A Phase II Trial of IPH2101 (Anti-KIR) in Smoldering Multiple Myeloma (SMM)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
Background:
- Recent studies have shown that smoldering multiple myeloma has a high risk of progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5 years of diagnosis. People with smoldering multiple myeloma have abnormal blood test results that show a high level of monoclonal protein (M-protein) in the blood and of plasma cells in the bone marrow. There are currently no known effective treatments to prevent smoldering multiple myeloma from developing into multiple myeloma, and there are no known tests for determining whether an individual with smoldering multiple myeloma will develop multiple myeloma.
- Certain cells in the immune system, known as natural killer (NK) cells, are active against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells. Researchers are interested in determining whether anti-KIR can be given to individuals with smoldering multiple myeloma to improve their abnormal blood test results.
Objectives:
- To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood test results related to smoldering multiple myeloma.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with smoldering multiple myeloma.
Design:
- Participants will be screened with a physical examination and medical history, and will provide baseline blood, urine, and bone marrow samples before beginning the study drug.
- Participants will receive anti-KIR intravenously for 1 hour, and will be closely monitored for 24 hours after receiving the first dose. If there are no serious side effects, participants will receive five additional anti-KIR doses, one every other month, for a total of six treatment cycles.
- Participants will have monthly visits to provide additional blood and urine samples, and may have additional bone marrow biopsies as directed by the study researchers.
- Participants will have followup visits every 3 to 6 months for up to 5 years after receiving anti-KIR treatment.
详细描述
Background:
- Multiple myeloma (MM) is an incurable plasma cell neoplasm with a median survival of 3-4 years.
- Smoldering multiple myeloma (SMM) is a premalignant plasma cell disorder characterized by monoclonal protein greater than or equal to 3 g/dL or bone marrow plasma cells greater than or equal to 10 percent in the absence of myeloma-related tissue impairment with 51 percent progression to MM at 5 years.
- Current recommendations do not endorse treatment of SMM with chemotherapy.
- Transplanted Natural Killer (NK) Cells have anti-myeloma activity.
- Anti-KIR (IPH2101) is a monoclonal antibody that facilitates NK cell mediated killing of myeloma cells by blocking inhibitory receptors (KIR) on NK cells.
Objectives:
- To assess the response rate of anti-KIR(IPH2101) in patients with SMM
- To evaluate the toxicity of anti-KIR(IPH2101) in patients with SMM
- To evaluate the pharmacokinetic parameters and biological activity of anti-KIR (IPH2101)
Eligibility:
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 —（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
anti-KIR in Smoldering Multiple Myeloma Patients
Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
干预措施: (Anti-KIR) (Drug)
结局指标
主要结局
Response Rate
时间窗: 1 year
Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR \>25% and \<50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium \>2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin \<10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.
次要结局
- Count of Participants With Serious and Non-Serious Adverse Events(Date treatment consent signed to date off study, approximately 3 years and 5 months)
研究者
Dickran Kazandjian, M.D.
Principal Investigator
National Cancer Institute (NCI)