Health-Related Quality of Life (HRQoL) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure in Japan
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30
Time Frame: Up to 1 year
HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30
Time Frame: Up to 1 year
HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30
Time Frame: Up to 1 year
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
HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30
Time Frame: Up to 1 year
HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20
Time Frame: Up to 1 year
Secondary Outcomes
- HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30(Up to 1 year)
- 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: 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)