Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs

Study Overview
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Brief Summary
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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.

Official Title
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Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: IMiD treatment
* Drug: No IMiD treatment
* Drug: Systemic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants ≥18 years of age at index date Participants with new diagnosis of MM as defined by: ICD-9-CM: 203.0x and/or ICD-10-CM: C90.0x or C90 during the study period At least two documented clinical visits for MM on different days and occurring on or after January 1, 2011 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: myelodysplastic syndromes (ICD-9: 238.74, 238.75; ICD-10: D46.xx) mantle cell lymphoma (ICD-9: 200.4x, ICD-10: C83.1x) follicular lymphoma (ICD-9: 202.0x, ICD-10: C82.xx) marginal zone lymphoma (ICD-9: 200.3x, ICD-10: C83.4x) 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 709.00 Dyschromia, unspecified 709.09 Other dyschromia L81.0 Post inflammatory hyperpigmentation L81.1 Chloasma/melasma L81.4 Other melanin hyperpigmentation L81.8 Other specified disorders of pigmentation

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Participants with MM treated with IMiDs<br> | Drug: IMiD treatment<br>* Participants with MM treated with IMiDs<br>|
| Participants with MM not treated with IMiDs<br> | Drug: No IMiD treatment<br>* Participants with MM not treated with IMiDs<br>|
| Participants with MM treated with systemic therapy<br> | Drug: Systemic therapy<br>* Participants with MM treated with systemic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |