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Completed

NCT Number: NCT05217082

A Study Assessing the Health-Related Quality of Life (HRQoL) in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure

The purpose of this observational study is to assess HRQoL in relapsed and/or refractory multiple myeloma (RRMM) participants who have previously received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes 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 Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Morrisville, North Carolina, 27560, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have sufficient command of the Japanese language to understand the study instructions and requirements
  • Must be a resident of Japan
  • Must have received prior treatment with:
  • a proteasome inhibitor,
  • an immunomodulatory agent, and
  • an anti-CD38 antibody Subjects must be either 2-4 months, 5-7 months, or 8-11 months post triple class therapy exposure at time of consent
  • Subject must be diagnosed with multiple myeloma

Exclusion criteria

  • Participants enrolled in a clinical trial that includes at least one novel/ experimental agent at the point of questionnaire completion

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

Primary outcomes

  1. Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30

    Time frame: Up to 1 year

    EORTC QLQ-C30 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30

  2. HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30

    Time frame: Up to 1 year

  3. HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30

    Time frame: Up to 1 year

  4. HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30

    Time frame: Up to 1 year

  5. HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30

    Time frame: Up to 1 year

  6. HRQoL in specific domains: Disease Symptoms as measured by the EORTC QLQ-MY20

    Time frame: Up to 1 year

    EORTC QLQ-MY20 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-MY20

  7. HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20

    Time frame: Up to 1 year

Secondary outcomes

  1. HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30

    Time frame: Up to 1 year

  2. HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30

    Time frame: Up to 1 year

  3. HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30

    Time frame: Up to 1 year

  4. HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20

    Time frame: Up to 1 year

  5. HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20

    Time frame: Up to 1 year

  6. HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L

    Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Health-Related Quality of Life (HRQoL) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure in Japan

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
Jun 9, 2023

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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