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The purpose of this study is to measure the incidence of hyperpigmentation in Black participants with multiple myeloma (MM) treated with immunomodulatory drugs (IMiDs) compared with Black participants with MM not treated with IMiDs. The study will use de-identified data from electronic medical records in the Flatiron Health database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with MM treated with IMiDs |
| ||
| Participants with MM not treated with IMiDs |
| ||
| Participants with MM treated with systemic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMiD treatment | Drug | Participants with MM treated with IMiDs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM | Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of skin hyperpigmentation in Black, non-Black and all participants who received systemic treatment for MM | Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period). | 12 months |
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Inclusion Criteria:
Participants ≥18 years of age at index date
Participants with new diagnosis of MM as defined by:
Participants who received at least one systemic MM therapy on or after initial MM diagnosis
Participants who did not receive clinical study drug at any time during the observation period
Participants with race information
Exclusion Criteria:
Exclusion Criteria
Patients with less than 6 months of medical data during the prior or follow-up period
Patients in more than one race category (mix race), missing race, unknown race, and "other" race
Patients diagnosed with the following hematological cancers on or prior to the index date:
Patients with evidence of skin hyperpigmentation (ICD-9: 709.00, 709.09; ICD-10: L81.0, L81.1, L81.4, L81.8) on or prior to the index date
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Black and non-Black participants with MM
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers-Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flatiron Health Oncology Database | New York | New York | 10013 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| No IMiD treatment |
| Drug |
Participants with MM not treated with IMiDs |
|
| Systemic therapy | Drug | Participants with MM treated with systemic therapy |
|
| Risk of skin hyperpigmentation in Black and non-Black participants diagnosed with MM and exposed to IMiDs | Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period). | 12 months |
| Risk of skin hyperpigmentation in non-Black participants exposed to IMiDs versus non-IMiDs for MM | Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period). | 12 months |
| 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 |