An observational study in Quality of Life and Multiple Myeloma, sponsored by Odense University Hospital. Completed at 10 sites in Denmark. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Odense University Hospital · Observational
The aim of the project is to improve quality of life for multiple myeloma patients in the future.
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.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 681 is above the median of 145 across 482 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Odense University Hospital is the lead sponsor of 477 studies on the registry; 109 are open to participants now.
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Danish multiple myeloma patients
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Exclusion Criteria:
A longitudinal description of quality of life (QoL) using patient-reported outcomes measurement (PROM) for the general population of multiple myeloma patients.
a. Description of changes in QoL over time
Time frame: 24 months
Description of changes in QoL over time, based on PROM for the general population of multiple myeloma patients.
1. 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 2. 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)
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.
1. 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 2. 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)
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.
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.
Time frame: 9 months
Plan to share: Yes — The cohort will be used as historical controls in clinical intervention trials
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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