Trials / Active Not Recruiting
Active Not RecruitingNCT06425991
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teclistamab | Teclistamab will be administered subcutaneously. |
Timeline
- Start date
- 2024-06-07
- Primary completion
- 2027-02-28
- Completion
- 2027-03-03
- First posted
- 2024-05-23
- Last updated
- 2026-04-13
Locations
53 sites across 11 countries: United States, Australia, Canada, France, Germany, Israel, Italy, Poland, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06425991. Inclusion in this directory is not an endorsement.