Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-05-06 @ 8:28 PM
Study NCT ID:
NCT06399393
Status:
Recruiting
Last Update Posted:
May 3 2024
First Post:
May 1 2024
Brief Title:
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Randomized Open-Label Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation KarMMa-9
Status:
Recruiting
Status Verified Date:
May 2024
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KarMMa-9
Brief Summary:
The purpose of this study is to compare the efficacy safety and tolerability of ide-cel with lenalidomide LEN maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma NDMM who have achieved a suboptimal response post autologous stem cell transplantation ASCT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| U1111-1280-9736 | Other Identifier | WHO | None |