Evaluation of Comprehensive Geriatric Assessment and Laboratory Biomarkers in Elderly Patients With Multiple Myeloma
NCT ID: NCT05918185
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
56 participants
OBSERVATIONAL
2023-02-15
2025-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Geriatric Assessments in Senior Adults With Multiple Myeloma
NCT01746030
Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients
NCT02918695
Etiology of Multiple Myeloma: A Case-Control Study
NCT00505999
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Myeloma (SMM)
NCT01109407
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
NCT06365060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Observational (Surveys, cGA, blood sample, EHR review)
Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study.
Biospecimen Collection
Undergo blood sample collection
Comprehensive Geriatric Assessment
Undergo cGA
Electronic Health Record Review
Medical records are reviewed
Survey Administration
Complete surveys
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biospecimen Collection
Undergo blood sample collection
Comprehensive Geriatric Assessment
Undergo cGA
Electronic Health Record Review
Medical records are reviewed
Survey Administration
Complete surveys
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patients included in an interventional therapeutic trial
* Not able to give informed consent
* Severe mental or cognitive disorder precluding geriatric assessment
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shaji K. Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2022-06872
Identifier Type: REGISTRY
Identifier Source: secondary_id
21-010499
Identifier Type: OTHER
Identifier Source: secondary_id
21-010499
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.