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Will a new recipe for a myeloma drug pass the test?

NCT ID NCT06425991

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study compares two versions of the drug teclistamab—one made with the current process and one with a new process—in 108 people with multiple myeloma that has come back or not responded to treatment. The main goal is to see if the body absorbs and handles both versions the same way. Participants receive the drug as a shot under the skin, and researchers will also monitor immune responses and tumor shrinkage.

What this could mean

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

Active substance
Teclistamab (a drug given as a shot under the skin)
What this could lead to
If successful, this study could confirm that the new manufacturing process produces teclistamab that works just as well, ensuring a stable supply for patients.
What could go wrong
This is an early-phase study focused on drug levels in the body, not on proving the drug works better. It is small and may not show meaningful differences in how patients feel or their outcomes.

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

108 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Jan 2028

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 diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line * Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria * Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2 * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study Exclusion Criteria: * Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients * Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed * Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required * Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

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

Multiple myeloma Relapsed or refractory multiple myeloma

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Augusta University- Georgia Cancer Center

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Box Hill Hospital

    Box Hill, 3128, Australia

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604, France

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090, Poland

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53-439, Poland

  • Epworth Healthcare

    Richmond, 3121, Australia

  • Flinders Medical Centre

    Bedford Park, 5042, Australia

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 9112001, Israel

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hospices Civils de Lyon HCL

    Lyon, 69002, France

  • ICO L'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014, Italy

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113, Germany

  • Norfolk & Norwich University Hospital

    Norwich, NR4 7UY, United Kingdom

  • Ospedale Santa Chiara AO Universitaria Pisana

    Pisa, 56126, Italy

  • Ospedali Riuniti Di Ancona

    Ancona, 60126, Italy

  • Policlinico Universitario Agostino Gemelli

    Rome, 00168, Italy

  • Pratia Onkologia Katowice

    Katowice, 40 519, Poland

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1X6, Canada

  • Royal Prince Alfred Hospital

    Camperdown, 2050, 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, 5266202, Israel

  • Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health

    Indianapolis, Indiana, 46237, United States

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734, Poland

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591, South Korea

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20251, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • Wojewodzki Szpital Specjalistyczny

    Biała Podlaska, 21 500, Poland

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