NCT06160167Completed
Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
Source: ClinicalTrials.gov · Last updated 23 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 4204 (actual)
- First submitted
- 29 Nov 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Multiple myeloma
- NCT number
- NCT06160167
What you commit to
- Study type: Observational
- Participants enrolled: 4204
- From 1 Oct 2023 to the primary completion date, 1 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with less than 6 months of medical data during the prior or follow-up period
- 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
Other
- Exclusion Criteria
- Patients in more than one race category (mix race), missing race, unknown race, and "other" race
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flatiron Health Oncology Database Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.