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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05217082
Collaborator
(none)
50
Enrollment
1
Location
6.2
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Health-Related Quality of Life (HRQoL) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure in Japan
    Actual Study Start Date :
    Feb 22, 2022
    Anticipated Primary Completion Date :
    Aug 31, 2022
    Anticipated Study Completion Date :
    Aug 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1

    Participants with relapsed/refractory multiple myeloma (RRMM) who have already received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody

    Outcome Measures

    Primary Outcome Measures

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

    3. HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30 [Up to 1 year]

    4. HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30 [Up to 1 year]

    5. HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30 [Up to 1 year]

    6. HRQoL in specific domains: Disease Symptoms as measured by the EORTC QLQ-MY20 [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 [Up to 1 year]

    Secondary Outcome Measures

    1. HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30 [Up to 1 year]

    2. HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30 [Up to 1 year]

    3. HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30 [Up to 1 year]

    4. HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20 [Up to 1 year]

    5. HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20 [Up to 1 year]

    6. HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L [Up to 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. a proteasome inhibitor,

    2. an immunomodulatory agent, and

    3. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Morrisville North Carolina United States 27560

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05217082
    Other Study ID Numbers:
    • CA089-013
    First Posted:
    Feb 1, 2022
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Multiple Myeloma
    HRQoL
    Relapsed
    Refractory
    Outcomes
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of May 18, 2022