Studies quality of life in people with early plasma cell conditions
Collects questionnaires on quality of life from adults with early blood plasma cell conditions.
Key facts
- Who runs it
- M.D. Anderson Cancer Center
- Where
- Houston, United StatesSee the site
- Trial code
- Registry title
- Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- 7 Jun 2016
- Expected to end
- 2 Feb 2027
- Type of study
- Observational
- Treatments tested
- Quality-of-Life Assessment
- Questionnaire Administration
- Record updated
- 6 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma who are already in an MD Anderson Cancer Center trial for these conditions. Quality of life is studied with questionnaires.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- MGUS: serum monoclonal protein < 3 g/dL or urinary monoclonal protein < 500 mg per 24 hours, and clonal bone marrow plasma cells < 10%. Smoldering multiple myeloma: serum monoclonal protein >= 3 g/dL or urinary monoclonal protein >= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%. No myeloma defining events or amyloidosis.
Main reasons for not taking part
- Signs of myeloma defining events, such as high calcium, kidney problems, anemia or bone lesions
- Clonal bone marrow plasma cell percentage >= 60%
- Plasma cell leukemia
- Cognitive impairment or delirium
- Not English or Spanish speaking
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Presence of cognitive impairment or delirium as determined by the primary clinician
- 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
Where in United States
- M D Anderson Cancer CenterHouston, United StatesContact: Mei HuangTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- 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.
Treatment: Quality-of-Life Assessment and Questionnaire Administration
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
- Plain-language title
- Studies quality of life in people with early plasma cell conditionsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 October 2026