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New hope for blood cancer: Triple-Drug attack shows promise

NCT ID NCT05455320

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study tests whether adding the experimental drug talquetamab to standard treatments (daratumumab and pomalidomide) helps people with multiple myeloma that has returned or stopped responding to prior therapy. About 864 adults will receive either the new combination or the usual care. The main goal is to see if the new combinations delay cancer growth or 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

864 people

The number who actually took part.

Started

Oct 2022

Expected to finish

May 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: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level \>= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain \>= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio * Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (\>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (\<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment * Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received \>=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed * Documented evidence of progressive disease based on investigator's determination of response by the 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 immediately prior to the start of administration of study treatment Exclusion Criteria: * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients * Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody) * Received prior pomalidomide therapy * A maximum cumulative dose of corticosteroids to \>=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug * Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required * Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

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

Multiple myeloma Relapsed or refractory multiple myeloma

Contacts and locations

Locations

  • A.O. Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126, Italy

  • A.O.U. Città della Salute e della Scienza

    Torino, 10126, Italy

  • APHP - Hopital Henri Mondor

    Créteil, 94010, France

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Albert Schweitzer ziekenhuis-lokatie Dordwijk

    Dordrecht, 3318 AT, Netherlands

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28, Greece

  • Ankara University Medical Faculty

    Ankara, 06590, Turkey (Türkiye)

  • Antalya Egitim ve Arastirma Hastanesi

    Antalya, 07100, Turkey (Türkiye)

  • Anticancer Hospital of Thessaloniki Theageneio

    Thessaloniki, 546 39, Greece

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128, Italy

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Beijing Chaoyang Hospital

    Chaoyang District, 100020, China

  • Beilinson medical center

    Petah Tikva, 49100, Israel

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR, United Kingdom

  • Bnai Zion Medical Center

    Haifa, 31048, Israel

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • CHC MontLegia

    Liège, 4000, Belgium

  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie

    Pessac, 33604, France

  • CHU Dijon

    Dijon, 21000, France

  • CHU HOPITAL DE L'ARCHET - Hematology

    Nice, 06202, France

  • CHU Hopital Saint Antoine

    Paris, 75571, France

  • CHU de Montpellier - Hopital Saint-Eloi

    Montpellier, 34295, France

  • CHU de Nantes hotel Dieu

    Nantes, 44093, France

  • Carmel Medical Center

    Haifa, 34362, Israel

  • Centre Leon Berard

    Lyon, 69008, France

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20090, Poland

  • Cerrahpasa Tip Fakultesi Prof. Dr. Murat Dilmener Hastanesi

    Istanbul, 34153, Turkey (Türkiye)

  • Charite Campus Benjamin Franklin

    Berlin, 12203, Germany

  • Chiba Cancer Center

    Chiba, 260-8717, Japan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Clinica Medica Sao Germano LTDA

    São Paulo, 04537 081, Brazil

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Clinique Saint Pierre

    Ottignies, 1340, Belgium

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555, Japan

  • Dokuz Eylul University Medical Faculty

    Izmir, 35330, Turkey (Türkiye)

  • Dong-A University Hospital

    Busan, 602 812, South Korea

  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit

    Ankara, 06200, Turkey (Türkiye)

  • Erasmus MC

    Rotterdam, 3015, Netherlands

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52, Czechia

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • First Affiliated Hospital SooChow University

    Suzhou, 215006, China

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Fukuoka University Hospital

    Fukuoka, 814-0180, Japan

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • Fundacao Pio XII

    Barretos, 14784 400, Brazil

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul, 95070 560, Brazil

  • G Papanikolaou Hospital of Thessaloniki

    Thessalonikis, 570 10, Greece

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Galilee Medical Center

    Nahariya, 22100, Israel

  • George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina

    Florianópolis, 88020 210, Brazil

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • Gunma University Hospital

    Gunma, 371-0034, Japan

  • Ha'Emek Medical Center

    Afula, 1834111, Israel

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hillel Yaffe Medical Center

    Hadera, 3810101, Israel

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Dr. Peset

    Valencia, 46017, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Univ. Virgen de La Arrixaca

