Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Monoclonal Gammopathy of Undetermined Significance Clinical Trial

Official title:

Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136807
• Other study ID #: 2016-0172
• Secondary ID: NCI-2021-1111820
• Status: Recruiting
• Start date: June 7, 2016
• Est. completion date: February 2, 2027

Study information

• Verified date: September 2023
• Source: M.D. Anderson Cancer Center
• Contact: Mei Huang
• Phone: 713-745-9901
• Email: mhuang3[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE: I. 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: I. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Monoclonal Gammopathy of Undetermined Significance
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Smoldering Multiple Myeloma
• Smoldering Plasma Cell Myeloma

Intervention

Other:
• Quality-of-Life Assessment
Complete questionnaires
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 3 years
Primary	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	Up to 3 years

External Links

•   M D Anderson Cancer Center