Status:
COMPLETED
A Single-centre Prospective Study to Explore the Role of Frailty in Patients With Multiple Myeloma.
Lead Sponsor:
Manchester University NHS Foundation Trust
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to explore the markers of frailty in a "real world" population of MM patients, and to monitor changes to those markers throughout treatment and follow-up. Clinical, physical and biolog...
Detailed Description
This project aims to characterize the markers of frailty in a population of MM patients in a "real world" setting. The clinical approach to the patients (i.e. treatment schedule, number of appointment...
Eligibility Criteria
Inclusion
- Aged 18 years or greater
- Newly diagnosed or relapse/refractory patients with multiple myeloma including non-secretory multiple myeloma. If patients are at diagnosis, they need to have a myeloma defining events (MDE) as reported in Appendix B. If they are at relapse they need to meet the criteria for relapse as per Appendix C.
- Patients due to start any anti-myeloma treatment irrespectively from the line of treatment
- Able to provide written informed consent
- Patients enrolled in other clinical trials can be enrolled in this study. Patients will not attend the hospital more frequently if enrolled in this study. In fact all the assessment, tests and questionnaires will be done whilst the patients are attending the hospital for routine appointments.
- Inclusion criteria for healthy subjects:
- Aged 50 years or greater
- Able to provide written informed consent
Exclusion
- Not able to give informed consent
- MGUS or sMM without MDE
- Patients receiving ongoing treatment for MM with the exclusion of steroids (maximal dose of Dexamethasone 160 mg in last 2 weeks or equivalent) and radiotherapy for spinal cord compression (SCC). The reason for this exclusion is that the baseline measurements need to be done before starting a proper line of chemotherapy and not in the middle of a treatment in order to be comparable between patients.
- Patient received allogeneic stem cell transplant at any stage of treatment. The reason being that some markers (i.e. telomere length) can consistently change following an allogeneic stem cell transplant
- Exclusion criteria for healthy subjects:
- Not able to give informed consent
- History of past or present cancer requiring treatment (surgery and/or radiotherapy and/or chemotherapy)
Key Trial Info
Start Date :
October 3 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04683393
Start Date
October 3 2016
End Date
June 30 2022
Last Update
January 24 2024
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