Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05136807

Conditions

Monoclonal Gammopathy of Undetermined Significance

Smoldering Plasma Cell Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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

Monoclonal Gammopathy of Undetermined Significance

Smoldering Plasma Cell Myeloma

Study ID

NCT05136807

Start date

Jun 7, 2016

Status verified date

Apr, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Quality-of-Life Assessment

Complete questionnaires

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Quality of life questionnaires [ Time Frame: Up to 3 years ]
  • Quality of life questionnaires [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Melody Becnel, MD

832-206-9804mrbecnel@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Mei Huang

713-745-9901mhuang3@mdanderson.org

Principal Investigator:

Elisabet E. Manasanch

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.