A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab — Cycle 1 (28 days cycle): Predose to Day 7 postdose
Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose). - Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose — Cycle 1 (28 days cycle): Predose to Day 7 postdose
AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose). - Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1 — Cycle 3 (28 days cycle): Day 1
Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration.
Trial sites (53)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
Other trials for the same condition
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 Italy