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The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study
This study evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (MM). The comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. It is composed of a series of questions and tests designed for older people to evaluate their physical function, mental status, mental health, nutritional status, social support, level of social activity, and the presence of other medical problems. In addition to geriatric assessment domains, laboratory biomarkers may provide information on physiologic dysfunction as a measure for evaluation of frailty in the cancer setting. This study will help researchers in the future by predicting which patients will have more side effects with chemotherapy based on their comprehensive geriatric assessment and laboratory biomarkers, which will allow adjustments to treatment in older adult patients with MM.
PRIMARY OBJECTIVE: I. To evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (\>= 65 years) with multiple myeloma (MM). SECONDARY OBJECTIVES: I. To evaluate the association between a baseline cGA and baseline disease- and host- related laboratory characteristics and cytogenetic risk profile by fluorescence in situ hybridization among newly diagnosed older (\>= 65 years) patients with MM. II. To evaluate how the cGA changes over 4 months from the start of treatment and the association between those changes and treatment response in older patients (\>= 65 years) with MM. III. To evaluate the association between proposed frailty biomarkers at baseline and treatment toxicity in the first 4 months of treatment measured by treatment-related adverse events, PROs, and treatment discontinuation in older (\>= 65 years) patients with MM. OUTLINE: This is an observational study. Patients complete surveys and undergo cGA, blood sample collection, and electronic health record (EHR) review on study.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Start Date
February 15, 2023
Primary Completion Date
August 30, 2025
Completion Date
August 30, 2025
Last Updated
February 3, 2026
56
ACTUAL participants
Biospecimen Collection
PROCEDURE
Comprehensive Geriatric Assessment
OTHER
Electronic Health Record Review
OTHER
Survey Administration
OTHER
Lead Sponsor
Mayo Clinic
NCT06356571
NCT05334069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05312255