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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06160167
• Other study ID #: CA078-1007
• Status: Active, not recruiting
• Start date: October 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12378
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperpigmentation
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• IMiD treatment
Participants with MM treated with IMiDs
• No IMiD treatment
Participants with MM not treated with IMiDs
• Systemic therapy
Participants with MM treated with systemic therapy

Locations

Country	Name	City	State
United States	Flatiron Health Oncology Database	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls