A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Subjects With Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 主要终点
- Complete Response Rate: Number of Participants Who Achieved a Complete Response
研究概览
简要总结
The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.
详细描述
This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone versus DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4 to 12 treatment cycles, depending on the response of their multiple myeloma to the treatment (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection). Maximum duration of study participation for each participant will be 48 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group [IMWG] criteria
- •Eastern Cooperative Oncology Group (ECOG) status 0-2
- •Adequate absolute neutrophil count (ANC), platelet count and hemoglobin
- •Adequate serum calcium
- •Enrollment in System for Thalidomide Education and Prescribing Safety Program (S.T.E.P.S.)
排除标准
- •No treatment with dexamethasone for multiple myeloma
- •No peripheral neuropathy of Grade 2 or higher
- •No Left Ventricular Ejection Fraction (LVEF) of less than 45 percentage
- •No history of life-threatening thromboembolic events of any kind (ie, myocardial infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in the study
- •No deep vein thrombosis (DVT) within 1 year of enrollment
- •No current anticoagulation for DVT
研究组 & 干预措施
Thalidomide + dexamethasone
干预措施: Thalidomide (Drug)
Thalidomide + dexamethasone
干预措施: Dexamethasone (Drug)
Thalidomide + dexamethasone + DOXIL
干预措施: Thalidomide (Drug)
Thalidomide + dexamethasone + DOXIL
干预措施: Dexamethasone (Drug)
Thalidomide + dexamethasone + DOXIL
干预措施: DOXIL (Drug)
结局指标
主要结局
Complete Response Rate: Number of Participants Who Achieved a Complete Response
时间窗: From Cycle 2 until 28 days following completion of treatment
Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.
次要结局
- Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)(From Cycle 2 until 28 days following completion of treatment)
- Time to 1st Response(From Cycle 2 until 28 days following completion of treatment)
- Time to Progression(From randomization until death or as assessed up to 2 years post last participant last treatment visit)
- Overall Survival: Number of Participants Died Due to Any Cause(From randomization until death or as assessed up to 2 years post last participant last treatment visit)
- Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)(From randomization until death or as assessed up to 2 years post last participant last treatment visit)
- Engraftment: Number of Participants Who Underwent Engraftment(From randomization until death or as assessed up to 2 years post last participant last treatment visit)