Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients, a Phase I/II, Multiple Center, Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, in the phase II trial, the safety and efficacy of chidamide+VRD will be compared with that of VRD regimen.
详细描述
In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, which will be determined by efficacy and safety profiles of the patients; afterward, the optimal dosage of chidamide will be combined with VRD regimen, patients will be randomly assigned to chidamide+VRD group or VRD group, and their efficacy and safety will be compared.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Diagnosed as multiple myeloma, and has one of the above:
- •high risk karyotype, such as 17p-，t（4；14），t（14；16），t（14；20）或 1q gain,1p-, double hit myeloma, triple hit myeloma, etc;
- •IgD/IgE MM;
- •with measurable extra-medullary plasmacytoma;
- •flowcytometry showed peripheral blood plasma cell ≥0.165%；
- •2.Secretory MM should have measurable markers, including:
- •specific M protein value (≥5g/L)；
- •and/or involved flc ≥100mg/L；
- •and/or measurable extramedullary foci (diameter>1cm on CT);
- •3.Age≥18 years, male or female;
- •4.ECOG 0-2 points, with life expectance ≥3 months; GA score <2;
- •5.ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of normal maximum；
- •6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L;
- •7.eGFR≥40ml/min，except in the case of myeloma-related nephropathy;
- •8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1;
- •9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;
- •10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.
排除标准
- •1.With ≥2 degree of peripheral neuropath or with pain;
- •2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;
- •3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;
- •4.Patients in pregnancy or lactation;
- •5.Allergic constitution or being allergic to any drug within the regimen of the trial;
- •6.With uncontrolled mental diseases;
- •7.With active infection;
- •8.With non-myeloma-associated acute renal dysfunction;
- •9.With active hepatitis;
- •10.HIV positive;
- •11.History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;
- •12.With other conditions that the investigators think unfit for the trial.
研究组 & 干预措施
Chidamide plus VRD
Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
干预措施: Chidamide+VRD (Drug)
VRD
Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
干预措施: VRD (Drug)
结局指标
主要结局
complete remission rate
时间窗: at the time point 1 month after the last cycle
complete remission rate after treated by the corresponding regimen
incidence and severity of adverse events
时间窗: from the date of the start of treatment to 36 months after last patient's enrollment
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
次要结局
- progression free survival(from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment;)
- overall survival(from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment)