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A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
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).
Official title: A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2024-06-07
Completion Date
2027-03-03
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Teclistamab
Teclistamab will be administered subcutaneously.
Locations (53)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Cleveland Clinic Florida
Weston, Florida, United States
Augusta University- Georgia Cancer Center
Augusta, Georgia, United States
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health
Indianapolis, Indiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
Baylor University Medical Center
Dallas, Texas, United States
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, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
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
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea
Hosp Clinic de Barcelona
Barcelona, Spain
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain
Hammersmith Hospital
London, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom
Norfolk & Norwich University Hospital
Norwich, United Kingdom
Derriford Hospital
Plymouth, United Kingdom