Clinical trial · Observational
A Single-centre Prospective Study to Explore the Role of Frailty in Patients With Multiple Myeloma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 biological parameters will be collected by interviewing the patients via questionnaires, physical tests and blood analyses. All these will be done during routine visits of the patients' care pathway, minimising the impact on patient lifestyles. The patients will then be stratified according to the geriatric assessment into 3 groups (fit, non-fit, frail) and the changes to these parameters will be compared within these 3 groups throughout the treatment and the follow-up phase for a minimum of 24 months. The markers of frailty will also be measured in a group of healthy subjects and the results will be compared with those of patients with MM. The characterisation of markers of frailty will be a starting point to develop strategies to reduce the causes of frailty, hence it will reduce the treatment-related toxicity, improve quality of life and eventually the outcome for patients with MM.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Healthy Subjects
- description
- To compare the markers of frailty (MoF) in patients with multiple myeloma (MM) with the healthy subjects.
- label
- MM Patients
- description
- Patients with multiple myeloma (MM), the aim is to assess if any of the proposed parameters and markers of frailty (e.g. biomarkers of cellular senescence and organ damage, inflammatory markers, physical tests such as gait speed and hand grip test) are associated with frailty status, defined according to the GA, at baseline.
Primary outcomes (6)
- measure
- Frailty status defined according to Geriatric assessment
- timeFrame
- 18 months from Recruitment End
- description
- Katz Activity of Daily Living (ADL) Questionnaires with a points scale of 1 or 0, with 0 dependence and 1 independence
- measure
- Frailty status defined according to biomarkers of frailty: Teleomere Length
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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)
References
Publications (0)
Data not yet available