Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT05164250
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2025-11-10
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
None
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2025-10
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:
None
Brief Summary:
Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma
Detailed Description:
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: