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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Multiple Myeloma

Treatments: Drug: No IMiD treatment; Drug: IMiD treatment; Drug: Systemic therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT06160167

CA078-1007

Details and patient eligibility

About

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.

Enrollment: 4,204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,204 participants in 3 patient groups

Participants with MM treated with IMiDs

Treatment:

Drug: IMiD treatment

Participants with MM not treated with IMiDs

Treatment:

Drug: No IMiD treatment

Participants with MM treated with systemic therapy

Treatment:

Drug: Systemic therapy