Clinical trial NCT05918185: Evaluation of Comprehensive Geriatric Assessment and Laboratory Biomarkers in Elderly Patients With Multiple Myeloma
Official title: The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plasma Cell Myeloma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 65 planned to start a new treatment for MM at Mayo Clinic in Rochester.

Brief 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.

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

Primary outcomes:
measure: Incidence of treatment-related adverse events
timeFrame: Up to 4 months
Secondary outcomes:
measure: Chemotherapy toxicity
timeFrame: Up to 4 months
measure: Patient reported outcome (PRO) questionnaire
timeFrame: Up to 4 months
measure: Patient reported outcome (PRO-CTCAE) questionnaire
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Shaji K. Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: