Assessing quality of life in patients with asymptomatic monoclonal gammopathies
Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
This study looks at how living with monoclonal gammopathy of undetermined significance and smoldering multiple myeloma affects people's quality of life and anxiety over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | Isatuximab, Pembrolizumab |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05136807 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with either MGUS or SMM who are already participating in clinical trials at MD Anderson Cancer Center.
Not a fit: Patients with symptomatic multiple myeloma or those not enrolled in clinical trials for MGUS or SMM may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies and interventions for patients with MGUS and SMM, enhancing their quality of life.
How similar studies have performed: While this approach is observational, similar studies have successfully highlighted quality of life issues in cancer populations, suggesting potential for meaningful insights in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.