NCT02726750Recruiting
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 30 Mar 2016
- Start date
- 14 Dec 2015
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Multiple myeloma
- NCT number
- NCT02726750
What you commit to
- Study type: Observational
- Planned participants: 200
- From 14 Dec 2015 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements
Lab values
- 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)
Other
- Plasma cell leukemia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.