A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
研究概览
简要总结
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.
详细描述
OBJECTIVES:
- Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6.
- Determine the safety and optimal dose of this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays.
OUTLINE: This is a pilot study.
Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1 month later, patients also receive recombinant interleukin-6 SC once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of recurrent multiple myeloma
- •Must have received ≥ 2 prior therapies
- •PATIENT CHARACTERISTICS:
- •Performance status 0-3
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Interleukin-6 and Interferon-α
Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.
干预措施: recombinant interferon-α (Biological)
Interleukin-6 and Interferon-α
Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.
干预措施: recombinant interleukin-6 (Biological)
结局指标
主要结局
Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
时间窗: Up to 5 months
Number of participants with partial or complete response by Bladé criteria where partial response is defined as a \>= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells.
Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events
时间窗: Up to 5 months
Number of participants who discontinued the protocol due to adverse events.
Optimal Dose of Interleukin-6
时间窗: Up to 5 months
Maximum tolerated dose found using a standard 3+3 dose escalation model.
Impact of Treatment on Growth of Myeloma Cells
时间窗: Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study
Percentage change in growth of in vitro myeloma cells from baseline to end of study.
次要结局
未报告次要终点