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

NCT ID NCT07258511

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 6 times

Summary

This study tests a new drug, JNJ-79635322, against another antibody treatment in people with multiple myeloma that has come back or stopped responding after at least three prior treatments. About 400 participants will be randomly assigned to one of the two treatments. The goal is to see which one works better at shrinking tumors and delaying disease progression.

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

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Sep 2031

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: * Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: 1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria 2. Measurable disease at screening as assessed by central laboratory * Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody * Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by IMWG criteria * Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration Exclusion: * Active hepatitis of infectious origin * Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM * Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab * Major surgery, (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, or during study treatment

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    144 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U. SS. Antonio e Biagio e Cesare Arrigo

    RECRUITING

    Alessandria, 15121, Italy

  • APHP

    RECRUITING

    Paris, 75012, France

  • Akershus Universitetssykehus

    RECRUITING

    Lorenskog, 1478, Norway

  • Alexandra General Hospital of Athens

    RECRUITING

    Athens, 11528, Greece

  • Arcispedale Santa Maria Nuova - IRCCS

    RECRUITING

    Reggio Emilia, 42123, Italy

  • Arthur J E Child Comprehensive Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N 4N1, Canada

  • Assuta MC

    RECRUITING

    Tel Aviv, 69710, Israel

  • Baruch Padeh MC

    RECRUITING

    Ramat Poriya, 1520800, Israel

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Bnai Zion Medical Center

    RECRUITING

    Haifa, 31048, Israel

  • Box Hill Hospital

    RECRUITING

    Box Hill, 3128, Australia

  • British Columbia Cancer Agency

    RECRUITING

    Vancouver, British Columbia, V5Z4E6, Canada

  • CHRU de Lille Hopital Claude Huriez

    RECRUITING

    Lille, 59000, France

  • CHRU de Tours

    RECRUITING

    Tours, 37000, France

  • CHU De Poitiers

    RECRUITING

    Poitiers, 86021, France

  • CHU Toulouse

    RECRUITING

    Toulouse, 31300, France

  • CHU de Bordeaux - Hospital Haut-Leveque

    RECRUITING

    Pessac, 33600, France

  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Campus Bio Medico di Roma

    RECRUITING

    Roma, 00128, Italy

  • Cardiff and Vale UHB - University Hospital of Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Carmel Medical Center

    RECRUITING

    Haifa, 34362, Israel

  • Casa Sollievo Della Sofferenza IRCCS

    RECRUITING

    San Giovanni Rotondo, 71013, Italy

  • Chiba Cancer Center

    RECRUITING

    Chiba, 260 0801, Japan

  • City of Hope Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • City of Hope Duarte

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • Clinica Medica Sao Germano LTDA

    RECRUITING

    São Paulo, 04537 081, Brazil

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Durham VAMC

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Erasmus MC

    RECRUITING

    Rotterdam, 3015, Netherlands

  • Evangelismos S A

    RECRUITING

    Athens, 106 76, Greece

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, 6150, Australia

  • First affiliated Hospital of Zhejiang University

    RECRUITING

    Hangzhou, 310003, China

  • Florida Cancer Specialists & Research Institute

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    RECRUITING

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    RECRUITING

    São Paulo, 01509 900, Brazil

  • Fundacao Universidade de Caxias do Sul

    RECRUITING

    Caxias do Sul, 95070 560, Brazil

  • Funfarme Sjrp

    RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • Geniko Nosokomeio Thessalonikis George Papanikolaou

    RECRUITING

    Thessaloniki, 570 10, Greece

  • Gold Coast University Hospital

    RECRUITING

    Southport, 4215, Australia

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

    RECRUITING

    Florianópolis, 88020 210, Brazil

  • H. Vall D'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Haga ziekenhuis

    RECRUITING

    The Hague, 2545 AA, Netherlands

  • Hopital Saint Louis APHP

    RECRUITING

    Paris, 75010, France

  • Hosp Clinico Univ de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hosp de Galdakao

    RECRUITING

    Usansolo, 48960, Spain

  • Hosp. Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hosp. Quiron Madrid Pozuelo

    RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hosp. Univ. Germans Trias I Pujol

    RECRUITING

    Badalona, 08916, Spain

  • Hosp. Univ. I Politecni La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hosp. Univ. Virgen de Las Nieves

