To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluation of Comprehensive Geriatric Assessment and Laboratory Biomarkers in Elderly Patients with Multiple Myeloma
NCT ID:
NCT05918185
Condition:
Plasma Cell Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Observational (Surveys, cGA, blood sample, EHR review)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Comprehensive Geriatric Assessment
Description:
Undergo cGA
Arm group label:
Observational (Surveys, cGA, blood sample, EHR review)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Medical records are reviewed
Arm group label:
Observational (Surveys, cGA, blood sample, EHR review)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete surveys
Arm group label:
Observational (Surveys, cGA, blood sample, EHR review)
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.
Criteria for eligibility:
Study pop:
Patients over the age of 65 planned to start a new treatment for MM at Mayo Clinic in
Rochester.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Shaji K. Kumar, MD
Start date:
February 15, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05918185
