Palliative Treatment of Patients With Multiple Myeloma and Painful Vertebral Lesions. A Cross-sectoral Randomized Controlled Trial of Vertebroplasty in Addition to Regular Medical Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Improvement in back-specific disability
研究概览
简要总结
Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).
详细描述
Patients identified by the attending consultant as eligible are invited to participate. Patients who express an interest in participating will be given written and oral information on the purpose, nature and implications of study-participation.
Possible candidates will be identified at the departments of Hematology where the patients are treated for their disease. All Danish departments of Hematology will be invited to participate.
The hematologist will inform the patient of the protocol and decide if they fulfil the inclusion and exclusion criteria. If the patient wishes to participate the hematologist will fill out screening forms regarding disease stage, lines of treatment, current disease status, bisphosphonate status, and pain relief treatment. The hematologist will refer the patient to their collaborating surgical department. The surgical department will decide if the patient has contraindications for surgery and inform the patient of the risk of the procedure.
If the patient decides to participate, he or she will fill out forms regarding ODI, VAS pain score, QoL.
Before randomization, the patients will be divided into two groups, stratifying between patients with known multiple myeloma with new diagnosed spine fracture and relevant pain ≤ 3 months prior to inclusion and patients with newly diagnosed multiple myeloma with new spine fracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •known multiple myeloma
- •verified lesion(s) between Th6-L5
- •4 or less fractures
- •relevant pain in 3 months or less
- •vertebroplasty can be performed in one procedure
- •VAS 5 or more
排除标准
- •presence of neurologic deficit
- •psychological or psychiatric disorder hat is expected to interfere with compliance
结局指标
主要结局
Improvement in back-specific disability
时间窗: 4 weeks post-initiation of treatment
Oswestry Disability Index v2.1 (ODI): Each section is scored on a 0-5 scale, with 5 representing the highest disability.
次要结局
- Improvement in back-specific disability(Up to 12 months post-initiation of treatment)
- General health services(Up to 12 moths post-initiation of treatment)
- Back and leg pain(Up to 12 months post-initiation of treatment)
- Movement, personal care, usual activities, pain/discomfort, depression/anxiety(Up to 12 months post-initiation of treatment)
- Long-term stability of treated vertebra(e)(12 months post-initiation of treatment)