Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, HRQoL, Relapsed, Refractory, Outcomes
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20 | Up to 1 year | — |
| 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: Physical Functioning 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 |
Secondary
| Measure | Time frame |
|---|---|
| HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30 | 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 |
| 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: Functional Scale as measured by the EORTC QLQ-C30 | Up to 1 year |
Countries
United States
Outcome results
None listed