Multiple MyelomaNCT04683393
A Single-centre Prospective Study to Explore the Role of Frailty in Patients With Multiple Myeloma.
An observational study of Multiple Myeloma, run by Manchester University NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2016to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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:
Who may be able to join
- 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
Who cannot join
- 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
- Not able to give informed consent
- History of past or present cancer requiring treatment (surgery and/or radiotherapy and/or chemotherapy)
About this study
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.
Read the 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 appointments in the hospital, invasive procedures) will not be changed compared to patients not enrolling in the study.
In particular, the primary objective of the study is:
To explore measures of frailty in MM patients: 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.
The secondary objectives of the study are:
- To monitor frailty (defined by GA) and those markers of frailty (MoF) over time and evaluate treatment effects on frailty and MoF: this will explore the relationship between the markers of frailty and the tumor. Moreover, this will allow the study to assess if the frailty score at baseline is static or can be modified, in particular to observe whether frailty is improved in patients responding well to the treatment without toxicity.
- To explore the relationship of parameters and biomarkers of frailty with: treatment-related toxicity, treatment discontinuation, response to treatment, PFS and OS
- To investigate the predictive role of GA in the "real world" setting: the GA has been assessed in 3 clinical trials in more than 800 patients, but no data are available on the "real world" population where frail patients are more frequently encountered.
- To compare the MoF in patients with MM with the healthy subjects.
- To assess the relation of frailty and quality of life (QoL): in elderly and frail MM patients the QoL is one of the most important (if not the most important) objective for treatment. Investigators will investigate if the QoL perceived by the patient relates to the frailty assessment and how this varies over time.
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.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 18 months from Recruitment End
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start3 Oct 2016
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683393
- Sponsor's protocol ID
- MMM-FRAILTY16
- Other IDs
- R04443
- Status last verified
- Jan 2024
- First submitted
- 22 Oct 2020
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre Prospective Study to Explore the Role of Frailty in Patients With Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT04683393
- Acronym / sponsor ID
- MMM-FRAILTY16
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 appointments in the hospital, invasive procedures) will not be changed compared to patients not enrolling in the study.
In particular, the primary objective of the study is:
To explore measures of frailty in MM patients: 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.
The secondary objectives of the study are:
- To monitor frailty (defined by GA) and those markers of frailty (MoF) over time and evaluate treatment effects on frailty and MoF: this will explore the relationship between the markers of frailty and the tumor. Moreover, this will allow the study to assess if the frailty score at baseline is static or can be modified, in particular to observe whether frailty is improved in patients responding well to the treatment without toxicity.
- To explore the relationship of parameters and biomarkers of frailty with: treatment-related toxicity, treatment discontinuation, response to treatment, PFS and OS
- To investigate the predictive role of GA in the "real world" setting: the GA has been assessed in 3 clinical trials in more than 800 patients, but no data are available on the "real world" population where frail patients are more frequently encountered.
- To compare the MoF in patients with MM with the healthy subjects.
- To assess the relation of frailty and quality of life (QoL): in elderly and frail MM patients the QoL is one of the most important (if not the most important) objective for treatment. Investigators will investigate if the QoL perceived by the patient relates to the frailty assessment and how this varies over time.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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:
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
- Not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frailty status defined according to Geriatric assessment
Time frame: 18 months from Recruitment End
Katz Activity of Daily Living (ADL) Questionnaires with a points scale of 1 or 0, with 0 dependence and 1 independence
Frailty status defined according to biomarkers of frailty: Teleomere Length
Time frame: 18 months from Recruitment End
Biomarkers: Telomere length analysis: on leukocytes and bone marrow by QPCR via the method of Cawthon
Frailty status defined according to biomarkers of frailty: miRNAs
Time frame: 18 months from Recruitment End
Biomarkers:miRNAs expression leukocytes via relative quantitative real-time PCR (qRT-PCR)
Frailty status defined according to biomarkers of frailty: CDKN2A
Time frame: 18 months from Recruitment End
Biomarkers: CDKN2A expression on leukocytes via relative quantitative real-time PCR (qRT-PCR)
Frailty status defined according to Geriatric assessment
Time frame: 18 months from Recruitment End
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
Frailty status defined according to Geriatric assessment
Time frame: 18 months from Recruitment End
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Manchester University NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty status defined according to Geriatric assessment (time frame: 18 months from Recruitment End). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.