    El Palmar, 30120, Spain

  • Hosp. Univ. de Canarias

    San Cristóbal de La Laguna, 38320, Spain

  • Hosp. Univ. de La Princesa

    Madrid, 28006, Spain

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Hosp. de Leon

    León, 24071, Spain

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060, Brazil

  • Hospital Paulistano

    São Paulo, 01323-000, Brazil

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14051140, Brazil

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501, Japan

  • IDOR - Regional Bahia

    Salvador, 41253-190, Brazil

  • IDOR - Regional Brasilia

    Brasília, 70390-140, Brazil

  • IDOR - Regional Sao Paulo

    São Paulo, 01401 002, Brazil

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013, Italy

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

    Tianjin, 300320, China

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519, Japan

  • 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

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695, Japan

  • Japanese Red Cross Society Himeji Hospital

    Hyōgo, 670-8540, Japan

  • Jeonbuk National University Hospital

    Jeonju, 54907, South Korea

  • Joe Arrington Cancer Research Treatment Center

    Lubbock, Texas, 79410, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Kansai Medical University Hospital

    Hirakata, 573 1191, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kyoto Kuramaguchi Medical Center

    Kyoto, 603-8151, Japan

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204, United States

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062-000, Brazil

  • Liv Hospital Ankara

    Ankara, 06680, Turkey (Türkiye)

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General

    Boston, Massachusetts, 02114, United States

  • Maxima Medisch Centrum

    Eindhoven, 5631 BM, Netherlands

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-8900, United States

  • Medipol Mega University Hospital

    Istanbul, 34214, Turkey (Türkiye)

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • 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 Taiwan University Hospital

    Taipei, 10048, Taiwan

  • New Cross Hospital

    Wolverhampton, WV10 0QP, United Kingdom

  • Newcastle Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY, United Kingdom

  • Norwalk Hospital-oncology

    Norwalk, Connecticut, 06850, United States

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Novant Health

    Winston-Salem, North Carolina, 27103, United States

  • Novant Health 1

    Charlotte, North Carolina, 28204, United States

  • Ochsner Health System

    New Orleans, Louisiana, 70121-2429, United States

  • Ogaki Municipal Hospital

    Gifu, 503-8502, Japan

  • OhioHealth

    Columbus, Ohio, 43214, United States

  • Ondokuz Mayis University

    Samsun, 55139, Turkey (Türkiye)

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146, Italy

  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

    Catania, 95123, Italy

  • Peking Union Medical College Hospital

    Beijing, 100006, China

  • Peking University First Hospital

    Beijing, 100034, China

  • Peking University Shenzhen Hospital

    Shenzhen, 518036, China

  • Policlinico di Bari

    Bari, 70124, Italy

  • Pratia Onkologia Katowice

    Katowice, 40 519, Poland

  • Presidio Ospedaliero Santo Spirito in Sassia

    Roma, 00193, Italy

  • Rambam Medical Center

    Haifa, 31096, Israel

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01321-001, Brazil

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221, Brazil

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300, Israel

  • Shanghai Fourth People s Hospital

    Shanghai, 200434, China

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Shonan Kamakura General Hospital

    Kamakura-shi, 247-8533, Japan

  • Sichuan Academy of Medical Science Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901, Brazil

  • Sourasky (Ichilov) Medical Center

    Tel Aviv, 6423906, Israel

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510710, China

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734, Poland

  • Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii

    Olsztyn, 10-228, Poland

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozów, 36-200, Poland

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30 688, Poland

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550, Japan

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Ohio State University Wexner Medical Center - James Cancer Hospital

    Columbus, Ohio, 43210, United States

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719, United States

  • The University of Osaka Hospital

    Suita, 565 0871, Japan

  • The second Xiangya Hospital of Central South University

    Changsha, 410000, China

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107-4215, United States

  • Tianjin cancer hospital

    Tianjin, 300060, China

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • Tongji Hospital of Tongji University

    Shanghai, 200065, China

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030, China

  • Tulane University Hospital & Clinics

    New Orleans, Louisiana, 70112, United States

  • UCL Mont Godinne

    Yvoir, 5530, Belgium

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZA

    Edegem, 2650, Belgium

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH, United Kingdom

  • University Of Illinois

    Chicago, Illinois, 60612, United States

  • University Of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Kansas

    Westwood, Kansas, 66205, United States

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

  • University of Miami Health System

    Miami, Florida, 33136, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Universitätsmedizin der Johannes Gutenberg Universität

    Mainz, 55131, Germany

  • Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie

    Szczecin, 71-252, Poland

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • Virga Jessa Ziekenhuis

    Hasselt, 3500, Belgium

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

    Prague, 128 08, Czechia

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School Of Medicine

    St Louis, Missouri, 63110-1032, United States

  • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

    Torun, 87 100, Poland

  • Ziv Medical Center

    Safed, 13100, Israel

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