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

Plasma Cell Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918185
• Other study ID #: 21-010499
• Secondary ID: NCI-2022-0687221
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Procedure:
• Biospecimen Collection
Undergo blood sample collection

Other:
• Comprehensive Geriatric Assessment
Undergo cGA
• Electronic Health Record Review
Medical records are reviewed
• Survey Administration
Complete surveys

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related adverse events	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.	Up to 4 months
Secondary	Chemotherapy toxicity	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.	Up to 4 months
Secondary	Patient reported outcome (PRO) questionnaire	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.	Up to 4 months
Secondary	Patient reported outcome (PRO-CTCAE) questionnaire	Select PRO-CTCAE symptomatic adverse event items to assess the presence, severity and interference of symptoms experienced by patients.	Up to 4 months