Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

NCT05136807 | Recruiting

• 2 other identifiers: 2016-0172NCI-2021-11118
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoldering Plasma Cell Myeloma; Monoclonal Gammopathy of Undetermined Significance

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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; Other: Questionnaire Administration

Interventions

Quality-of-Life Assessment OTHER

Complete questionnaires

Also known as: Quality of Life Assessment

Observational (quality of life questionnaire)

Questionnaire Administration OTHER

Complete questionnaires

Observational (quality of life questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Neoplasms

Study Officials

• Melody E Becnel

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melody Becnel, MD

CONTACT

832-206-9804; mrbecnel@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 29, 2021
• Study Start: June 7, 2016
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)