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

NCT05918185 | Completed

• 2 other identifiers: 21-010499NCI-2022-06872
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Chemotherapy toxicity

  Up to 4 months

• Patient reported outcome (PRO) questionnaire

  Up to 4 months

• Patient reported outcome (PRO-CTCAE) questionnaire

  Up to 4 months

Study Arms (1)

Observational (Surveys, cGA, blood sample, EHR review)

Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study.

Procedure: Biospecimen Collection; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (Surveys, cGA, blood sample, EHR review)

Comprehensive Geriatric Assessment OTHER

Undergo cGA

Observational (Surveys, cGA, blood sample, EHR review)

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (Surveys, cGA, blood sample, EHR review)

Survey Administration OTHER

Complete surveys

Observational (Surveys, cGA, blood sample, EHR review)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Specimen Handling; Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Shaji K. Kumar, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 26, 2023
• Study Start: February 15, 2023
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)