Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Other illness

• Presence of cognitive impairment or delirium as determined by the primary clinician.

Lab values

• 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)

Other

• Plasma cell leukemia.

• 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.