Sarcopenia Impact Among Older Patients With Newly Diagnosed Multiple Myeloma
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-009493
Sponsor Protocol Number: 22-009493
About this study
The purpose of this study is to evaluate the association between baseline sarcopenia and high-grade chemotherapy toxicity during the first 4 cycles of treatment measured by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0, the Patient-Reported Outcomes (PRO) version of the CTCAE(PRO-CTCAE), and treatment discontinuation in older patients (≥60 years) with hematologic malignancies.
The hypothesis is that for older patients with hematologic malignanclies, sarcopenia is associated with higher likelihood of high-grade treatment-related chemotherapy toxicity and a higher rate of treatment discontinuation during the first 4 cycles of treatment.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 60 years.
- Post-menopausal status - determined by self-reported last menstrual period ≥ 1 year ago, and/or history of hysterectomy +/- bilateral oophorectomy.
- Diagnosis of Multiple Myeloma (MM) based on IMWG diagnostic criteria, leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic myelomonocytic leukemia) myelodysplastic syndrome, lymphoma (non-hodgkins lymphoma, hodgkins lymphoma).
- Planned to start a new treatment within 30 days at Mayo Clinic in Rochester, MN. Patients who are receiving treatment at a location other than Mayo Clinic in Rochester, MN but undergoing evaluation prior to each cycle at Mayo Clinic in Rochester, MN.
- Transplant eligible or ineligible.
- Fluent in English (all assessment tools are in English).
- Able to provide written informed consent.
Exclusion Criteria:
- Not able to give informed consent.
Eligibility last updated 7/10/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available