NCT02726750

Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Monoclonal Gammopathy of Undetermined Significance
• Smoldering Plasma Cell Myeloma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2015-12-14
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2016-04-04
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States