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New combo therapy aims to control multiple myeloma

NCT ID NCT05050097

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-phase study tests the safety of talquetamab combined with other cancer drugs in 166 people with multiple myeloma, a type of blood cancer. The goal is to find safe doses and check for side effects. Participants must have measurable disease and meet specific lab criteria.

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

166 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Apr 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 * Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level \>= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration * A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration * Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program Exclusion Criteria: * Live, attenuated vaccine within 4 weeks 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 * History of stroke or seizure within 6 months prior to the first dose of 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

Contacts and locations

Locations

  • Alfred Health

    Melbourne, 3004, Australia

  • CHU Nantes

    Nantes, 44093, France

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604, France

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000, France

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Gold Coast University Hospital

    Southport, 4215, Australia

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Maastricht University Medical Centre

    Maastricht, 6229 HX, Netherlands

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Mt. Sinai School of Medicine

    New York, New York, 10029, 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

  • UMCG

    Groningen, 9713 GZ, Netherlands

  • UMCU

    Utrecht, 3584 CX, Netherlands

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • UZA

    Edegem, 2650, Belgium

  • University College Hospital London

    London, W1T 7HA, United Kingdom

  • University of Alabama 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

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Wollongong Hospital

    Wollongong, 2500, Australia

More trials for these conditions

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