Clinical trial NCT02892383: Quality of Life the Danish Multiple Myeloma Patients
Official title: Quality of Life in Danish Multiple Myeloma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Multiple Myeloma
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Myeloma Study Group
First posted: 2016-09-08
Enrollment: 681
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish multiple myeloma patients

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Previously untreated or relapsed multiple myeloma patients AND
* Treatment demanding multiple myeloma disease

Exclusion Criteria:

* Inability to understand the Danish language or
* Psychic or mental illness that prevents the patient from answering the questions in the questionnaires.

Primary outcomes:
measure: A longitudinal description of quality of life (QoL) using patient-reported outcomes measurement (PROM) for the general population of multiple myeloma patients.
timeFrame: 24 months
Secondary outcomes:
measure: Description of changes in QoL over time, based on PROM for the general population of multiple myeloma patients.
timeFrame: 24 months
measure: Description of the impact of peripheral neuropathy on QoL in the general population of multiple myeloma patients over time, based on PROM.
timeFrame: 24 months
measure: 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.
timeFrame: 9 months
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Sønderjylland
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Holstebro
country: Denmark
facility: Hospitalsenheden Vest
city: København
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital
city: Vejle
country: Denmark
facility: Vejle Sygehus
Study officials:
affiliation: Quality of Life Research Centre, Haematological Department, Odense Univsersity Hospital
name: Lene Kongsgaard Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.