Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT02726750
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
* 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
* Plasma cell leukemia
* Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02726750
Study Brief:
Protocol Section:
NCT02726750