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New combo therapy aims to control multiple myeloma

NCT ID NCT04722146

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 4 times

Summary

This early-stage study tests a new drug called teclistamab combined with other cancer treatments for people with multiple myeloma, a type of blood cancer. The main goal is to check safety and find the best doses. About 140 participants who have already tried other treatments will take part.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

140 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Oct 2027

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: * Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria * Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab \[tec\]-daratumumab \[dara\]-pomalidomide \[pom\]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide \[len\]-bortezomib \[bor\]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat \[niro\]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (\>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma * Have measurable disease at screening as defined by at least one of the following: serum M-protein level \>= 1.0 gram/deciliter (g/dL); or urine M-protein level \>= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[hCG\]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study * A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study treatment Exclusion Criteria: * Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C * Live, attenuated vaccine within 30 days before the first dose of study treatment * Received a cumulative dose of corticosteroids equivalent to \>= 140 mg of prednisone within the 14-day period before the start of study treatment administration * Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required * Known to be seropositive for human immunodeficiency virus

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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

  • Alfred Health

    Melbourne, 3004, Australia

  • CHU Nantes

    Nantes, 44093, France

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604, France

  • Calvary Mater Newcastle Hospital

    Waratah, 2298, Australia

  • Centre Leon Berard

    Lyon, 69373, France

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000, France

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021, United States

  • St Vincents Hospital Melbourne

    Fitzroy, 3065, Australia

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • The Christie Nhs Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Trust Sutton

    Surrey, SM2 5PT, United Kingdom

  • UZ Gent

    Ghent, 9000, Belgium

  • UZA

    Edegem, 2650, Belgium

  • University College Hospital

    London, NW1 2BU, United Kingdom

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Washington University School Of Medicine

    St Louis, Missouri, 63110-1032, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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