Studies markers that may predict myeloma in people with early plasma cell conditions
Observes people with early plasma cell disorders to find markers of progression to myeloma.
Plain-language title generated from the registry record
Registry title: Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
Key facts
- Where
- Houston, United StatesSee the site
Where in United States
- M D Anderson Cancer CenterHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- M.D. Anderson Cancer Center
- Trial code
- NCT02726750
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)
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.
Inclusion: Patients with monoclonal gammopathy of unknown significance. Both criteria must be met:; Serum monoclonal protein < 3 g/dL or urinary monoclonal protein < 500 mg per 24 hours and clonal bone marrow plasma cells < 10%; Absence of myeloma defining events or amyloidosis; Patients with smoldering multiple myeloma. Both criteria must be met:; Serum monoclonal protein >= 3 g/dL or urinary monoclonal protein >= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%; Absence of myeloma defining events or amyloidosis.
Exclusion: Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies; Bisphosphonates are permitted; Radiotherapy is not permitted; Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted; Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements; Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following; Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL); Renal Insufficiency: creatinine clearance < 40 ml/min or serum creatinine > 2 mg/dL; Anemia: hemoglobin value < 10 g/dL or 2 g/dL < normal reference; Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2[F-18] fluoro-D-glucose positron emission tomography CT (PET-CT); Clonal bone marrow plasma cell percentage >= 60%; Involved:uninvolved serum free light chain ratio >= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom [UK]); > 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size); Plasma cell leukemia.