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Completed

NCT Number: NCT02892383

Quality of Life the Danish Multiple Myeloma Patients

The aim of the project is to improve quality of life for multiple myeloma patients in the future.

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Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sygehus Sønderjylland, Aabenraa, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Description of changes in QoL over time, based on PROM for the general population of multiple myeloma patients.

    Time frame: 24 months

    • 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)

  2. 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

    • 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)

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Danish Myeloma Study Group

Registry information

Official study title

Quality of Life in Danish Multiple Myeloma Patients

Acronym: QoL-MM

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2016
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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