A Phase II Study of Anakinra (IL-1 Receptor Antagonist) in Patients With Smoldering/Indolent Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone
研究概览
简要总结
RATIONALE: Some cancers need growth factors which are made by the body's white blood cells to keep growing.Anakinra may interfere with the growth factor and stop multiple myeloma from growing. Dexamethasone may stop cancer cells from growing. Giving anakinra together with dexamethasone may be an effective treatment for multiple myeloma.
PURPOSE: This phase II trial is studying how well anakinra works when given with or without dexamethasone in treating patients with smoldering myeloma or indolent multiple myeloma.
详细描述
OBJECTIVES:
Primary
* Determine the response rate in patients with smoldering or indolent multiple myeloma treated with anakinra.
Secondary
- Determine the toxicity of anakinra alone or in combination with dexamethasone in these patients.
- Evaluate the response rate in patients treated with anakinra in combination with dexamethasone.
- Evaluate the proportion of patients who are progression-free at 6 months.
- Determine the tolerability of anakinra in combination with dexamethasone in these patients.
- Determine the time to progression to active multiple myeloma in patients treated with anakinra alone or in combination with dexamethasone.
- Assess the duration of response in these patients.
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 120 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
Anakinra with/without Dexamethasone
Anakinra was given alone for 6 months at which time response was assessed.
If participants achieved a minor response or better they continued on Anakinra alone until disease progression.
If participants achieved stable disease, they added low dose Dexamethasone to Anakinra until progression.
If at any time a participant progresses, they were administered high dose Dexamethasone with Anakinra.
干预措施: Anakinra (IL-1Ra) (Biological)
Anakinra with/without Dexamethasone
Anakinra was given alone for 6 months at which time response was assessed.
If participants achieved a minor response or better they continued on Anakinra alone until disease progression.
If participants achieved stable disease, they added low dose Dexamethasone to Anakinra until progression.
If at any time a participant progresses, they were administered high dose Dexamethasone with Anakinra.
干预措施: Dexamethasone acetate (Drug)
结局指标
主要结局
Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone
时间窗: 6 months
Response Definitions: * Complete Response(CR):disappearance of M-Protein from serum \& urine and immunofixation, \<5% bone marrow(BM) plasma cells \& disappearance of soft tissue plasmacytomas(STP); * Very Good Partial Response(VGPR):\>=90% decrease in serum M-Protein, Urine M-protein \<100 mg/24 hours, \<=5% BM plasma cells, disappearance of STP; * Partial response(PR):\>=50% reduction in serum M-protein, \>=90% decrease in Urine M-protein or \<200 mg/24 hours \& \>=50% decrease in STP; * Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein \& 25-49% decrease in STP
次要结局
- Number of Patients With Response to Treatment With Dexamethasone and Anakinra(During Active treatment (up to 5 years))
- Number of Patients Who Are Progression-free and Alive at 6 Months(at 6 months)
- Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone.(Duration of treatment (up to 5 years))
- Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone(Time from registration to progression or death (up to 5 years))
- Duration of Response(From first documentation of response to progression or last follow-up (up to 5 years))
- Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone(every cycle during treatment (up to 5 years))