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
- Diseases
- Multiple myeloma
- 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
Sites (51)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Epworth Healthcare Coordinator of this site? Confirm its status | Richmond | Australia | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Princess Margaret Cancer Centre - University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust - Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Norfolk & Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah University Hospita Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Coordinator of this site? Confirm its status | Biala Podlaska | Poland | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Active, not recruiting |
| Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Augusta University, Georgia Cancer Center Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Cleveland Clinic Florida Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.