Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06655818
Status:
TERMINATED
Last Update Posted:
2025-03-03
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5. Sub-study 4 - Belantamab Mafodotin and Dostarlimab (GSK4057190) in Combination
Status:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to lack of efficacy
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03763370
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each combination treatment to explore in the cohort expansion phase. This study is a sub study of the Master protocol (NCT04126200).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-001138-32 | EUDRACT_NUMBER | None | View |