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Active (not recruiting) Phase 1 NCT06425991

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

Phase 1 – testing safety in a small group of people
Conditions: Relapsed or Refractory Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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).
Who can participate
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
Locations 11
Australia (1)
Flinders Medical Centre
Bedford Park
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
France (1)
CHRU de Lille Hopital Claude Huriez
Lille
Germany (1)
Klinikum Chemnitz gGmbH
Chemnitz
Israel (1)
Carmel Medical Center
Haifa
Italy (1)
Ospedali Riuniti Di Ancona
Ancona
Poland (1)
Wojewodzki Szpital Specjalistyczny
Biała Podlaska
South Korea (1)
Seoul National University Hospital
Seoul
Spain (1)
Hosp Clinic de Barcelona
Barcelona
United Kingdom (1)
Hammersmith Hospital
London
United States (1)
Banner MD Anderson Cancer Center
Gilbert , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.06.2024
Completion date
03.03.2027
Registry ID
NCT06425991
Source
anzctr
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