Clinical trial · Observational
Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
NCT06160167CI-TRIAL-00080114completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMiD treatment | Drug | — | UNRESOLVED |
| No IMiD treatment | Drug | — | UNRESOLVED |
| Systemic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Participants with MM treated with IMiDs
- interventionNames
- Drug: IMiD treatment
- label
- Participants with MM not treated with IMiDs
- interventionNames
- Drug: No IMiD treatment
- label
- Participants with MM treated with systemic therapy
- interventionNames
- Drug: Systemic therapy
Primary outcomes (1)
- measure
- Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.