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多发性骨髓瘤的综合治疗

2026年9月29日 更新者:Bnai Zion Medical Center

多发性骨髓瘤综合疗法的有效性和安全性

Multiple myeloma is a hematologic malignancy that can cause anemia, renal failure, bone disease, and hypercalcemia. Today, myeloma is considered a chronic disease and most patients will receive ongoing biological treatments. As a result, this disease causes a number of symptoms related to the disease itself or its treatment, which include, among others, weakness and fatigue, bone or nerve pain, depression and anxiety, gastrointestinal symptoms, impairment of sexual function, etc. These symptoms cause significant damage to quality-of-life which is similar in patients who receive different treatment lines. As a result, the FDA emphasized quality-of-life as a key outcome for the approval of new drugs for the disease.

The conventional therapeutic approach to the various symptoms is based on supportive care guidelines including pharmacological and non-pharmacological treatment of pain, gastrointestinal symptoms, psychological components, etc. These treatments involve side effects and usually refer to individual symptoms.

Complementary and integrative medicine includes treatments of touch, movement, mind-body, acupuncture, nutrition and nutritional supplements. Many studies have shown the effectiveness of these treatments on various symptoms in cancer patients including pain, depression and anxiety, fatigue and weakness, gastrointestinal symptoms, etc. In myeloma patients, the effect of diet and nutritional supplements was mainly examined, but there is also little information on the effectiveness of mind-body treatments on symptoms of anxiety and depression, as well as acupuncture on neuropathy or on symptoms experienced by myeloma patients around autologous bone marrow transplantation.

In recent years, a wide variety of new drugs have entered the market that cause side effects that were unknown until now and little is known about the effect of complementary medicine treatments on symptoms and quality-of-life of myeloma patients since the development of these drugs.

In this study we will examine the effect of complementary and integrative medicine treatments (including acupuncture, touch, movement, mind-body) on the quality-of-life and symptoms that characterize myeloma patients during treatment with different lines of therapy, including new drugs.

Patients with a diagnosis of multiple myeloma who meet the study's inclusion criteria will be divided into the intervention group (complementary medicine treatments) and the control group (no treatments) according to their preferences. All the patients of the intervention group and the patients of the control group who agree will be asked to fill out quality-of-life questionnaires validated and translated into Hebrew, Arabic and Russian before the start of the treatment. The questionnaires include European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) which is a general quality-of-life questionnaire for cancer patients, with the addition of MY20 which is an addition of 20 specific questions for patients with multiple myeloma, the Edmonton Symptom Assessment System (ESAS) questionnaire which examines the severity of 10 common symptoms in patients with malignant disease, and the EuroQol-5 Dimension (EQ-5D) questionnaire which examines quality-of-life in cancer patients and is used as a primary outcome in many clinical studies. The same questionnaires will be sent again 1-2 weeks after the end of the treatments in the intervention group and 6-8 weeks after recruitment in the control group. Socio-demographic and medical data will also be collected from the patients and their medical records.

研究概览

地位

招聘中

研究类型

介入性

注册 (估计的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Haifa、以色列、3339419
        • 招聘中
        • Bnai Zion Medical Center
        • 接触:
        • 首席研究员:
          • Ilana Levy Yurkovski, MD
        • 副研究员:
          • Ohad Cohen-Naznin

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age over 18
  • Diagnosis of multiple myeloma
  • Possibility to answer questionnaires once a month in Hebrew, Arabic or Russian
  • Signing an informed consent form

Exclusion Criteria:

  • Age under 18 years
  • In patients who will receive acupuncture: platelet level below 20x10^9/L
  • In patients who will receive reflexology: deep vein thrombosis in the leg
  • Hemodynamic instability
  • Psychiatric disorder impairing competence

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:控制
实验性的:Integrative medicine

Integrative medicine treatments including acupuncture, touch, movement, mind-body, as patient's and staff's choice

Integrative medicine treatments including acupuncture, touch, movement, mind-body, as patient's and staff's choice

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Quality-of-life specific to myeloma patients
大体时间:From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

EORTC QLQ-MY2 (European Organization for the Research and Treatment of Cancer Quality of Life for Myeloma patients) score at 1-2 weeks after end-of-treatment in intervention group and 7-8 weeks after recruitment in control group. It comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment, Future Perspective, and Body Image. Domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.

From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

次要结果测量

结果测量
措施说明
大体时间
General quality-of-life evaluation
大体时间:From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

European Organization Research for Treatment of cancer core quality of life (EORTC-QLQ-C30) questionnaire summary score which is calculated from the mean of 13 of the 15 quality-of-life (QLQ-C30) scales of the questionnaire = (Physical Functioning+ Role Functioning+ Social Functioning+ Emotional Functioning+ Cognitive Functioning+ 100-Fatigue+ 100-Pain+ 100-Nausea_Vomiting+ 100-Dyspnoea+ 100-Sleeping Disturbances+ 100-Appetite Loss+ 100-Constipation+ 100-Diarrhoea)/13. Scores range from minimum 0 to maximum 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group
Symptom relief
大体时间:From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

Edmonton Symptom Assessment System (ESAS): assesses the severity over time of nine symptoms common among patients with cancer and other advanced illness: pain, tiredness, drowsiness, nausea, shortness of breath, appetite, depression, anxiety, and wellbeing. A higher score represents a higher ("worse") level of symptoms.

From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group
Compliance to conventional therapy
大体时间:From enrollment to 1 year after enrollment

Relative dose intensity (RDI) which is the ratio of delivered dose intensity (DDI) of myeloma treatment with standard dose intensity (SDI) of myeloma treatment = DDI/SDI

From enrollment to 1 year after enrollment
Economic analysis
大体时间:From enrollment to 3 months after enrollment

Calculation of quality-adjusted life years based on EuroQol-5 Dimension (EQ-5D) scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient indicates health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

From enrollment to 3 months after enrollment
Overall response rate (ORR) to myeloma treatment
大体时间:From enrollment to 1 year after enrollment

Percentage of patients who have a partial response or complete response to the treatment of myeloma

From enrollment to 1 year after enrollment
Progression-free survival (PFS)
大体时间:From enrollment to 2 years after enrollment

The length of time during and after the treatment of myeloma that patient lives and disease does not progress

From enrollment to 2 years after enrollment
Overall survival (OS)
大体时间:From enrollment to 2 years after enrollment

The length of time during and after the treatment of myeloma that patient lives

From enrollment to 2 years after enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ilana Levy Yurkovski, MD、Bnai Zion Medical Center, Haifa, Israel

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月15日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2024年7月15日

首先提交符合 QC 标准的

2024年7月17日

首次发布 (实际的)

2024年7月23日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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