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

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

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.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Observational Trial

Enrollment: 100 patients (estimated)

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Trial Locations

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Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting
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