Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549634
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Biomarkers of AKI in Patients Receiving Daratumumab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Biomarkers of AKI in Patients With Multiple Myeloma Receiving Daratumumab A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The goal of this prospective observational study is to understand changes in urinary and blood biomarkers associated with acute kidney injury AKI in patients newly diagnosed with multiple myeloma and being treated with Daratumumab SC The aims of the study are
To measure changes in plasma and urinary biomarkers of AKI before initiation of Daratumumab therapy and 30 days after initiation of therapy
To establish whether these biomarkers serve to aid in early detection and prevention of AKI
Participants will give urine and blood samples at their normally scheduled lab appointments
To measure changes in plasma and urinary biomarkers of AKI before initiation of Daratumumab therapy and 30 days after initiation of therapy
To establish whether these biomarkers serve to aid in early detection and prevention of AKI
Participants will give urine and blood samples at their normally scheduled lab appointments
Detailed Description:
Serum creatinine is an insensitive marker of AKI often rising late and after significant injury has already occurred A number of novel markers have recently been shown to have utility in the early detection of AKI These markers have shown promise in preclinical and human studies in multiple other clinical settings eg cardiac surgery coronary angiography critical illness but have not been studied in the context of multiple myeloma Specifically elevated pre-procedural plasma levels of soluble urokinase-type plasminogen activator receptor suPAR the circulating form of a membrane-bound protein expressed by immunologically active cells have been demonstrated to be predictive of AKI patients undergoing coronary angiography cardiac surgery and in critically ill patients Hayek et al NEJM 2020 and levels rise early after injury Similarly urinary levels of Dickkoph-3 DKK3 a stress-induced tubular epithelia-derived glycoprotein have been demonstrated to predict AKI after cardiac surgery and following administration of iodinated contrast Schunk et al Lancet 2019
The aim of this study is to conduct a pilot prospective non-interventional study testing changes in novel plasma and urinary biomarkers of kidney injury in patients with newly-diagnosed multiple myeloma treated with daratumumab who are at risk for AKI
The hypothesis is that patients with multiple myeloma and at risk for developing AKI but without AKI at baseline will have at least a 10 decline in plasma soluble urokinase-type plasminogen activator receptor and urinary levels of Dickkoph-3 following treatment with daratumumab
The primary outcomes will be changes in plasma suPAR and urinary levels of DKK3 between treatment initiation of daratumumab day 0 or up to 7 days prior and day 30 -7 days from the time of treatment initiation
The aim of this study is to conduct a pilot prospective non-interventional study testing changes in novel plasma and urinary biomarkers of kidney injury in patients with newly-diagnosed multiple myeloma treated with daratumumab who are at risk for AKI
The hypothesis is that patients with multiple myeloma and at risk for developing AKI but without AKI at baseline will have at least a 10 decline in plasma soluble urokinase-type plasminogen activator receptor and urinary levels of Dickkoph-3 following treatment with daratumumab
The primary outcomes will be changes in plasma suPAR and urinary levels of DKK3 between treatment initiation of daratumumab day 0 or up to 7 days prior and day 30 -7 days from the time of treatment initiation
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