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临床试验/NCT00633542
NCT00633542已完成3 期

Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for

Università Politecnica delle Marche1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2003年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
103
试验地点
1
主要终点
progression free survival

研究概览

简要总结

This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with multiple myeloma who responded to ThaDD induction therapy

详细描述

Thalidomide has already been used as maintenance and/or consolidation after high-dose therapy followed by autologous stem cell transplantation. Despite a number of phase II and III studies the issues of right dose and duration of thalidomide and subsets of patients benefiting from it have not yet been settled We explored the maintenance therapy after thalidomide, dexamethasone and pegylated liposomal doxorubicin called ThaDD protocol. Patients with de novo or relapsed MM obtaining at least minor response after 4 to 6 ThaDD courses, were randomized to receive standard maintenance therapy with IFN 3 MU 3 times a week or an experimental maintenance therapy such as thalidomide 100 mg per day until relapse or intolerable side effects. Both groups also received pulsed dexamethasone 20 mg 4 days a month.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • patients with newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
  • Written consent

排除标准

  • peripheral neuropathy >= grade 2
  • neutropenia < 1000/mcl or thrombocytopenia < 50000/mcl
  • severe depression
  • organ disfunction > grade 2

研究组 & 干预措施

TD

Experimental

thalidomide-dexamethasone

干预措施: thalidomide (Drug)

ID

Active Comparator

Interferon-dexamethasone

干预措施: interferon alpha (Drug)

结局指标

主要结局

progression free survival

时间窗: 3 years

次要结局

  • overall survival safety(3 years)

研究者

发起方
Università Politecnica delle Marche
申办方类型
Other

研究点 (1)

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