Evaluating Geriatric Assessments and Biomarkers in Older Patients with Multiple Myeloma
The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study
Mayo Clinic · NCT05918185
This study is testing how a detailed health check and lab tests can help understand the side effects of chemotherapy in older patients with multiple myeloma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05918185 on ClinicalTrials.gov |
What this trial studies
This observational study assesses how a comprehensive geriatric assessment (cGA) and laboratory biomarkers relate to chemotherapy side effects in older patients with multiple myeloma (MM). The cGA evaluates various health domains, including physical and mental health, to determine patient fitness. Researchers will analyze the association between cGA results and treatment-related adverse events, patient-reported outcomes, and treatment discontinuation over the first four months of chemotherapy. Additionally, the study will explore changes in cGA over time and their correlation with treatment response, aiming to enhance personalized treatment approaches for older adults with MM.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 years and above who are newly diagnosed with multiple myeloma or have received one prior line of treatment.
Not a fit: Patients who have received more than one prior line of treatment or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that minimize chemotherapy side effects in older patients with multiple myeloma.
How similar studies have performed: Other studies have shown promise in using geriatric assessments to predict treatment outcomes in older cancer patients, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Shaji K. Kumar, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Plasma Cell Myeloma