Prospective, Multicenter, Open and Non-interference Observational Clinical Study of Daratumumab, Pomalidomide and Dexamethasone (Dara-PD) in the Treatment of Patients With First Relapse of Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the second progression free survival time (PFS2)
研究概览
简要总结
At present, there is no prospective study on the treatment of first-relapsed multiple myeloma with daratumumab plus pomalidomide and dexamethasone (Dara-Pd). A prospective, multicenter, open, non-interventional, observational clinical study to evaluate the efficacy and safety of Dara-Pd in patients with first relapse multiple myeloma.
详细描述
To evaluate the impact of daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma. Among them, the second progression free survival time (PFS2) is defined as the time from enrollment to disease progression or death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Subjects will be enrolled in this study only if they met all of the following inclusion criteria.
- •Age 18 years or older, regardless of gender.
- •Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease
- •First relapse of multiple myeloma;
- •Receiving first-line anti-multiple myeloma therapy;
- •The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD);
- •Subject must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen;
- •Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- •Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.
排除标准
- •Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma.
- •Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course；
- •Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy；
- •Subject has received daratumumab or pomalidomide previously；
- •Subject has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions is malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).；
- •Subjects with uncontrollable psychiatric disorders;
- •Subject is known or suspected of not being able to comply with the study protocol.Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.
研究组 & 干预措施
daratumumab, pomalidomide, and dexamethasone (Dara-PD)
the first relapse of patients who received daratumumab, pomalidomide, and dexamethasone (Dara-PD) treatment
other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd)
the first relapse of patients who received other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) treatment
结局指标
主要结局
the second progression free survival time (PFS2)
时间窗: through study completion, up to 2 years
daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma.
次要结局
- Treatment related adverse event(AE)(From enrollment through follow-up (up to 24 months).)
- Overall survival (OS)(through study completion, up to 2 years)
- Objective Response Rate (ORR)(through study completion, up to 2 years)
- Deep response rate (≥ VGPR)(through study completion, up to 2 years)
- MRD negative(through study completion, up to 2 years)
- continuous MRD negative rate(through study completion, up to 2 years)
- Evaluation of duration of remission (DOR)(through study completion, up to 2 years)
研究者
FengYan Jin
Clinical Professor of Hematology Department
The First Hospital of Jilin University