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

Mayo Clinic

Status: Completed

Conditions: Plasma Cell Myeloma

Treatments: Other: Electronic Health Record Review; Other: Comprehensive Geriatric Assessment; Procedure: Biospecimen Collection; Other: Survey Administration

Study type: Observational

Funder types: Other

Identifiers

NCT05918185

21-010499 (Other Identifier)

NCI-2022-06872 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >= 65 years
• Diagnosis of MM based on International Myeloma Working Group (IMWG) diagnostic criteria
• Newly diagnosed or have received 1 prior line of treatment
• Planned to start a new treatment for MM within 30 days
• Transplant eligible or ineligible
• Fluent in English (all assessment tools are in English)
• Able to provide written informed consent

Exclusion criteria

• Received > 1 prior line of treatment
• Patients included in an interventional therapeutic trial
• Not able to give informed consent
• Severe mental or cognitive disorder precluding geriatric assessment

Trial design

56 participants in 1 patient group

Observational (Surveys, cGA, blood sample, EHR review)

Description:

Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study.

Treatment:

Other: Survey Administration

Other: Comprehensive Geriatric Assessment

Procedure: Biospecimen Collection

Other: Electronic Health Record Review