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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with relapsed/refractory multiple myeloma (RRMM) who have already received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody |
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| 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 |
| 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 | |
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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:
Subject must be diagnosed with multiple myeloma
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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The target population will consist of approximately 50 participants diagnosed with relapsed/refractory multiple myeloma (RRMM) with triple class therapy exposure identified by physicians.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Morrisville | North Carolina | 27560 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| 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 |
| BMS Clinical Trial Patient Recruiting | View source |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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