A Phase II Randomized Study of the Efficacy of Curcumin for Reducing Symptoms During Maintenance Therapy in Multiple Myeloma Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- AUC from 3 months Post-Transplantation to 9 months Post-Transplantation
研究概览
简要总结
The goal of this clinical research study is to learn if curcumin can reduce the symptoms reported by patients with multiple myeloma (MM) who receive treatment with lenalidomide.
详细描述
Curcumin is the active ingredient in the spice turmeric. It may interfere with the production of cytokines (which cause inflammation), which may help reduce multiple symptoms.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take curcumin. Group 2 will take a placebo. You will have an equal chance of being assigned to each group. No matter which group you are in, you will be given standard care by your treating doctor.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Must have a histologically confirmed diagnosis of multiple myeloma.
- •Must be >/= 18 years of age.
- •Must have a performance status (ECOG PS) of 0-
- •Must be qualified and have signed consent to receive lenalidomide for maintenance therapy for MM.
- •Must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.
- •Must also agree to refrain from use of self prescribed curcumin during the course of the study.
- •Must have negative pregnancy test before signing consent for MM therapy.
排除标准
- •Unable to understand the symptom assessment or not willing to participate in the study.
- •Treatment for other carcinomas within the last 5 years, except for cured non-melanoma skin and treated in-situ cervical cancer.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or requiring IV antibiotics, cardiac disease (NYHA class III or IV heart failure), unstable angina pectoris, unstable cardiac arrhythmia or tachycardia, or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
- •Concurrent use of coumadin other than low dose (1 mg) coumadin used for line patency.
- •Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox.
- •Sorivudine and brivudine use within 4 weeks of the start of study treatment.
- •Gastric or duodenal ulcers, or gastric hyperacidity disorders.
- •Currently receiving anticoagulants (heparin) or antiplatelets (clopidogrel, ticlopidine, aspirin/dipyridamole)
- •INR > 1.5 (upper limit of normal = 1.5).
- •History of deep vein thrombosis.
- •Received allogeneic transplant.
- •Allergy to turmeric, Curcumin, or yellow dye.
- •Bowel or bile duct obstruction.
研究组 & 干预措施
Curcumin
1000 mg/day Curcumin + 5 -15 mg/day Lenalidomide
干预措施: Curcumin (Drug)
Placebo
Placebo daily + 5 -15 mg/day Lenalidomide
干预措施: Placebo (Other)
结局指标
主要结局
AUC from 3 months Post-Transplantation to 9 months Post-Transplantation
时间窗: Assessments within +/-3 days of 4 week cycle start date for 6 cycles.
Daily area under the curve (AUC) where AUC is based on average of 5 most severe symptoms (pain, fatigue, bone aches, numbness, disturbed sleep) being experienced by MM patients as measured by MDASI-MM, a multiple-symptom measure of cancer-related symptoms rate severity of physical, affective, and cognitive symptoms on 0-10 numeric scales, ranging from 0 "not present" to 10 "as bad as you can imagine."
次要结局
未报告次要终点