RecruitingNCT02726750

Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

200 participants

Start Date

Dec 14, 2015

Study Type

OBSERVATIONAL

Conditions

Monoclonal Gammopathy of Undetermined Significance Smoldering Plasma Cell Myeloma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria14

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