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临床试验/NCT02419118
NCT02419118已完成2 期

"Monoclonal Antibodies for Treatment of Multiple Myeloma. Present Status and Aspects of Effector Mechanisms With Emphasis on the CD38 Antibody Daratumumab "

Vejle Hospital1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
4
试验地点
1
主要终点
Response by IMWG criteria

研究概览

简要总结

Daratumumab is a new treatment for patients with myeloma. While many patients benefit from this treatment some do not and the mechanism(s) of failure are poorly understood. This study aims to clarify aspects of resistance to treatment with daratumumab in order to improve patient outcomes in the future.

详细描述

The effector mechanisms of daratumumab have been extensively studied in vitro, but the in vivo correlates and key determinants of success or failure when daratumumab is used alone or in combination with lenalidomide for treatment of patients with myeloma have not been clarified.

There is potentially a wide spectrum of factors that may influence the quality and duration of response following treatment with daratumumab. The integrity of the patient's immune system may be important. Prior lines of chemotherapy or the myeloma disease itself may impair humural (i.e. complement) or cellular (i.e. ADCC) effector mechanisms that are of importance for the response to daratumumab. Also intrinsic properties of the tumor cells or interactions between myeloma cells and the bone marrow microenvironment could make the myeloma cells refractory to daratumumab.

A better understanding of these variables may enable us to improve the quality and duration of daratumumab-induced responses and make daratumumab-based therapies more effective in the near future.

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

  • Accepted for a clinical trial with Daratumumab for myeloma

排除标准

  • 未提供

研究组 & 干预措施

Dara len dex

Experimental

Daratumumab in combination with lenalidomide and dexamethasone

干预措施: Daratumumab (Drug)

Dara len dex

Experimental

Daratumumab in combination with lenalidomide and dexamethasone

干预措施: Lenalidomide (Drug)

Dara len dex

Experimental

Daratumumab in combination with lenalidomide and dexamethasone

干预措施: Dexamethasone (Drug)

Len dex

Active Comparator

Lenalidomide in combination with dexamethasone

干预措施: Lenalidomide (Drug)

Len dex

Active Comparator

Lenalidomide in combination with dexamethasone

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Response by IMWG criteria

时间窗: 4 weeks

Assessed by M-component in blood and urine samples

次要结局

  • T cell subset numbers(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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