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Double antibody attack shows promise for Hard-to-Treat myeloma

NCT ID NCT04586426

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a combination of two experimental drugs, talquetamab and teclistamab, in people with multiple myeloma that has come back or stopped responding to other treatments. The goal is to find the safest and most effective dose and to see how well the drugs shrink tumors. About 228 participants will take part across three parts of the study.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

228 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Oct 2026

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 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen * Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration Exclusion Criteria: * All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy * All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment. * All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. * All Parts: Active plasma cell leukemia (greater than \[\>\]2.0\*10\^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

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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

Contacts and locations

Locations

  • Alberta Health Services

    Edmonton, Alberta, T6G 1Z2, Canada

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Atrium Health

    Charlotte, North Carolina, 28204, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hadassah Medical Center

    Jerusalem, 91120, Israel

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08908, Spain

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935, Japan

  • Kanazawa University Hospital

    Kanazawa, 920-8641, Japan

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Nagoya City University Hospital

    Nagoya, 467 8602, Japan

  • Oregon Health And Science University

    Portland, Oregon, 97239, United States

  • Osaka University Hospital

    Osaka, 565-0871, Japan

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1X6, Canada

  • Royal Perth Hospital

    Perth, 6000, Australia

  • 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

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • St Vincents Hospital Melbourne

    Fitzroy, 3065, Australia

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • UNIV. HOSP. October 12

    Madrid, 28041, Spain

  • University of Alabama at Birmingham, Comprehensive Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

  • Washington University St. Louis School Medicine Siteman Cancer Center

    St Louis, Missouri, 63108, United States

More trials for these conditions

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