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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: IMiD treatment; Drug: No IMiD treatment; Drug: Systemic therapy

• Study Type: Observational
• Enrollment (Actual): 4204

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Flatiron Health Oncology Database

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Black and non-Black participants with MM

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with MM treated with IMiDs	Drug: IMiD treatment; Participants with MM treated with IMiDs
Participants with MM not treated with IMiDs	Drug: No IMiD treatment; Participants with MM not treated with IMiDs
Participants with MM treated with systemic therapy	Drug: Systemic therapy; Participants with MM treated with systemic therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol Myers-Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Pigmentation Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Hyperpigmentation
• Other Study ID Numbers: CA078-1007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No