Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04196491
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2019-12-10
Brief Title:
A Study to Evaluate the Safety of bb2121 in Subjects With High Risk Newly Diagnosed Multiple Myeloma NDMM
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 1 Open-label Multicenter Study to Evaluate the Safety of bb2121 in Subjects With High Risk Newly Diagnosed Multiple Myeloma KarMMa-4
Status:
COMPLETED
Status Verified Date:
2023-08
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:
KarMMa-4
Brief Summary:
This is a multicenter open-label phase 1 single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR R-ISS Stage III per IMWG criteria NDMM Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of the drug product bb2121 Following manufacture of the drug product subjects will receive fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion Maintenance therapy is recommended for all subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion whichever is later
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1243-5088 | OTHER | WHO | None |