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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plasma Cell Myeloma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Other: Electronic Health Record Review; Other: Comprehensive Geriatric Assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Shaji K. Kumar, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Complete surveys; Other: Electronic Health Record Review; Medical records are reviewed; Other: Comprehensive Geriatric Assessment; Undergo cGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Shaji K. Kumar, M.D., Mayo Clinic in Rochester

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 21-010499 (Other Identifier: Mayo Clinic in Rochester); NCI-2022-06872 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No