Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-04 @ 4:37 PM
Study NCT ID:
NCT02726750
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)
Status:
RECRUITING
Status Verified Date:
2025-10
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:
The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Studying markers such as age, level of proteins in blood, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities may help researchers to validate clinical and genomic predictors for future use in clinical practice.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the rate of progression to multiple myeloma after 3 years of follow up.
SECONDARY OBJECTIVES:
I. To describe baseline patient characteristics and clinical variables. II. To identify molecular and genetic correlates that may predict for progression to multiple myeloma (MM).
OUTLINE:
Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, positron emission tomography (PET)/computed tomography (CT) scans, and/or magnetic resonance imaging (MRI) scans to check the status of disease at the discretion of the treating physician.
After completion of 3 years on study, patients are followed up every 6-12 months thereafter.
I. To determine the rate of progression to multiple myeloma after 3 years of follow up.
SECONDARY OBJECTIVES:
I. To describe baseline patient characteristics and clinical variables. II. To identify molecular and genetic correlates that may predict for progression to multiple myeloma (MM).
OUTLINE:
Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, positron emission tomography (PET)/computed tomography (CT) scans, and/or magnetic resonance imaging (MRI) scans to check the status of disease at the discretion of the treating physician.
After completion of 3 years on study, patients are followed up every 6-12 months thereafter.
Study Oversight
Has Oversight DMC:
False
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?: