Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425991
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-17
Brief Title:
A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 1 Randomized Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With RelapsedRefractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MajesTEC-10
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508426-10-00 | REGISTRY | EUCT number | None |
| 64007957MMY1008 | OTHER | None | None |
| 2023-508426-10 | EUDRACT_NUMBER | None | None |