Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Launched by M.D. ANDERSON CANCER CENTER · Nov 23, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how the quality of life is affected in patients with two specific conditions called monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). These conditions are related to abnormal proteins in the blood and can lead to more serious issues, but at this stage, many patients do not have noticeable symptoms. By gathering information from patients about their everyday experiences and concerns, the researchers hope to better understand what challenges these individuals face.

To be eligible for the trial, participants must be at least 18 years old and meet specific health criteria related to their condition. They should either have MGUS with low levels of abnormal proteins or SMM with slightly higher levels but no serious complications. Participants will need to be enrolled in certain clinical trials at MD Anderson Cancer Center and should be able to speak English or Spanish. Those who take part in the study can expect to share their experiences and may help improve care for others with similar conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with either monoclonal gammopathy of unknown significance age \>= 18 years old.
• * 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
• • OR Patients with smoldering multiple myeloma age \>= 18 years old.
• * 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
• • Patients must be enrolled in clinical trials for SMM or MGUS at MD Anderson Cancer Center, including protocols PA15-0575 (NCT02726750) (Prospective observational study of clinical and genomic predictors of progression to myeloma in asymptomatic monoclonal gammopathies); 2015-0148 (Phase II single arm trial of Isatuximab in patients with intermediate and high risk smoldering multiple myeloma); and 2015-0371 (NCT02603887) (Pilot single arm, single center, open label trial of Pembrolizumab in patients with intermediate and high risk smoldering multiple myeloma) and any future clinical trials for MGUS and/or SMM that open at MD Anderson Cancer Center.
• • Only patients who are English or Spanish speaking are eligible.
• 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, if the patient has an MRI done per eligibility criteria (each focal lesion must be 5 mm or more in size)
• • Plasma cell leukemia.
• • Presence of cognitive impairment or delirium as determined by the primary clinician.