Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

ConditionsMonoclonal Gammopathy of Undetermined Significance Smoldering Plasma Cell Myeloma

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

This trial does not accept healthy volunteers

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 population

Patients with monoclonal gammopathy of unknown significance or smoldering multiple myeloma at MD Anderson Cancer Center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Quality-of-Life Assessment
Other intervention
Complete questionnaires
Questionnaire Administration
Other intervention
Complete questionnaires

Treatment groups

400 Participants

are divided into 1 treatment group

Group A: Observational (quality of life questionnaire)2 interventions

Trial outcomes

Primary outcomes

Quality of life questionnaires

Patients complete quality of life questionnaires over 10-15 minutes at baseline. Score scale ranges from (1-4) 1 - Not at all and 4 - Almost all the time

Time frame

Up to 3 years

Quality of life questionnaires

Patients complete quality of life questionnaires every 6 months for patients participating in an observational study or every month for patients participating in a treatment study for up to 3 years. Score scale ranges from (1-4) 1 - Not at all and 4 - Almost all the time

Time frame

Up to 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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