A Phase 1/2a Dose Escalation Study of PVX-410, a Multi-Peptide Cancer Vaccine, in Patients With Smoldering Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 12
- 主要终点
- All adverse events will be recorded.
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.
详细描述
This is a dose escalation, phase 1/2a study to assess the safety and tolerability of PVX-410, (a multi-peptide cancer vaccine), treatment regimen in patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.. Approximately 22 patients will receive six (6) bi-weekly, subcutaneous injections of PVX-410 for a total of twelve (12) weeks of treatment. Safety will be monitored throughout the study. Tolerability, immunogenicity and clinical response will also be measured as described in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patient has symptomatic multiple myeloma, as defined by any of the following:
- •Lytic lesions or pathologic fractures.
- •Anemia (hemoglobin <10 g/dL).
- •Hypercalcemia (corrected serum calcium >11.5 mg/dL).
- •Renal insufficiency (creatinine >2 mg/dL).
- •Other: symptomatic hyperviscosity, amyloidosis.
- •Patient has abnormal cardiac status, evidenced by any of the following:
- •New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
- •Myocardial infarction within the previous 6 months.
- •Symptomatic cardiac arrhythmia requiring treatment or persisting despite treatment.
- •Patient is receiving any other investigational agent.
- •Patient has a current active infectious disease or positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- •Patient has a history of or current auto-immune disease.
- •Patient has been vaccinated with live attenuated vaccines within 4 weeks before study vaccination.
结局指标
主要结局
All adverse events will be recorded.
时间窗: Throughout treatment phase (3 months) and follow up period (12 months)
次要结局
- Immune response to the vaccine will be measured(Designated timepoints during the treatment phase (3 months) and follow up phase (12 months))