Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523621
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nivolumab As An Adjunctive Therapy In Relapsed Refractory Multiple Myeloma Patients With Sub-Optimal Response To Idecabtagene Vicleucel
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This study is designed to evaluate if treatment with adjuvant nivolumab improves depth of response in patients with relapsed refractory multiple myeloma RRMM who achieve a less-than-ideal response to idecaptagene vicleucel
Detailed Description:
This is a single arm two-stage Phase II of adjuvant nivolumab in patients with RRMM treated with at least 2 prior lines of therapy and are refractory to or intolerant of at least one proteasome inhibitor PI one immunomodulatory agent IMiD and one anti-CD38 antibody who achieved a sub-optimal response defined as a VGPR PR MR or SD by IMWG 2016 criteria to treatment with idecabtagene vicleucel
This study will determine best overall response after 2 cycles of adjuvant nivolumab given every 4 weeks in patient who achieve a sub-optimal response to ide-celon restaging studies 30 days after infusion The Investigators will also evaluate for changes in CAR-T cell expansion persistence of CAR-T cells and additional toxicity compared to historical controls
This study will determine best overall response after 2 cycles of adjuvant nivolumab given every 4 weeks in patient who achieve a sub-optimal response to ide-celon restaging studies 30 days after infusion The Investigators will also evaluate for changes in CAR-T cell expansion persistence of CAR-T cells and additional toxicity compared to historical controls
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