Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353022
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-22
Brief Title:
Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab Bortezomib Lenalidomide and Dexamethasone D-VRd in Newly Diagnosed Multiple Myeloma
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab Bortezomib Lenalidomide and Dexamethasone D-VRd in Newly Diagnosed Multiple Myeloma A Phase 2 IFM 2022-01
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
IFm2022-01
Brief Summary:
This is a Phase 2 study open-label 2-cohort multicenter national interventional in patients with newly diagnosed multiple myeloma The study will investigate teclistamab Tec in combination with lenalidomide Len Tec-Len Cohort A or in combination with talquetamab Tal Tec-Tal Cohort B allocated based on minimal residual disease MRD status MRD - standard-risk vs MRD high-risk respectively
The patient population will consist of adults men and women at least 18 years to younger than 66 years of age who meet eligibility criteria
The patient population will consist of adults men and women at least 18 years to younger than 66 years of age who meet eligibility criteria
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 2023-508310-41 | EUDRACT_NUMBER | None | None |