Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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 criteria
Qualifiers
Patients with either monoclonal gammopathy of unknown significance age >= 18 years old.
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Quality-of-Life Assessment
- Questionnaire Administration
Treatment groups
400 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov