Assessing quality of life in patients with asymptomatic monoclonal gammopathies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on evaluating the quality of life in patients diagnosed with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). Participants will complete quality of life questionnaires at baseline and periodically over a three-year period to track changes and identify common symptoms and concerns. The study aims to gather valuable data that may inform future treatment and intervention strategies for these patients. By understanding the quality of life and anxiety levels associated with MGUS and SMM, researchers hope to enhance patient care.

Why it matters

Who can join: the full rules

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.

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Melody E Becnel — M.D. Anderson Cancer Center
• Study coordinator: Melody Becnel, MD
• Email: mrbecnel@mdanderson.org
• Phone: 832-206-9804

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Exploring the effects of a plant-based diet and supplements on smoldering multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.