NCT00079716已完成1 期
A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent 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
- 发起方
- Seagen Inc.
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Adverse events and lab abnormalities.
研究概览
简要总结
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.
详细描述
This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma.
A minimum of three patients will be entered into each dose-level cohort. All patients will receive a dose-loading schedule during the first two weeks. The maximum weekly dose will be 16mg/kg.
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
- •Patients must have refractory or recurrent secretory multiple myeloma (MM).
- •Patients must have failed at least two different prior systemic therapies for MM.
- •Patients may have received a maximum of five cytotoxic regimens.
- •Patients who have received any of the following must complete within the specified time frame below:
- •Autologous stem cell transplant - 12 weeks prior to first dose
- •Nitrogen Mustard agents, Melphalan, BCNU, IVIG, or monoclonal antibody therapy - 6 weeks prior to first dose
- •Chemotherapy, Radiation, or other therapies for MM - 4 weeks prior to first dose
- •Patients who have not undergone autologous stem cell transplantation must be either ineligible for stem cell transplantation or, if eligible, must have refused treatment by autologous stem cell transplantation.
- •Patients must have an ECOG performance status of ≤ 2 and a life expectancy > three months.
- •Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution for the entire duration of the study.
- •Patients must be at least 18 years of age.
- •Females of childbearing potential must have a negative β-HCG pregnancy test result within three days of enrollment. All patients must plan to use an effective contraceptive method during the course of the study.
- •Patients must meet baseline lab data requirements.
- •Patients must give written informed consent.
排除标准
- •Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia.
- •Patients with a history of allogeneic transplantation.
- •Patients receiving plasmapheresis within four weeks prior to enrollment.
- •Patients undergoing major surgery within four weeks prior to enrollment.
- •Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
- •Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ.
- •Patients with any active viral, bacterial, or systemic fungal infection within four weeks of enrollment.
- •Patients with a history of significant chronic or recurrent infections requiring treatment.
- •Patients with a history of active thrombosis within three months of enrollment.
- •Patients with a history of pulmonary embolism.
- •Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
- •Patients who are pregnant or breastfeeding.
- •Patients with uncontrolled hypercalcemia.
- •Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
- •Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.
研究组 & 干预措施
1
Experimental
干预措施: SGN-40 (anti-huCD40 mAb) (Drug)
结局指标
主要结局
Adverse events and lab abnormalities.
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
已完成
1 期
A Safety Study of SGN-40 in Patients With Non-Hodgkin's LymphomaNon-Hodgkin LymphomaNCT00103779Seagen Inc.50
已完成
1 期
Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple MyelomaMultiple MyelomaNCT00525447Seagen Inc.36
已完成
1 期
A Safety Study in Patients With Chronic Lymphocytic LeukemiaLeukemia, Lymphocytic, ChronicNCT00283101Seagen Inc.12
已完成
2 期
Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinNCT00435916Seagen Inc.46
已完成
1 期
A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic MalignanciesHodgkin DiseaseLymphoma, Large-CellSarcoma, KaposiLymphoma, T-Cell, CutaneousLymphoma, B-CellNCT00051597Seagen Inc.70