Quality of LifeQoL-MMNCT02892383
Quality of Life the Danish Multiple Myeloma Patients
An observational study of Quality of Life and Multiple Myeloma, run by Odense University Hospital at 10 sites in Denmark.
Trial summary
The aim of the project is to improve quality of life for multiple myeloma patients in the future. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Quality of Life, Multiple Myeloma
- How many people
- 681 participants
- Where
- 10 sitesDenmark
- Study dates
- 27 Feb 2017to 30 Nov 2023
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Danish multiple myeloma patients
Who may be able to join
- Previously untreated or relapsed multiple myeloma patients AND
- Treatment demanding multiple myeloma disease
Who cannot join
- Inability to understand the Danish language or
- Psychic or mental illness that prevents the patient from answering the questions in the questionnaires.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Denmark10 sites
Sygehus Sønderjylland
Aabenraa
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Rigshospitalet
Copenhagen
Sydvestjysk Sygehus
Esbjerg
Herlev Hospital
Herlev
Hospitalsenheden Vest
Holstebro
Odense University Hospital
Odense
Sjællands Universitetshospital
Roskilde
Vejle Sygehus
Vejle
About this study
Official title: Quality of Life in Danish Multiple Myeloma Patients
The aim of the project is to improve quality of life for multiple myeloma patients in the future.
Read the detailed description
Multiple myeloma is an incurable malignancy of the bone marrow and the second most common type of haematological cancer. In Denmark, about 320 patients are diagnosed annually with multiple myeloma, and the cancer often affects older people, but 30 % of the patients living with MM are of working age. The prognosis has improved markedly over the last two decades and is expected to improve further.
Systematic monitoring of symptoms, side effects and complications over time outside clinical trials has not been performed yet. Knowledge of the elderly and frail patients´ perspective on the multiple myeloma disease is lacking, and the time after anti-myeloma treatment is left unstudied. A common side effect (up to 55 %) to specific types of anti-myeloma drugs is peripheral neuropathy (nerve injury), which can be temporary or permanent in the form of long-term sequelae of pain and numbness. Information on this side effect from the patients´ perspective is missing.
The design of the project is a prospective, population-based, national, longitudinal survey with retrospective data collection from more Danish registers. We will include 800 previously untreated and relapsed multiple myeloma patients at treatment-demanding disease recruited from all Danish haematological departments. At inclusion, demographic data and patient-related prognostic markers will be obtained. The patients will complete four validated QoL instruments (EORTC QLQ-C30, MY20, CIPN20 and SF12v2) at 13 measuring points over a period of 24 months. The questions are concerning cancer and MM symptoms, peripheral neuropathy, other side effects, quality of life and functional capacity of a social, emotional and physical character.
This project will provide real-time data collection of the symptoms, side effects, complications and quality of life from the general multiple myeloma patients´ perspective during and after anti-myeloma treatment. It will illuminate the reason for the patients´ high loss of working ability. The findings will be integrated in the future Danish National treatment guidelines, and recommendation for rehabilitation in aspects of shared decision making.
- Conditions
- Quality of Life, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
A longitudinal description of quality of life (QoL) using patient-reported outcomes measurement (PROM) for the general population of multiple myeloma patients.
- Description of changes in QoL over time
Measured: 24 months
Secondary outcomes (3)
Description of changes in QoL over time, based on PROM for the general population of multiple myeloma patients.
- To analyse changes in QoL measured by EORTC QLQ-C30 (score 0-100), EORTC QLQ-MY20 (score 0-100) and SF12v2-4-week recall (score 0-100) in relation to disease characteristics:
- ISS I-III
- Type/-s of anti-myeloma treatment
- Side-effects of treatment measured by EORTC QLQ-MY20 (score 0-100) and EORTC QLQ-CIPN20 (score 0-100)
- Quality of response: IMWG criteria for first and second line treatment
- To analyse changes in QoL measured by EORTC QLQ-C30 (score 0-100), EORTC QLQ-MY20 (score 0-100) and SF12v2-4-week-recall (score 0-100) in relation to patient characteristics:
- Myeloma Frailty score (fit, intermediate-fitness and frail)
- Karnofsky Performance score scale (0-100%)
- Charlson comorbidity Index (0-33) and Freiburger comorbidity index (0-3)
Measured: 24 months
Description of the impact of peripheral neuropathy on QoL in the general population of multiple myeloma patients over time, based on PROM.
- To analyse changes in peripheral neuropathy measured EORTC QLQ-CIPN20 (score 0-100) in relation to
- Type/-s of anti-myeloma treatment
- Side effect of treatment measured by EORTC QLQ-MY20 (score 0-100).
