Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

This study is looking at the quality of life for people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). These are conditions where abnormal proteins are found in the blood, but you might not have symptoms. Researchers want to understand the most common symptoms and concerns you might have by asking you to complete questionnaires. This information could help doctors learn how to better support patients in the future. You may be able to join if you are 18 or older and have been diagnosed with MGUS or SMM, with specific levels of abnormal proteins and no signs of active myeloma or amyloidosis.

Study design: This is an observational study planning to enroll 400 participants. It aims to describe quality of life and anxiety in patients with MGUS/SMM.
What's involved: You would complete quality of life questionnaires, which take 10-15 minutes, at the start of the study. Depending on your other study participation, you would complete them every month or every 6 months for up to 3 years.
Compensation: Not stated in the trial record.
Follow-up: You would be followed for up to 3 years, completing questionnaires during this time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Recruiting

Not specifiedAges 18+Observational

M.D. Anderson Cancer Center

~400 participants

Updated 2026-04-15 on ClinicalTrials.gov

What's tested:Quality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Quality of life questionnaires

Measured over Up to 3 years

+1 more outcome measured

Conditions

Monoclonal Gammopathy of Undetermined Significance

Smoldering Plasma Cell Myeloma

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Melody E Becnel · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Melody Becnel, MD

[email protected]

832-206-9804

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Quality of life questionnairesUp 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 questionnairesUp 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

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