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

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: No IMiD treatment; Drug: IMiD treatment; Drug: Systemic therapy

• Registration Number: NCT06160167
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Status Verified: 2024-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4204

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with MM not treated with IMiDs	No IMiD treatment	-
Participants with MM treated with IMiDs	IMiD treatment	-
Participants with MM treated with systemic therapy	Systemic therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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).
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).

Trial Locations

Locations (1)

Flatiron Health Oncology Database; 🇺🇸 New York, New York, United States