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临床试验/NCT00477815
NCT00477815已完成1 期

A Phase I Trial of Zevalin Radioimmunotherapy With High-Dose Melphalan and Stem Cell Transplant for Multiple Myeloma

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年5月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
30
试验地点
1
主要终点
Toxicity as measured by CTCAE v 3.0

研究概览

简要总结

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving monoclonal antibody therapy together with chemotherapy and autologous peripheral stem cell transplant may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab, melphalan, and autologous peripheral stem cell transplant in treating patients with previously treated multiple myeloma.

详细描述

OBJECTIVES:

Primary

  • Determine the safety of rituximab, yttrium Y 90 ibritumomab tiuxetan, high-dose melphalan, and autologous peripheral blood stem cell transplantation in patients with previously treated multiple myeloma.
  • Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonotypic B-cells at baseline and at B-cell recovery in these patients.

Secondary

  • Determine the response rate and progression factors (time to progression, progression-free survival, and duration of response) in patients treated with this regimen.
  • Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonal plasma cells in the blood and marrow prior to high-dose melphalan.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Rituximab + Zevalin

Experimental

Determine the dose level that is both tolerable and achieves the greatest B cell recovery in patients with multiple myeloma.

干预措施: 111In Zevalin (Biological)

Rituximab + Zevalin

Experimental

Determine the dose level that is both tolerable and achieves the greatest B cell recovery in patients with multiple myeloma.

干预措施: rituximab (Biological)

Rituximab + Zevalin

Experimental

Determine the dose level that is both tolerable and achieves the greatest B cell recovery in patients with multiple myeloma.

干预措施: melphalan (Drug)

Rituximab + Zevalin

Experimental

Determine the dose level that is both tolerable and achieves the greatest B cell recovery in patients with multiple myeloma.

干预措施: Stem Cell (Biological)

Rituximab + Zevalin

Experimental

Determine the dose level that is both tolerable and achieves the greatest B cell recovery in patients with multiple myeloma.

干预措施: Sargramostim (GM-CSF) (Biological)

Rituximab + Zevalin

Experimental

Determine the dose level that is both tolerable and achieves the greatest B cell recovery in patients with multiple myeloma.

干预措施: 90Y-Zevalin (Radiation)

结局指标

主要结局

Toxicity as measured by CTCAE v 3.0

时间窗: 19 Months

Clonotypic B cells

时间窗: 19 months

次要结局

  • Impact of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonal plasma cells in the blood and marrow prior to high-dose melphalan(1 week)
  • Response (complete response, very good partial response, partial response)(19 months)
  • Time to progression and duration of response(5 years)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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