiibaraki-gun, 311-3193, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520, Japan

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY, United Kingdom

  • Norrlands Universitetssjukhus

    Umeå, 901 85, Sweden

  • Odense Universitets Hospital

    Odense, 5000, Denmark

  • Ogaki Municipal Hospital

    Gifu, 503-8502, Japan

  • Ondokuz Mayis University

    Atakum, 55280, Turkey (Türkiye)

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • Peking University First Hospital

    Beijing, 100034, China

  • Peking University People's Hospital

    Beijing, 100044, China

  • Peking University Shenzhen Hospital

    Shenzhen, 518036, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138, Italy

  • Pratia Onkologia Katowice

    Katowice, 40 519, Poland

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1X6, Canada

  • Pôle IUC Oncopole CHU

    Toulouse, 31059, France

  • QEII Health Sciences

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Radboudumc

    Nijmegen, 6525GA, Netherlands

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 900, Brazil

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284, Russia

  • S.P. Botkin Moscow City Clinical Hospital 1

    Moscow, 125284, Russia

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai Zhongshan Hospital

    Shanghai, 200032, China

  • Shengjing Hospital Of China Medical University

    Shenyang, 110136, China

  • Shonan Kamakura General Hospital

    Kamakura-shi, 247-8533, Japan

  • Sint Antonius Ziekenhuis - Afd.Interne - INT

    Nieuwegein, 3435 CM, Netherlands

  • Skanes universitetssjukhus

    Lund, 221 85, Sweden

  • Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu

    Wałbrzych, 58 309, Poland

  • St. Barbara-Klinik Hamm GmbH

    Hamm, 59073, Germany

  • Stanford University Medical Center

    Stanford, California, 94305-5623, United States

  • Sun Yat -Sen University Cancer Center

    Guangzhou, 511363, China

  • Sunderby Sjukhus

    Luleå, 971 80, Sweden

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734, Poland

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221000, China

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004, China

  • The Third Xiangya Hospital of Central Sourth University

    Changshashi, 410013, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060, China

  • Tianjin Medical University General Hospital

    Tianjin, 300011, China

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • Tokai University Hospital

    Isehara, 259-1193, Japan

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • U.O. Ematologia con Trapianto- AOU Policlinico di Bari

    Bari, 70124, Italy

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitaetsklinikum Carl-Gustav-Carus Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH, United Kingdom

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Università di Roma 'La Sapienza' - Ospedale Umberto 1°

    Roma, 00161, Italy

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367, Poland

  • VU Medisch Centrum

    Amsterdam, 1081 HV, Netherlands

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Vejle Hospital

    Vejle, DK-7100, Denmark

  • West China Hospital Sichuan University

    Chengdu, 610041, China

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

  • ZAS Cadix

    Antwerp, 2030, Belgium

  • Zhongda Hospital Southeast University

    Nanjing, 210009, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.