NCT04221178进行中（未招募）不适用
A Single-Arm, Prospective Study of Maintenance Therapy Cessation for Patients With Multiple Myeloma in Sustained MRD-Negative Remissions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study will test whether stopping maintenance therapy in people with multiple myeloma in MRD-negative remission has the same effect on disease control as continuing this therapy. The study will look at whether people currently on maintenance therapy can safely stop this treatment and continue with active surveillance instead while keeping their MRD-negative remission status for at least 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with plasma cell myeloma treated with any number of prior lines of therapy, who at the time of study enrollment have had sustained MRD-negativity at a given timepoint and a subsequent time point with an interval of 3 or more years while on continuous maintenance therapy. MRD-negativity is defined per the International Myeloma Working Group Consensus Panel.
- •MRD positivity will be defined by detection of 1 or more neoplastic plasma cells in 10^5 nucleated cells by flow cytometry as per IMWG criteria (i.e., sensitivity of 10-5)
- •Age >/= 18 years with ECOG performance status </= 2
- •Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care
排除标准
- •Patients found to be MRD-positive at time of screening
- •Patients with plasma cell leukemia or other disorder of plasma cell neoplasm
- •Patient who are receiving other therapy with the intent of treating myeloma with the exception of bisphosphonates
- •Patients being treated for another, potentially life-limiting malignancy with 3-year lead-in to study enrollment, with the exception of non-melanoma skin cancer or in situ malignancy or malignancies that have received definitive curative therapy
- •Prior organ transplant or condition requiring immunosuppressive therapy
- •Prior allogeneic hematopoietic cell transplant
- •Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or IV heart failure, uncontrolled coronary artery disease/arrhythmia, psychiatric or social disorder that would compromise compliance with the study schema
研究组 & 干预措施
MRD-Negative Participants
干预措施: Cessation of continuous matinenace therapy (Other)
结局指标
主要结局
Progression Free Survival
时间窗: 1 year
Maintaining a MRD-negative state for one year of enrolling on this study
次要结局
未报告次要终点
研究者
研究点 (14)
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