RecruitingNCT05136807

Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Sponsor

M.D. Anderson Cancer Center

Enrollment

400 participants

Start Date

Jun 7, 2016

Study Type

OBSERVATIONAL

Conditions

Monoclonal Gammopathy of Undetermined Significance Smoldering Plasma Cell Myeloma

Summary

This study examines the quality of life in patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma. Collecting quality of life information from patients may help doctors learn more about the most common symptoms and concerns patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma may have.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria10

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.