NCT00999414No Longer Available不适用
Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.
详细描述
The protocol has been designed for relapsing or refractory multiple myeloma patients. A maximum of 30 patients may be treated on this protocol.
Since this is a compassionate use study of an investigational agent, the size is determined by agreement with the manufacturer of carfilzomib. Therefore, the time period for enrollment and accrual number will be limited to N=30.
研究设计
- 研究类型
- Expanded Access
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
- •Participants must have histologically documented multiple myeloma which is relapsing or resistant after stem cell transplantation, or when other conventional therapies have failed or are contraindicated
- •Serum creatinine < 3.0 mg/dL OR calculated creatinine clearance >15 mL/min calculated or measured clearance is ≥15 mL/min
- •ANC > 1000/mm3 (may be supported with growth factors)
- •Platelet count > 30,000/mm3 (may receive transfusion)
- •Female participant of child-bearing potential has agreed to use dual methods of contraception for the duration of the study
- •Male participant has agreed to use a barrier method of contraception if sexually active with a female of child-bearing potential
- •Patients must have signed and IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations
排除标准
- •Active infection requiring systemic treatment
- •Requires concomitant use of approved or investigative anticancer therapeutic treatment with activity against multiple myeloma, other than dexamethasone
- •Concomitant use of other investigative agents (e.g., antibiotics or antiemetics)
- •Pregnant or breast-feeding
研究者
研究点 (1)
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