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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with relapsed/refractory multiple myeloma (RRMM) who have already received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30 | EORTC QLQ-C30 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 | Up to 1 year | 
| 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 | EORTC QLQ-MY20 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-MY20 | Up to 1 year | 
| HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20 |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, HRQoL, Relapsed, Refractory, Outcomes