Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413498
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-09
Brief Title:
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed Refractory Multiple Myeloma
Sponsor:
Kite A Gilead Company
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 3 Randomized Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With RelapsedRefractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-10
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:
iMMagine-3
Brief Summary:
The goal of this study iMMagine-3 is to compare the study drug anitocabtagene autoleucel to standard of care therapy SOCT in participants with relapsedrefractory multiple myeloma who have received 1 to 3 prior lines of therapy including an anti-CD38 monoclonal antibody and an immunomodulatory drug
The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM as measured by progression-free survival PFS per blinded independent review committee IRC
The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM as measured by progression-free survival PFS per blinded independent review committee IRC
Detailed Description:
After completing the treatment period all participants who will receive anitocabtagene autoleucel will be followed in the post-treatment follow-up period Thereafter participants will transition to a separate long-term follow-up study KT-US-982-5968 to continue follow-up out to 15 years
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 |
|---|---|---|---|
| 2024-511188-26 | OTHER | European Medicines Agency | None |