A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 682
- 试验地点
- 112
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.
The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.
In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.
The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent.
- •Patients must have documented diagnosis of Multiple Myeloma and have measurable disease.
- •Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy.
- •Patients must have either refractory or relapsed and refractory disease.
- •Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens.
- •Patients must have received adequate alkylator therapy
排除标准
- •Prior history of malignancies, other than Multiple Myeloma.
- •Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone.
- •Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant.
- •Patients who are planning for or who are eligible for stem cell transplant.
- •Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment.
- •Patients with a current disease that can interfere with protocol procedures or study treatment.
- •Patients unable or unwilling to undergo antithrombotic prophylactic treatment.
- •Pregnant or breastfeeding females.
研究组 & 干预措施
Pomalidomide plus Dexamethasone
Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.
干预措施: Pomalidomide (Drug)
Pomalidomide plus Dexamethasone
Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAE)
时间窗: From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs. A SAE = AE occurring at any dose that: * Results in death; * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect
次要结局
- Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines(From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months)
- Time to Response(Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks)
- Kaplan Meier Estimate of Duration of Response(From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months)
- Kaplan Meier Estimate of Overall Survival (OS)(From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months)
- Cytogenetic Analysis(Study entry)
- Pomalidomide Exposure - Apparent Volume of Distribution (V/F)(Cycles 1, 2, 3, 4, 5, 6)
- Overall Response(Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks)
- Kaplan Meier Estimate of Time to Progression(From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months)
- Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)(Cycles 1, 2, 3, 4, 5, 6)