    RECRUITING

    Granada, 18014, Spain

  • Hospices Civils de Lyon HCL

    RECRUITING

    Lyon, 69002, France

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    RECRUITING

    Curitiba, 81520-060, Brazil

  • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP

    RECRUITING

    Campinas, 13083-888, Brazil

  • Hotel Dieu CHU de Nantes

    RECRUITING

    Nantes, 44000, France

  • Humanitas Hospital

    RECRUITING

    Rozzano, 20089, Italy

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IDOR - Regional Bahia

    RECRUITING

    Salvador, 41253-190, Brazil

  • IDOR - Regional Sao Paulo

    RECRUITING

    São Paulo, 01401 002, Brazil

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

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

    RECRUITING

    Rio de Janeiro, 22775 001, Brazil

  • Japanese Red Cross Medical Center

    RECRUITING

    Shibuya City, 150-8935, Japan

  • Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V5C2, Canada

  • Kameda Medical Center

    RECRUITING

    Kamogawa, 296-8602, Japan

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, 241 8515, Japan

  • Kent and Canterbury Hospital

    RECRUITING

    Canterbury, CT1 3NG, United Kingdom

  • Laura and Isaac Perlmutter Cancer Center NYU ACC

    RECRUITING

    New York, New York, 10016, United States

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Marien Hospital Dusseldorf

    RECRUITING

    Düsseldorf, 40479, Germany

  • Mater Misericordiae Ltd

    RECRUITING

    Brisbane, 4101, Australia

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Phoenix

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College Of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Mission Cancer Blood

    RECRUITING

    Waukee, Iowa, 50263, United States

  • Moffit Cancer center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Monash Medical Centre

    RECRUITING

    Clayton, 3168, Australia

  • Mount Sinai Brooklyn

    RECRUITING

    Brooklyn, New York, 11234, United States

  • Mount Sinai Chelsea

    RECRUITING

    New York, New York, 10011, United States

  • NYU Winthrop

    RECRUITING

    Mineola, New York, 11501, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, 210008, China

  • Ninewells Hospital & Medical School

    RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Nottingham City Hospital

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Oregon Health And Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Oslo University Hospital HF Ulleval sykehus

    RECRUITING

    Oslo, 0450, Norway

  • Ospedale Santa Chiara AO Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

  • Peking University First Hospital

    RECRUITING

    Beijing, 100034, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, 100044, China

  • Queen Alexandra Hospital

    RECRUITING

    Portsmouth, PO6 3LY, United Kingdom

  • Queen Elizabeth II Health Sciences Centre

    RECRUITING

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Radboud Umcn

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109601, Israel

  • Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Shaare Zedek MC

    RECRUITING

    Jerusalem, 9103102, Israel

  • Shanghai Fourth People s Hospital

    RECRUITING

    Shanghai, 200434, China

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 52621, Israel

  • Shonan Kamakura General Hospital

    RECRUITING

    Kamakura-shi, 247-8533, Japan

  • Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, 610032, China

  • Sir Charles Gairdner Hospital

    RECRUITING

    Nedlands, 6009, Australia

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652 900, Brazil

  • Soroka Medical Center

    RECRUITING

    Beersheba, 8457108, Israel

  • Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • St Vincents Hospital Melbourne

    RECRUITING

    Fitzroy, 3065, Australia

  • St. Antonius Ziekenhuis Nieuwegein

    RECRUITING

    Nieuwegein, 3435 CM, Netherlands

  • St. David's South Austin Medical Center

    RECRUITING

    Austin, Texas, 78704, United States

  • St. Olavs Hospital

    RECRUITING

    Trondheim, 7030, Norway

  • Stavanger University Hospital Ullandhaug

    RECRUITING

    Stavanger, 4021, Norway

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, 510060, China

  • Texas Transplant Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, 3004, Australia

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, 530021, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, 325000, China

  • The Jikei University Hospital

    RECRUITING

    Minato, 105-8471, Japan

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, 710006, China

  • Theageneio Cancer Hospital

    RECRUITING

    Thessaloniki, 546 39, Greece

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    RECRUITING

    Bunkyō City, 113 8677, Japan

  • U.O. Ematologia Ospedale San Bortolo

    RECRUITING

    Vicenza, 36100, Italy

  • UAMS

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, 97080, Germany

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Universitatsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • University College London Hospitals

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Health Network UHN Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94122, United States

  • University of Connecticut Health Center

    RECRUITING

    Farmington, Connecticut, 06030, United States

  • University of Iowa Hospital and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Maryland School of Medicine

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • VU Medisch Centrum

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Yamanashi Prefectural Central Hospital

    RECRUITING

    Kofu, 400-0027, Japan

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