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

NCT06160167 | Completed FDA Drug

• 1 other identifier: CA078-1007
• Study Type: observational
• Target: 4,204
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  12 months

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

  12 months

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

  12 months

Study Arms (3)

Participants with MM treated with IMiDs

Drug: IMiD treatment

Participants with MM not treated with IMiDs

Drug: No IMiD treatment

Participants with MM treated with systemic therapy

Drug: Systemic therapy

Interventions

IMiD treatment DRUG

Participants with MM treated with IMiDs

Participants with MM treated with IMiDs

No IMiD treatment DRUG

Participants with MM not treated with IMiDs

Participants with MM not treated with IMiDs

Systemic therapy DRUG

Participants with MM treated with systemic therapy

Participants with MM treated with systemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Black and non-Black participants with MM

You may qualify if:

• 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

You may not qualify if:

• 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
• Dyschromia, unspecified
• Other dyschromia
• L81.0 Post inflammatory hyperpigmentation
• L81.1 Chloasma/melasma
• L81.4 Other melanin hyperpigmentation
• L81.8 Other specified disorders of pigmentation

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Flatiron Health Oncology Database

New York, New York, 10013, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol Myers-Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: October 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)