Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-26 @ 8:05 PM
Study NCT ID:
NCT04991103
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Residual Disease Response-adapted Deferral of Transplant in Dysproteinemia (MILESTONE)
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Minimal Residual Disease Response-adapted Deferral of Transplant in Dysproteinemia - MILESTONE Trial
Status:
RECRUITING
Status Verified Date:
2024-11
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:
None
Brief Summary:
This is a phase II interventional study evaluating the use of minimal residual disease by next generation sequencing to defer autologous hematopoietic stem cell transplantation (AHCT) in patients with newly diagnosed multiple myeloma.
Detailed Description:
While AHCT is an important treatment strategy for patients with multiple myeloma, from a safety standpoint, AHCT is associated with both acute toxicities that reduce quality of life and long-term toxicities that may limit life expectancy for some patients. Additionally its benefit in patients without evidence of minimal residual disease (MRD) is unknown.
We propose to examine MRD response as a strategy to defer AHCT in a systematic manner.
We propose to examine MRD response as a strategy to defer AHCT in a systematic manner.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: