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NCT Number: NCT07642362

Digital Support for Multiple Myeloma Quality of Life

The objective of this prospective study is to investigate the quality of life of patients with multiple myeloma and the effectiveness of support provided through a personalized web-based platform.

Specifically, the study will compare Patient-Reported Outcomes (PROs) and the associated improvement in side effects and quality of life achieved through appropriate personalized educational and supportive content.

Recruiting

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Patient Reported Outcome (PRO) Quality of Life Supportive Care in Cancer Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandra General Hospital

Athens, 11528, Greece

Location status: Recruiting

Location contact

Professor Evangelos Terpos

CONTACT

[email protected]

+302132162846

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with newly diagnosed or relapsed/refractory multiple myeloma
  • Patients that are able to use the digital platform/application

Exclusion criteria

  • Patients that are not able to use the digital platform/application

Treatment and study plan

Digital support

Behavioral

Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.

Primary outcomes

  1. Patient Reported Outcomes (PROs)

    Time frame: From enrollment, until study completion, average 1 year.

    Patient-Reported Outcomes (PROs) consisting of treatment related side-effects that patients themselves report on the online platform. The reported side-effects will be evaluated throughout the entire duration of the study.

    17 side-effects will be captured (each measured as either present or absent) throughout the study:

    • Ocular toxicity
    • Fatigue
    • Diarrhea
    • Constipation
    • Neuropathy
    • Dermatological toxicity
    • Dyspnoea
    • Insomnia
    • Nausea
    • Vomiting
    • Dry mouth
    • Nail problems
    • Memory problems
    • Hypertension
    • Lower extremity oedema
    • Sexual dysfunction
    • Bone pain

    Only data from patients who report at least 2 times will be eligible for outcome analysis.

    The following calculation and evaluation will be conducted:

    For each of the two Arms, the percentage of patients who at the final side-effect data collection reported fewer than 50% of the specific side-effects they had reported at previous side-effect data collection timepoints.

Secondary outcomes

  1. Progression-Free Survival

    Time frame: At 12 months from each patient's enrollment

    Progression-free survival: Laboratory-confirmed disease progression or death, measured from study entry

  2. Overall Survival

    Time frame: At 12 months from each patient's enrollment

    Overall survival: Time to death, measured from study entry

Sponsors and collaborators

Lead sponsor

CareAcross

Industry

Collaborators

  • Μedical Association for the Study of Cancer Biology and Treatments (Μ.Α.S.CA.B.T.)

Registry information

Official study title

Digital Support for Enhancing the Quality of Life of Patients With Multiple Myeloma: An Observational, Randomized, Prospective Study (DigiMyQoL)

Acronym: DigiMyQoL

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

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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