Phase 1/2 Study of VELCADE® (Bortezomib), Dexamethasone, and Revlimid® (Lenalidomide) Versus VELCADE, Dexamethasone, Cyclophosphamide, and Revlimid Versus VELCADE, Dexamethasone and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Number of Patients With Combined Complete Response and Very Good Partial Response
研究概览
简要总结
The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.
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
- •Voluntary written informed consent
- •Male or female subject 18 years of age or older
- •A Karnofsky Performance Status score of ≥50% (Eastern Cooperative Oncology Group Performance Status score ≤2)
- •Subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage
- •Diagnosed Multiple myeloma
- •Subjects must have measurable disease requiring systemic therapy
- •Subjects must not have been treated previously with any systemic therapy for multiple myeloma
- •Two weeks must have elapsed since the date of the last radiotherapy treatment
- •Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to therapy and repeated within 24 hours before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of Revlimid treatment. Women must also agree to ongoing pregnancy testing
- •Men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential
- •All subjects must agree to comply with the requirements of the RevAssistSM program
排除标准
- •History of allergy to any of the study medications, their analogues, or excipients in the various formulations
- •≥Grade 2 peripheral neuropathy on clinical examination
- •Myocardial infarction within 6 months prior to enrollment or New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities.
- •Female subject who is pregnant or breast-feeding
- •Clinically relevant active infection or serious comorbid medical conditions
- •Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study. This includes but is not limited to serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Active prior malignancy diagnosed or treated within the last 3 years
研究组 & 干预措施
VDR
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide)
干预措施: VELCADE (bortezomib) (Drug)
VDR
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide)
干预措施: dexamethasone (Drug)
VDR
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide)
干预措施: Revlimid (lenalidomide) (Drug)
VDCR
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide)
干预措施: VELCADE (bortezomib) (Drug)
VDCR
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide)
干预措施: dexamethasone (Drug)
VDCR
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide)
干预措施: cyclophosphamide (Drug)
VDCR
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide)
干预措施: Revlimid (lenalidomide) (Drug)
VDC
VELCADE (bortezomib), dexamethasone, cyclophosphamide
干预措施: VELCADE (bortezomib) (Drug)
VDC
VELCADE (bortezomib), dexamethasone, cyclophosphamide
干预措施: dexamethasone (Drug)
VDC
VELCADE (bortezomib), dexamethasone, cyclophosphamide
干预措施: cyclophosphamide (Drug)
VDC-mod
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide
干预措施: VELCADE (bortezomib) (Drug)
VDC-mod
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide
干预措施: dexamethasone (Drug)
VDC-mod
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
Number of Patients With Combined Complete Response and Very Good Partial Response
时间窗: Up to 48 weeks or until disease progression
Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h
次要结局
- Number of Patients With Adverse Events (AEs)(From first dose of study drug through the 30 day post-treatment AE assessment visit)
- Number of Patients With Overall Response(Up to 48 weeks or until disease progression)
- Number of Patients With Stringent Complete Response Rate(Up to 48 weeks or until disease progression)
- Number of Patients With Complete Response Rate + Near Complete Response Rate(Up to 48 weeks or until disease progression)
- Duration of Response(Up to 48 weeks or until disease progression)
- Time to Disease Progression(Up to 48 weeks or until disease progression)
- Time to Response(Up to 48 weeks or until disease response)
- Progression-free Survival(Up to 48 weeks or until disease progression/death)
- Probability of 1-year Survival(survival probability at 1 year after randomization)
- Overall Survival(Up to 48 weeks or until death)