Multiple Myeloma
Conditions
Brief summary
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.
Interventions
DRUGIMiD treatment
Participants with MM treated with IMiDs
DRUGNo IMiD treatment
Participants with MM not treated with IMiDs
DRUGSystemic therapy
Participants with MM treated with systemic therapy
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of skin hyperpigmentation in Black, non-Black and all participants who received systemic treatment for MM | 12 months | 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). |
| Risk of skin hyperpigmentation in Black and non-Black participants diagnosed with MM and exposed to IMiDs | 12 months | 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). |
| Risk of skin hyperpigmentation in non-Black participants exposed to IMiDs versus non-IMiDs for MM | 12 months | 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). |
Countries
United States
Outcome results
None listed