NCT06160167已完成不适用
Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 4,204 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,204
- 试验地点
- 1
- 主要终点
- Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Participants with MM treated with IMiDs
干预措施: IMiD treatment (Drug)
Participants with MM not treated with IMiDs
干预措施: No IMiD treatment (Drug)
Participants with MM treated with systemic therapy
干预措施: Systemic therapy (Drug)
结局指标
主要结局
Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM
时间窗: 12 months
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).
次要结局
- Incidence of skin hyperpigmentation in Black, non-Black and all participants who received systemic treatment for MM(12 months)
- Risk of skin hyperpigmentation in non-Black participants exposed to IMiDs versus non-IMiDs for MM(12 months)
- Risk of skin hyperpigmentation in Black and non-Black participants diagnosed with MM and exposed to IMiDs(12 months)
研究者
研究点 (1)
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