NCT05918185

Evaluation of Comprehensive Geriatric Assessment and Laboratory Biomarkers in Elderly Patients With Multiple Myeloma

The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Comprehensive Geriatric Assessment	Undergo cGA
OTHER	Electronic Health Record Review	Medical records are reviewed
OTHER	Survey Administration	Complete surveys

Timeline

• Start date: 2023-02-15
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2023-06-26
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States