Role of Osteocytes in Myeloma Bone Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Molecular interactions between multiple myeloma and osteocytes
研究概览
简要总结
Progress in the treatment of myeloma and myeloma bone disease has substantially increased overall survival, but relapse is inevitable and better treatment is needed. The bone microenvironment is tremendously complex, so that targeting single interactions between tumor and bone is unlikely to be effective. Treatments need to block centrally important, multifunctional pathways. The investigators data point to a central role of the osteocyte to induce heparanase, a multifunctional mediator of myeloma bone disease. Increased heparanase due to FGF23 may make systemic inhibitors of heparanase less effective in bone than elsewhere. FGF23 neutralizing antibodies have been developed for non-cancer conditions of FGF23 excess, such as chronic kidney disease (Shimada & Fukamoto, 2012), and could be used in MM alone or in combination with heparanase inhibitors. Complete neutralization of FGF23 has adverse effects, but neutralization of FGF23 excess may be practical, or in the future, suppression of excess FGF23 biosynthesis by osteocytes.
The investigators hope to determine serum FGF23 and heparanase, Dkk1 and plasma klotho levels in patients with newly diagnosed and relapsed myeloma compared to healthy controls with this exploratory study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years but ≤ 95 years at the time of consent
- •Subjects must be English-speaking
- •Must voluntarily sign the most current informed consent and HIPAA documents prior to study participation.
- •Have no prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers can also be enrolled as healthy volunteers.
- •Have no known liver or kidney disorders
排除标准
- •Pregnant females will be excluded from the study.
- •Subjects allergic to xylocaine will be excluded.
- •Subjects with an acute illness (Ex. upper respiratory infection, viral illness) in the past seven days will be excluded.
- •History of bleeding disorders.
- •Subjects deemed incompetent by treating physician
- •Institutionalized, mentally disabled subjects
- •Subjects who are prisoners
结局指标
主要结局
Molecular interactions between multiple myeloma and osteocytes
时间窗: Up to 4 years
To determine FGF23 and heparanase, Dkk1 and plasma klotho levels increase in patients with newly diagnosed and relapsed myeloma compared to healthy controls.
次要结局
- Multiple Myeloma osteocytes and Type I collagen fragments on bone resorption(Up to 4 years)
- Multiple Myeloma osteocytes and tumor staging(Up to 4 years)
研究者
Attaya Suvannasankha
Assistant Professor of Clinical Medicine
Indiana University School of Medicine