Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Mean Duration of Treatment With Vorinostat
研究概览
简要总结
The purposes of this study are:
- To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
- To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Adults with refractory or relapsed multiple myeloma
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
- •Adequate bone marrow reserve
- •Adequate hepatic and renal function
- •Ability to swallow capsules
- •3 weeks or more since prior chemotherapy and have recovered from prior toxicities
排除标准
- •Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment
- •Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
- •Participants with other active/uncontrolled clinically significant illness
- •Pregnant or nursing female participants
- •Participants who received bortezomib within 3 months of start of this trial
研究组 & 干预措施
vorinostat 200 mg + bortezomib 0.7 mg/m^2
Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
干预措施: vorinostat (Drug)
vorinostat 200 mg + bortezomib 0.7 mg/m^2
Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
干预措施: bortezomib (Drug)
vorinostat 200 mg + bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
干预措施: vorinostat (Drug)
vorinostat 200 mg + bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
干预措施: bortezomib (Drug)
vorinostat 300 mg + bortezomib 1.3 mg/m^2
Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.
干预措施: vorinostat (Drug)
vorinostat 300 mg + bortezomib 1.3 mg/m^2
Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.
干预措施: bortezomib (Drug)
vorinostat 400 mg + bortezomib 0.9 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
干预措施: vorinostat (Drug)
vorinostat 400 mg + bortezomib 0.9 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
干预措施: bortezomib (Drug)
vorinostat 400 mg + bortezomib 1.1 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
干预措施: vorinostat (Drug)
vorinostat 400 mg + bortezomib 1.1 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
干预措施: bortezomib (Drug)
vorinostat 400 mg + bortezomib 1.3 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
干预措施: vorinostat (Drug)
vorinostat 400 mg + bortezomib 1.3 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
干预措施: bortezomib (Drug)
结局指标
主要结局
Mean Duration of Treatment With Vorinostat
时间窗: Day 1 to an event causing discontinuation from the study, assessed up to 29 months
Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity. Progressive disease was defined as: * \>25% increase in the level of serum monoclonal paraprotein. * 25% increase in 24-hour urinary light chain excretion. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy. * Development of new bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia. Intolerable toxicity was based on the clinical judgment of the investigator.
次要结局
- Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug(Day 1 to disease progression, toxicity, or death, assessed up to 29 months)
- Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib(Day 1 to disease progression, toxicity, or death, assessed up to 29 months)
- Clinical AE Summary(Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months))
- Laboratory AE Summary(Day 1 up to disease progression, toxicity, or death, assessed up to 29 months)