Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05136807

Collaborator

National Cancer Institute (NCI) (NIH)

400

Enrollment

Location

78.8

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Monoclonal Gammopathy of Undetermined Significance Smoldering Plasma Cell Myeloma	Other: Quality-of-Life Assessment Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:

Describe baseline and follow up quality of life and monoclonal gammopathy of unknown significance/smoldering multiple myeloma (MGUS/SMM) related anxiety of patients with MGUS/SMM already participating in clinical trials at MD Anderson Cancer Center.

SECONDARY OBJECTIVE:

Identify the most common symptoms/patients concerns to evaluate future interventions for treatment/prevention in this population.

OUTLINE:

Patients complete quality of life questionnaires over 10-15 minutes at baseline and 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Actual Study Start Date :

Jun 7, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Observational (quality of life questionnaire) Patients complete quality of life questionnaires over 10-15 minutes at baseline and 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.	Other: Quality-of-Life Assessment Complete questionnaires Other Names: Quality of Life Assessment Other: Questionnaire Administration Complete questionnaires

Arm

Intervention/Treatment

Observational (quality of life questionnaire)

Other: Quality-of-Life Assessment

Complete questionnaires

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Complete questionnaires

Outcome Measures

Primary Outcome Measures

Quality of life questionnaires [Up to 3 years]
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
Quality of life questionnaires [Up to 3 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.