Lenalidomide Maintenance Therapy in Multiple Myeloma: A Phase II Clinical and Biomarker Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts
研究概览
简要总结
Background:
- Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed at controlling symptoms and reducing the number of myeloma cells. It continues until the cancer stops responding to treatment. At that time, treatment may switch to maintenance therapy, which is given to try to extend the response of the first therapy for as long as possible. Research suggests that lenalidomide maintenance therapy may delay the time for myeloma cells to start to grow and possibly improve survival.
- Lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Researchers want to look at the long-term effect of lenalidomide on immune cells. It will also look at the effects of extended treatment on the cancer and the immune system.
Objectives:
- To test the long-term effectiveness of lenalidomide therapy for multiple myeloma.
Eligibility:
- Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine sample will be collected. A bone scan and bone marrow biopsy will also be performed.
- Participants will receive lenalidomide maintenance treatment. It will be given according to the standard of care for multiple myeloma. Participants will take lenalidomide every day for 21 days of repeated 28-day cycles.
- Treatment will be monitored with frequent blood tests. Blood tests will look at the effect of the treatment on the immune system.
- Treatment will continue as long as the cancer does not worsen and the side effects are not severe.
详细描述
Background:
Multiple myeloma (MM) remains largely an incurable disease with an estimated median survival of 6-7 years in standard risk myeloma and 2-3 years in high risk disease despite treatment with autologous stem cell transplantation (ASCT).
Maintenance therapy to achieve sustained suppression of residual disease following chemotherapy or ASCT has long been viewed as a desirable approach for extending survival in MM.
Giving the immunomodulatory drug lenalidomide after induction or re-induction treatment may stimulate the immune system in various ways to stop or slow the return of cancer.
It is not yet known how immune stimulatory effects of extended dosing with lenalidomide in the maintenance setting correlate with clinical benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lenalidomide Maintenance Therapy for Multiple Myeloma
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts
时间窗: participants were followed for the duration of their treatment, an average of 2 years
Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.
次要结局
- Number of Participants With Serious and Non-serious Adverse Events(37 months and 12 days)
- Duration of Response(participants were followed for the duration of their treatment, an average of 2 years)
- Progression Free Survival (PFS)(participants were followed for the duration of their treatment, an average of 2 years)
- Changes in B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy(participants were followed for the duration of their treatment, an average of 2 years)
- Expression of Cereblon (CRBN) and How it Relates to Natural Killer (NK) Cell Number and Activity(participants were followed for the duration of their treatment, an average of 2 years)
- Natural Killer (NK) Cell Function and Activity(participants were followed for the duration of their treatment, an average of 2 years)
研究者
Dickran Kazandjian, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)