Evaluation of Comprehensive Geriatric Assessment and Laboratory Biomarkers in Elderly Patients With Multiple Myeloma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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:
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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.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (Surveys, cGA, blood sample, EHR review) Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study. |
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Comprehensive Geriatric Assessment
Undergo cGA
Other: Electronic Health Record Review
Medical records are reviewed
Other: Survey Administration
Complete surveys
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-related adverse events [Up to 4 months]
Will graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum observed grade per adverse event and capture grade >= 3 toxicities.
Secondary Outcome Measures
- Chemotherapy toxicity [Up to 4 months]
Will be analyzed longitudinally using toxicity over time analysis which measures adverse events over time, providing information on timing and evolution of symptoms during treatment.
- Patient reported outcome (PRO) questionnaire [Up to 4 months]
Will be assessed at the end of each treatment cycle (prior to each new cycle) at scheduled visits for a total of 4 months or until treatment discontinuation whichever comes first using the PRO Measurement Information System Global Health which is a 10-item questionnaire that assesses a patient's global heath. All questions have a five-point Likert-type scale, except for the rating of pain question which has a 10-point scale. Subscale scores can be generated for Global Physical Health and Global Mental for each patient.
- Patient reported outcome (PRO-CTCAE) questionnaire [Up to 4 months]
Select PRO-CTCAE symptomatic adverse event items to assess the presence, severity and interference of symptoms experienced by patients.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >= 65 years
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Diagnosis of MM based on International Myeloma Working Group (IMWG) diagnostic criteria
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Newly diagnosed or have received 1 prior line of treatment
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Planned to start a new treatment for MM within 30 days
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Transplant eligible or ineligible
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Fluent in English (all assessment tools are in English)
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Able to provide written informed consent
Exclusion Criteria:
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Received > 1 prior line of treatment
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Patients included in an interventional therapeutic trial
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Not able to give informed consent
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Severe mental or cognitive disorder precluding geriatric assessment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Shaji K Kumar, Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-010499
- NCI-2022-06872
- 21-010499