Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207799
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-01-05
Brief Title:
Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
Status:
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:
To learn if giving elranatamab before and after an autologous stem cell transplant ASTC can help to control newly diagnosed high-risk MM An ASTC is a type of transplant in which a persons own stem cells are collected preserved and returned to them
Detailed Description:
Primary Objectives
To determine the overall proportion of high-risk MM participants achieving sustained MRD-negative CR status after the completion of the treatment plan including in-vivo purging with elranatamab auto-HCT and post-transplant maintenance therapy Sustained MRD-negativity is defined as MRD-negative status in two assessments at least 1-year apart without any MRD-positive status in between
To determine the proportion of patients with clonal plasma cell negative autograft collection in participants with high-risk MM
Secondary Objectives
To assess the impact of elranatamab on hematopoietic progenitor cell mobilization and collection yield
To determine the safety and tolerability of elranatamab plus lenalidomide maintenance therapy after auto-HCT
To detect the MRD-negative rate before auto-HCT with in-vivo purging using elranatamab
To detect the MRD-negative rate after auto-HCT
To determine overall response rates as defined by the International Myeloma Working Group IMWG
To determine the PFS and OS with elranatamab plus lenalidomide maintenance therapy after auto-HCT in participants with high-risk NDMM
To determine the PFS and OS in participants with high-risk NDMM who discontinue maintenance therapy after achieving CR plus sustained MRD-negative status
To determine the PFS and OS with elranatamab plus lena
To determine the overall proportion of high-risk MM participants achieving sustained MRD-negative CR status after the completion of the treatment plan including in-vivo purging with elranatamab auto-HCT and post-transplant maintenance therapy Sustained MRD-negativity is defined as MRD-negative status in two assessments at least 1-year apart without any MRD-positive status in between
To determine the proportion of patients with clonal plasma cell negative autograft collection in participants with high-risk MM
Secondary Objectives
To assess the impact of elranatamab on hematopoietic progenitor cell mobilization and collection yield
To determine the safety and tolerability of elranatamab plus lenalidomide maintenance therapy after auto-HCT
To detect the MRD-negative rate before auto-HCT with in-vivo purging using elranatamab
To detect the MRD-negative rate after auto-HCT
To determine overall response rates as defined by the International Myeloma Working Group IMWG
To determine the PFS and OS with elranatamab plus lenalidomide maintenance therapy after auto-HCT in participants with high-risk NDMM
To determine the PFS and OS in participants with high-risk NDMM who discontinue maintenance therapy after achieving CR plus sustained MRD-negative status
To determine the PFS and OS with elranatamab plus lena
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 |
|---|---|---|---|
| NCI-2024-00110 | OTHER | NCI-CTRP Clinical Registry | None |