A Phase 3, Randomized, Open-label Study of Subcutaneous and Intravenous VELCADE in Combination With Dexamethasone in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Overall Response Rate After 4 Cycles of Velcade Treatment
研究概览
简要总结
The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to intravenous velcade when administered in combination with low-dose dexamethasone in chinese refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall response rate after 4 cycles of velcade and dexamethasone administration.
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
- •Have received at least 1 and no more than 3 prior lines of therapy for multiple myeloma
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •The toxicities resulting from previous therapy must be resolved or stabilized to less than or equal (<=)Grade 1 prior to drug administration
- •A woman of childbearing potential must have a negative highly sensitive serum (human chorionic gonadotropin [hCG]) or urine pregnancy tests at screening within 14 days prior to Cycle 1 Day 1
- •Have documented evidence of progressive disease/disease progression based on investigator's determination of response by the International Myeloma Working Group (IMWG) criteria on or after their last regimen
排除标准
- •Received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day (mg/day) for a maximum of 4 days) before treatment.
- •Received autologous stem cell transplant (ASCT) within 12 weeks before the date of randomization, or the participant has previously received an allogenic stem cell transplant (regardless of timing)
- •Plans to undergo a stem cell transplant prior to progression of disease on this study, that is, these participants should not be enrolled in order to reduce disease burden prior to transplant
- •Is known to be infected with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C
- •Had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities
研究组 & 干预措施
Group 1 : Intravenous Bortezomib plus Dexamethasone
Participants will receive a 1.3 milligram per square meter per dose (mg/m^2) bortezomib intravenously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).
干预措施: Bortezomib (Drug)
Group 1 : Intravenous Bortezomib plus Dexamethasone
Participants will receive a 1.3 milligram per square meter per dose (mg/m^2) bortezomib intravenously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).
干预措施: Dexamethasone (Drug)
Group 2 : Subcutaneous Bortezomib plus Dexamethasone
Participants will receive a 1.3 milligram per square meter per dose (mg/m^2) bortezomib subcutaneously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).
干预措施: Bortezomib (Drug)
Group 2 : Subcutaneous Bortezomib plus Dexamethasone
Participants will receive a 1.3 milligram per square meter per dose (mg/m^2) bortezomib subcutaneously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Overall Response Rate After 4 Cycles of Velcade Treatment
时间窗: 12 weeks (after 4 cycles; each cycle is of 3 weeks)
ORR defined as the proportion of participants who achieve either complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\], according to the International Myeloma Working Group (IMWG) criteria. Participants with CR, VGPR, or PR that is unconfirmed in Cycle 4 but confirmed in the next response assessment will be included as CR, VGPR or PR, respectively.
次要结局
- Time to progression (TTP)(Maximum up to 4 years 7 months)
- Duration of response (DOR)(Maximum up to 4 years 7 months)
- Time to best response(Maximum up to 4 years 7 months)
- Complete Response (CR) and Very Good Partial Response (VGPR) after 4 cycles(12 weeks (after 4 cycles; each cycle is of 3 weeks))
- Overall Response Rate (ORR) after 8 cycles(24 weeks (after 8 cycle; each cycle is of 3 weeks))
- Progression-Free Survival (PFS)(Maximum up to 4 years 7 months)
- One-year survival rate(1 year after last patient randomization)
- Time to response(Maximum up to 4 years 7 months)
- Area Under the Plasma ConcentrationTime Curve From Time 0 to Last Observed Quantifiable Concentration AUC [0-last](Cycle 1 of Day 1, Day 11 to Day 14)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Cycle 1 of Day 1, Day 11 to Day 14)
- Number of Participants with Treatment-Related Adverse Events and Serious Treatment-Related Adverse Events(Maximum up to 4 years 7 months)
- Maximum Observed Plasma Concentration (Cmax)(Cycle 1 of Day 1, Day 11 to Day 14)