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NCT06425991Active, not recruitingPhase 1

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

A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
108 (actual)
First submitted
17 May 2024
Start date
7 Jun 2024
Primary completion date
21 Apr 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06425991
EU CT number
2023-508426-10-00

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 108
  • From 7 Jun 2024 to the primary completion date, 21 Apr 2025
  • 51 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy
  • 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
  • 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

Other illness

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Box Hill Hospital
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Box HillAustraliaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
Epworth Healthcare
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RichmondAustraliaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
Princess Margaret Cancer Centre - University Health Network
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TorontoCanadaUnknown status
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Hammersmith Hospital
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust - Christie Hospital
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ManchesterUnited KingdomUnknown status
Norfolk & Norwich University Hospital
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NorwichUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Hadassah University Hospita Ein Kerem
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Sourasky Medical Center
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
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Biala PodlaskaPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandActive, not recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandActive, not recruiting
Medical University of Warsaw
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WarsawPolandActive, not recruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandActive, not recruiting
Augusta University, Georgia Cancer Center
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AugustaUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
Banner MD Anderson Cancer Center
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GilbertUnited StatesUnknown status
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health
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IndianapolisUnited StatesUnknown status
Cleveland Clinic Florida
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WestonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.