Multiple Myeloma Clinical Trial

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

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.

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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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

100

Study ID:

NCT05918185

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Clinical Trials Referral Office
Contact
855-776-0015
[email protected]
Shaji K. Kumar, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

100

Study ID:

NCT05918185

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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