Clinical trial NCT06160167: Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
Official title: Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 4204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Black and non-Black participants with MM

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of skin hyperpigmentation in Black, non-Black and all participants who received systemic treatment for MM
timeFrame: 12 months
measure: Risk of skin hyperpigmentation in Black and non-Black participants diagnosed with MM and exposed to IMiDs
timeFrame: 12 months
measure: Risk of skin hyperpigmentation in non-Black participants exposed to IMiDs versus non-IMiDs for MM
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Flatiron Health Oncology Database
state: New York
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers-Squibb
role: STUDY_DIRECTOR
References: