Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365060
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-07
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:
In this multicenter study we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma SMM a group of patients for whom standard of care is observation not treatment The main goal of this study is to screen for the diagnosis of light-chain amyloidosis AL before the onset of symptomatic disease and to develop a training set for a likelihood algorithm
Detailed Description:
This study is based on results from two prior studies in which 4 of 36 patients with SMM and none of 14 patients with MGUS were found to have AL The hypothesis that we test with this protocol is that patients with 1 a pre-existing diagnosis of SMM 2 free light chain FLC abnormalities 3 IGLV genes associated with AL4 t1114 or gain 1q and 5 NT-proBNP 332pgmL will have undiagnosed AL or risk of progression to AL We will study the potential for SMM the FLC screen AL-related IGLV gene use t1114 or gain 1q cytogenetic abnormalities and NT-proBNP 332pgmL to be the variables in a likelihood algorithm for AL
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 |
|---|---|---|---|
| R01CA279808 | NIH | None | httpsreporternihgovquickSearchR01CA279808 |