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

NCT ID: NCT06160167

Last Updated: 2024-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-08-01

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants with MM treated with IMiDs

IMiD treatment

Intervention Type DRUG

Participants with MM treated with IMiDs

Participants with MM not treated with IMiDs

No IMiD treatment

Intervention Type DRUG

Participants with MM not treated with IMiDs

Participants with MM treated with systemic therapy

Systemic therapy

Intervention Type DRUG

Participants with MM treated with systemic therapy

Interventions

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IMiD treatment

Participants with MM treated with IMiDs

Intervention Type DRUG

No IMiD treatment

Participants with MM not treated with IMiDs

Intervention Type DRUG

Systemic therapy

Participants with MM treated with systemic therapy

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers-Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Flatiron Health Oncology Database

New York, New York, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA078-1007

Identifier Type: -

Identifier Source: org_study_id

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