Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

Launched by M.D. ANDERSON CANCER CENTER · Apr 1, 2016

Keywords

ClinConnect Summary

This clinical trial is studying patients with two specific conditions: monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). Both conditions involve abnormal proteins in the blood or bone marrow but do not yet show symptoms of multiple myeloma, which is a type of cancer. The researchers want to understand why some patients with these conditions go on to develop multiple myeloma while others do not. They will look at various factors, such as age, blood protein levels, and genetics, to identify potential markers that could help predict the risk of developing the disease in the future.

To participate in this study, individuals must be between the ages of 65 and 74 and have either MGUS or SMM based on specific criteria. For example, those with MGUS should have low levels of abnormal proteins and bone marrow plasma cells, while those with SMM should have higher protein levels or more abnormal cells. Participants will not be receiving treatment but will be monitored to gather data that could improve understanding and management of these conditions. It’s important to know that individuals with certain serious health issues or prior treatments for these conditions may not be eligible for the trial.

Gender

ALL

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