NL-OMON31502招募中不适用
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. - GNE ACF4375g
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Genentech
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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, defined as follows:
- •Serum M-protein >= 1 g/dL (>= 10 g/L)
- •Urine M-protein >= 200 mg/24 hr urine collection
- •Involved FLC level >= 10 mg/dL (>= 100 mg/L, provided serum FLC ratio is abnormal)
- •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 (note: the requirement for prior transplant is based on the approved indication for bortezomib in the European Union at the time the protocol was finalized).
- •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
- •ECOG performance status of 0 or 1 (see Appendix F)
- •Life expectancy of > 3 months
排除标准
- •Prior treatment with a monoclonal antibody directed against CD40
- •Prior allogeneic bone marrow transplant
- •Concurrent systemic corticosteroid therapy (except corticosteroid therapy <= 20 mg/day prednisone or equivalent used to treat an illness other than lymphoma)
- •clinical laboratory values:
- •ANC < 1000/µL
- •Platelet count < 75,000/µL
- •Total bilirubin > 1.6 mg/dL AST or ALT greater than the upper limit of normal (ULN) Serum creatinine > 1.5 times upper limit of normal or calculated creatinine
- •clearance < 50 mL/min
- •Hemoglobin < 9 g/dL (may be transfused to maintain or exceed this level) ;• 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
- •Known intracranial disease or epidural disease
- •Patients with lytic lesions of the cranium secondary to myeloma are eligible to enroll.
- •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
- •Serious, nonhealing wound, ulcer, or bone fracture
- •Clinically significant cardiac disease (New York Heart Association, Class III or IV), including preexisting arrhythmia, congestive heart failure, or cardiomyopathy
- •Any contraindication to bortezomib treatment, including hypersensitivity to bortezomib, boron, or mannitol
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