NL-OMON51367招募中2 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis - Aquarius
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Full list of inclusion criteria is found in the protocol section 5.1
- •- >=18 years of age
- •- New diagnosis of systemic AL amyloidosis
- •- Cohort 1: cardiac involvement (AL amyloidosis Mayo Cardiac Stage II and Stage
- •IIIa) with or without other organs involved
- •Cohort 2: one or more organs impacted by systemic AL amyloidosis
- •- ECOG score 0, 1 or 2
- •- Female: negative pregnancy test
- •Cohort 2: racial and ethnic minorities, including Black or African
排除标准
- •Full list of exclusion criteria is found in the protocol section 5.2
- •- Prior therapy for systemic AL amyloidosis or multiple myeloma
- •- Previous or current diagnosis of symptomatic multiple myeloma
- •- Participant received any of the following therapies:
- •a. treatment with an investigational drug or used an invasive investigational
- •medical device within 14 days or at least 5 half-lives, whichever is less.
- •b. vaccinated with an investigational vaccine (except for COVID-19), live
- •attenuated or replicating viral vector vaccines within 4 weeks prior to
- •randomization/enrollment.
- •- Evidence of significant cardiovascular conditions
- •- Participant has an active malignancy other than the disease being treated
- •under study
研究者
相似试验
进行中（未招募）
1 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisEUCTR2021-002639-48-ESJanssen-Cilag International N.V.150
进行中（未招募）
1 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisEUCTR2021-002639-48-NLJanssen-Cilag International N.V.150
进行中（未招募）
1 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisCTIS2023-507069-25-00Janssen - Cilag International190
进行中（未招募）
1 期
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisAmyloid Light Chain AmyloidosisMedDRA version: 23.0Level: LLTClassification code 10083938Term: Amyloid light-chain amyloidosisSystem Organ Class: 100000004870EUCTR2021-002639-48-DEJanssen-Cilag International N.V.150
进行中（未招募）
不适用
A Phase 2 Study of Daratumumab in Combination with Lenalidomide, Bortezomib and Dexamethasone in Elderly Newly Diagnosed Multiple Myeloma Patients eligible for ASCTKCT0006549Samsung Medical Center26