A Single-centre Prospective Study to Explore the Role of Frailty in Patients With Multiple Myeloma.

NCT04683393 | Completed DMC

• 2 other identifiers: MMM-FRAILTY16R04443
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

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 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

Multiple Myeloma

Outcome Measures

Primary Outcomes (6)

• Frailty status defined according to Geriatric assessment

  Katz Activity of Daily Living (ADL) Questionnaires with a points scale of 1 or 0, with 0 dependence and 1 independence

  18 months from Recruitment End

• Frailty status defined according to biomarkers of frailty: Teleomere Length

  Biomarkers: Telomere length analysis: on leukocytes and bone marrow by QPCR via the method of Cawthon

  18 months from Recruitment End

• Frailty status defined according to biomarkers of frailty: miRNAs

  Biomarkers:miRNAs expression leukocytes via relative quantitative real-time PCR (qRT-PCR)

  18 months from Recruitment End

• Frailty status defined according to biomarkers of frailty: CDKN2A

  Biomarkers: CDKN2A expression on leukocytes via relative quantitative real-time PCR (qRT-PCR)

  18 months from Recruitment End

• Frailty status defined according to Geriatric assessment

  Lawton Instrumental Activity of Daily Living (IADL) Activities of daily living scale.Patients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men

  18 months from Recruitment End

• Frailty status defined according to Geriatric assessment

  Charlson Comorbidity Index (CCI). Predicts 10 year survival in patients with multiple comorbidities. Scale is No 0, Yes is plus score depending on disease. Lower the overall points the greater survival rate

  18 months from Recruitment End

Study Arms (2)

Healthy Subjects

To compare the markers of frailty (MoF) in patients with multiple myeloma (MM) with the healthy subjects.

MM Patients

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria EXPLICITLY state otherwise. Participants with the above characteristics are eligible:

You may qualify if:

• 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.
• Aged 50 years or greater
• Able to provide written informed consent

You may not qualify if:

• Not able to give informed consent
• MGUS or sMM without MDE
• 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
• Not able to give informed consent
• History of past or present cancer requiring treatment (surgery and/or radiotherapy and/or chemotherapy)

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples collected at baseline and throughout the study will also be stored for future studies to allow a prompt evaluation of novel biomarkers identified in the future, and therefore to accelerate the validation of these biomarkers. Routine blood assessments will be performed at the Manchester Royal Infirmary (MRI) laboratory as per clinical routine. Serum and leukocytes samples will be stored in multiple aliquots at -80oC to test future potential markers. The samples will be processed and stored at Manchester Royal Infirmary (MRI) in the laboratory of Dr Burthem. Samples will be then shipped in dry ice once a year to Glasgow to the laboratory of Prof Shiels for analysis.

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: December 24, 2020
• Study Start: October 3, 2016
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 24, 2024

Record last verified: 2024-01