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OpenTrials
Completed

NCT Number: NCT06160167

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Flatiron Health Oncology Database

New York, 10013, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMiD treatment

Drug

Participants with MM treated with IMiDs

No IMiD treatment

Drug

Participants with MM not treated with IMiDs

Systemic therapy

Drug

Participants with MM treated with systemic therapy

Primary outcomes

  1. Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM

    Time frame: 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 outcomes

  1. Incidence of skin hyperpigmentation in Black, non-Black and all participants who received systemic treatment for MM

    Time frame: 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).

  2. Risk of skin hyperpigmentation in Black and non-Black participants diagnosed with MM and exposed to IMiDs

    Time frame: 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).

  3. Risk of skin hyperpigmentation in non-Black participants exposed to IMiDs versus non-IMiDs for MM

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2023
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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