NCT00664898已完成1 期
An Open-Label, Phase Ib, Dose-Escalation Study of the Safety and Pharmacology of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination With Bortezomib (Velcade®, PS-341) in Patients With Relapsed or Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Determine the maximum tolerated dose of SGN-40 when combined with bortezomib
研究概览
简要总结
This is an open-label, multicenter, Phase Ib study to be conducted at approximately eight sites in Europe and the U.S. designed to evaluate the safety, pharmacokinetics, and activity of SGN-40 when combined with bortezomib in patients with multiple myeloma that is relapsed or refractory after at least one prior systemic treatment regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Documented pathologic diagnosis of multiple myeloma that has relapsed or failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy)
- •Measurable disease
- •At least one prior systemic therapy other than single-agent corticosteroids
- •European Union patients must have had prior bone marrow transplant (autologous) or be ineligible for transplant
- •If previously received bortezomib, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥ 6 months from the start of that therapy
- •If previously received bortezomib, must have recovered from bortezomib-related toxicities and must have a peripheral neuropathy score of Grade ≤ 1, according to the NCI CTCAE v3.0
- •If applicable, completion of autologous transplant ≥ 12 weeks prior to Day 1
- •Discontinuation of previous anticancer or investigational therapy for ≥ 21 days prior to treatment, or ≥ 90 days prior to treatment for previous monoclonal antibody administration
排除标准
- •Prior allogeneic bone marrow transplant
- •Other invasive malignancies within 3 years prior to Day 1 except for adequately treated basal cell or squamous cell skin cancer; carcinoma in situ of the cervix, breast, or prostate; or other cancer of which the patient has been disease-free for ≥ 3 years
- •Prior anaphylactic reaction to human immunoglobulin administration
- •Symptomatic hyperviscosity syndrome
- •Active infection requiring parenteral antibiotics within 14 days of Day 1
- •Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- •Clinically significant cardiac dysfunction or other significant organ dysfunction
研究组 & 干预措施
1
Experimental
干预措施: bortezomib (Drug)
1
Experimental
干预措施: SGN-40 (Drug)
结局指标
主要结局
Determine the maximum tolerated dose of SGN-40 when combined with bortezomib
时间窗: Length of study
次要结局
- Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib(Length of study)
研究者
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