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New antibody drug shows promise for Hard-to-Treat myeloma

NCT ID NCT04634552

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new drug called talquetamab in people with multiple myeloma that has come back or stopped responding to treatment. Talquetamab is a bispecific antibody designed to help the immune system attack cancer cells. The trial aims to find the best dose and see how well it shrinks tumors. About 510 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Talquetamab (a bispecific antibody that helps immune cells attack myeloma cells)
What this could lead to
If successful, this could provide a new treatment option for people with multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial, so the drug may not work for everyone or could cause serious side effects. The study is still recruiting, and results are not yet known.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 510 people

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

Started

Feb 2021

Expected to finish

Mar 2029

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 initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria * Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin \[hCG\]) or urine * Willing and able to adhere to the prohibitions and restrictions specified in this protocol Exclusion Criteria: * Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Received a cumulative dose of corticosteroids equivalent to \>= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication) * Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm plasma cell myeloma

As listed by the trial registrant

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

Hematological malignancies

How to take part

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

  1. The places running it

    14 sites in 2 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

  • Asan Medical Center

    COMPLETED

    Seoul, 05505, South Korea

  • C.H.U. Hotel Dieu - France

    ACTIVE_NOT_RECRUITING

    Nantes, 44093, France

  • CHU Henri Mondor

    ACTIVE_NOT_RECRUITING

    Créteil, 94000, France

  • CHU de Bordeaux - Hospital Haut-Leveque

    ACTIVE_NOT_RECRUITING

    Pessac, 33604, France

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    ACTIVE_NOT_RECRUITING

    Liège, 4000, Belgium

  • CHU de Montpellier Hopital Saint Eloi

    ACTIVE_NOT_RECRUITING

    Montpellier, 34295, France

  • Carmel Medical Center

    ACTIVE_NOT_RECRUITING

    Haifa, 3436212, Israel

  • Charite Campus Benjamin Franklin

    ACTIVE_NOT_RECRUITING

    Berlin, 12203, Germany

  • Chonnam National University Hwasun Hospital

    COMPLETED

    Jeollanam-do, 58128, South Korea

  • City of Hope

    COMPLETED

    Duarte, California, 91010, United States

  • Clinica Univ. de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Dokkyo Medical University Saitama Medical Center

    COMPLETED

    Koshigaya, 343-8555, Japan

  • Emory University Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • First Affiliated Hospital SooChow University

    ACTIVE_NOT_RECRUITING

    Suzhou, 215006, China

  • Fukuoka University Hospital

    COMPLETED

    Fukuoka, 814-0180, Japan

  • Hadassah Medical Center

    ACTIVE_NOT_RECRUITING

    Jerusalem, 91120, Israel

  • Hosp Clinico Univ de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    COMPLETED

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hosp. Quiron Madrid Pozuelo

    COMPLETED

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. 12 de Octubre

    ACTIVE_NOT_RECRUITING

    Madrid, 28041, Spain

  • Hosp. Univ. Germans Trias I Pujol

    COMPLETED

    Badalona, 08916, Spain

  • Hosp. Univ. Marques de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hosp. Univ. Virgen de La Arrixaca

    ACTIVE_NOT_RECRUITING

    Murcia, 30120, Spain

  • Hosp. Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospices Civils de Lyon HCL

