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Clinical Trials in the UK / NCT06425991
Active, not recruiting Phase 1

A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT06425991 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2024-06-07
Last updated
2026-08-28

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Teclistamab

Teclistamab: Teclistamab will be administered subcutaneously.

Study summary

The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona
Colorado Blood Cancer Institute Denver Colorado
Cleveland Clinic Florida Weston Florida
Augusta University- Georgia Cancer Center Augusta Georgia
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health Indianapolis Indiana
Cleveland Clinic Cleveland Ohio
Baylor University Medical Center Dallas Texas
Flinders Medical Centre Bedford Park Australia
Box Hill Hospital Box Hill Australia
Royal Prince Alfred Hospital Camperdown Australia
Epworth Healthcare Richmond Australia
Cross Cancer Institute Edmonton Alberta
Princess Margaret Cancer Centre University Health Network Toronto Ontario
CHRU de Lille Hopital Claude Huriez Lille France
Hospices Civils de Lyon HCL Lyon France
CHU Nantes Nantes France
CHU de Bordeaux - Hospital Haut-Leveque Pessac France
Klinikum Chemnitz gGmbH Chemnitz Germany
Universitaetsklinikum Hamburg Eppendorf Hamburg Germany
Universitaetsklinikum Heidelberg Heidelberg Germany
Universitatsklinikum Wurzburg Würzburg Germany
Carmel Medical Center Haifa Israel
Hadassah University Hospita Ein Kerem Jerusalem Israel
Sheba Medical Center Ramat Gan Israel
Sourasky Medical Center Tel Aviv Israel
Ospedali Riuniti Di Ancona Ancona Italy
ASST Papa Giovanni XXIII Bergamo Bergamo Italy
Azienda Ospedaliera Spedali Civili di Brescia Brescia Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy
Ospedale Santa Chiara AO Universitaria Pisana Pisa Italy
Policlinico Universitario Agostino Gemelli Rome Italy
Wojewodzki Szpital Specjalistyczny Biała Podlaska Poland
Uniwersyteckie Centrum Kliniczne Gdansk Poland
Pratia Onkologia Katowice Katowice Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Lublin Poland
Dolnoslaskie Centrum Onkologii Wroclaw Poland
Seoul National University Hospital Seoul South Korea
Severance Hospital Yonsei University Health System Seoul South Korea
Asan Medical Center Seoul South Korea

+ 13 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06425991 on ClinicalTrials.gov ↗ ← All trials in the UK