- Quality of response: IMWG criteria for first and second line treatment
- To analyse changes in peripheral neuropathy measured by EORTC QLQ-CIPN20 (score 0-100) in relation to - Myeloma frailty score (fitness, intermediate-fitness and frail)
Measured: 24 months
Description of the impact of recalibration response shift for interpretation of data from longitudinal QoL studies using PROM for QoL measurement in the general population of previously untreated multiple myeloma patients.
Recalibration response shift is a change in the patients internal standard of Measurement and will be measured at a then-test interview 9 months after baseline. Then-test is a retrospective pre-test and will capture recalibration response shift and the true change in QoL. For the pre-test, post-test and then-test the EORTC QLQ-C30 (score 0-100), EORTC QLQ-MY20 (score 0-100), EORTC QLQ-CIPN20 (score 0-100) and SF12v2-4-week recall (score 0-100) will be used.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start27 Feb 2017
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 681 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Myeloma Study Group
- Responsible party
- Principal investigator, Lene Kongsgaard Nielsen, Odense University Hospital
- Investigators
- Lene Kongsgaard Nielsen, MD, Principal investigator, Quality of Life Research Centre, Haematological Department, Odense Univsersity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892383
- Sponsor's protocol ID
- QoL-MM_OUH
- Acronym
- QoL-MM
- Status last verified
- Sep 2024
- First submitted
- 14 Jun 2016
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The cohort will be used as historical controls in clinical intervention trials
Publications
Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.
PubMed 33218965
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Danish Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT02892383
- Acronym / sponsor ID
- QoL-MM / QoL-MM_OUH
- Conditions
- Quality of Life, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 681 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Myeloma Study Group
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
The aim of the project is to improve quality of life for multiple myeloma patients in the future.
Detailed description
Multiple myeloma is an incurable malignancy of the bone marrow and the second most common type of haematological cancer. In Denmark, about 320 patients are diagnosed annually with multiple myeloma, and the cancer often affects older people, but 30 % of the patients living with MM are of working age. The prognosis has improved markedly over the last two decades and is expected to improve further.
Systematic monitoring of symptoms, side effects and complications over time outside clinical trials has not been performed yet. Knowledge of the elderly and frail patients´ perspective on the multiple myeloma disease is lacking, and the time after anti-myeloma treatment is left unstudied. A common side effect (up to 55 %) to specific types of anti-myeloma drugs is peripheral neuropathy (nerve injury), which can be temporary or permanent in the form of long-term sequelae of pain and numbness. Information on this side effect from the patients´ perspective is missing.
The design of the project is a prospective, population-based, national, longitudinal survey with retrospective data collection from more Danish registers. We will include 800 previously untreated and relapsed multiple myeloma patients at treatment-demanding disease recruited from all Danish haematological departments. At inclusion, demographic data and patient-related prognostic markers will be obtained. The patients will complete four validated QoL instruments (EORTC QLQ-C30, MY20, CIPN20 and SF12v2) at 13 measuring points over a period of 24 months. The questions are concerning cancer and MM symptoms, peripheral neuropathy, other side effects, quality of life and functional capacity of a social, emotional and physical character.
This project will provide real-time data collection of the symptoms, side effects, complications and quality of life from the general multiple myeloma patients´ perspective during and after anti-myeloma treatment. It will illuminate the reason for the patients´ high loss of working ability. The findings will be integrated in the future Danish National treatment guidelines, and recommendation for rehabilitation in aspects of shared decision making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Danish multiple myeloma patients
Key inclusion criteria (2 listed)
- Previously untreated or relapsed multiple myeloma patients AND
- Treatment demanding multiple myeloma disease
Key exclusion criteria (2 listed)
- Inability to understand the Danish language or
- Psychic or mental illness that prevents the patient from answering the questions in the questionnaires.
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
A longitudinal description of quality of life (QoL) using patient-reported outcomes measurement (PROM) for the general population of multiple myeloma patients.
Time frame: 24 months
a. Description of changes in QoL over time
3 secondary outcomes
Description of changes in QoL over time, based on PROM for the general population of multiple myeloma patients.
Time frame: 24 months
Description of the impact of peripheral neuropathy on QoL in the general population of multiple myeloma patients over time, based on PROM.
Time frame: 24 months
Description of the impact of recalibration response shift for interpretation of data from longitudinal QoL studies using PROM for QoL measurement in the general population of previously untreated multiple myeloma patients.
Time frame: 9 months
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 23 Sep 2024.
- Derived from this study: PubMed 33218965Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.
- Individual participant dataSharing planned: Yes. The cohort will be used as historical controls in clinical intervention trials
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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.
Lene Kongsgaard Nielsen, MD principal investigator
Quality of Life Research Centre, Haematological Department, Odense Univsersity Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Multiple Myeloma, run by Odense University Hospital at 10 sites in Denmark.
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 2 inclusion and 2 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
A longitudinal description of quality of life (QoL) using patient-reported outcomes measurement (PROM) for the general population of multiple myeloma patients. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02892383, which also lists 1 linked publication.
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 23 Sep 2024.