A Study Assessing the Health-Related Quality of Life (HRQoL) in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure
- Conditions
- Multiple Myeloma
- Registration Number
- NCT05217082
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
-
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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30 Up to 1 year HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30 Up to 1 year HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30 Up to 1 year 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
HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30 Up to 1 year HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20 Up to 1 year
- Secondary Outcome Measures
Name Time Method HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30 Up to 1 year HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20 Up to 1 year HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30 Up to 1 year HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L Up to 1 year HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30 Up to 1 year HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20 Up to 1 year
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Morrisville, North Carolina, United States