    ACTIVE_NOT_RECRUITING

    Lyon, 69002, France

  • Inst. Cat. Doncologia-H Duran I Reynals

    ACTIVE_NOT_RECRUITING

    Barcelona, 8908, Spain

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

    ACTIVE_NOT_RECRUITING

    Tianjin, 300320, China

  • Iwate Medical University Hospital

    COMPLETED

    Shiwa-gun, 028-3695, Japan

  • Japanese Red Cross Osaka Hospital

    COMPLETED

    Osaka, 543 8555, Japan

  • Kameda Medical Center

    COMPLETED

    Chiba, 296-8602, Japan

  • Kobe City Medical Center General Hospital

    COMPLETED

    Kobe, 650 0047, Japan

  • Kumamoto University Hospital

    COMPLETED

    Kumamoto, 860-8556, Japan

  • Kurashiki Central Hospital

    COMPLETED

    Kurashiki, 710-8602, Japan

  • Memorial Healthcare System

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Mount Sinai Medical Center

    RECRUITING

    New York, New York, 10023, United States

  • NYU Langone Health

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    COMPLETED

    Warsaw, 02-781, Poland

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

    COMPLETED

    Gliwice, 44102, Poland

  • National Hospital Organization Hiroshima-Nishi Medical Center

    ACTIVE_NOT_RECRUITING

    Ōtake, 739-0696, Japan

  • National Hospital Organization Matsumoto Medical Center

    COMPLETED

    Matsumoto, 399-8701, Japan

  • National Hospital Organization Okayama Medical Center

    COMPLETED

    Okayama, 701-1192, Japan

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Ogaki Municipal Hospital

    COMPLETED

    Gifu, 503-8502, Japan

  • Peking University Third Hospital

    ACTIVE_NOT_RECRUITING

    Beijing, 100191, China

  • Providence Portland Medical Center

    COMPLETED

    Portland, Oregon, 97213, United States

  • Pôle IUC Oncopole CHU

    ACTIVE_NOT_RECRUITING

    Toulouse, 31059, France

  • Rambam Medical Center

    ACTIVE_NOT_RECRUITING

    Haifa, 31096, Israel

  • Samsung Medical Center

    COMPLETED

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    COMPLETED

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    COMPLETED

    Seoul, 03722, South Korea

  • Sheba Medical Center

    ACTIVE_NOT_RECRUITING

    Ramat Gan, 52621, Israel

  • Sun Yat Sen University Cancer Center

    ACTIVE_NOT_RECRUITING

    Guangzhou, 510060, China

  • Teine Keijinkai Hospital

    COMPLETED

    Hokkaido, 006-8555, Japan

  • Tel Aviv Sourasky Medical Center

    ACTIVE_NOT_RECRUITING

    Tel Aviv, 64239, Israel

  • Tennessee Oncology

    COMPLETED

    Nashville, Tennessee, 37203, United States

  • The 1St Affiliated Hospital of Medical College Zhejiang University

    ACTIVE_NOT_RECRUITING

    Hangzhou, 310003, China

  • The 1st Affiliated Hospital Of Medical College Zhejiang University 1

    ACTIVE_NOT_RECRUITING

    Hangzhou, 310003, China

  • The Catholic University of Korea Seoul St Marys Hospital

    COMPLETED

    Seoul, 06591, South Korea

  • The First Affiliated Hospital of Xian Jiaotong University

    COMPLETED

    Xi'an, 710063, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    COMPLETED

    Xi'an, 710004, China

  • UCL - Saint Luc

    COMPLETED

    Woluwe-Saint-Lambert, 1200, Belgium

  • UMCU

    COMPLETED

    Utrecht, 3584 CX, Netherlands

  • UZ Antwerpen

    COMPLETED

    Edegem, 2650, Belgium

  • UZ Leuven

    ACTIVE_NOT_RECRUITING

    Leuven, 3000, Belgium

  • Universitaetsklinikum Heidelberg

    ACTIVE_NOT_RECRUITING

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Muenster

    COMPLETED

    Münster, 48149, Germany

  • Universitatsklinikum Wurzburg

    ACTIVE_NOT_RECRUITING

    Würzburg, 97080, Germany

  • University of Alabama Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Chicago

    COMPLETED

    Chicago, Illinois, 60637, United States

  • University of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    ACTIVE_NOT_RECRUITING

    Wroclaw, 50 367, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    ACTIVE_NOT_RECRUITING

    Poznan, 60-569, Poland

  • Uniwersyteckie Centrum Kliniczne

    ACTIVE_NOT_RECRUITING

    Gdansk, 80 214, Poland

  • VU Medisch Centrum

    COMPLETED

    Amsterdam, 1081 HV, Netherlands

  • Washington University School Of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

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