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
- 6
- 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
- •Patient has confirmed clinical diagnosis of SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition: serum M-protein ≥3 g/dL or bone marrow clonal plasma cells (BMPC) greater than or equal to 10%, or both, along with normal organ and marrow function (CRAB) within 4 weeks before baseline.
- •C: Absence of hypercalcemia, evidenced by a calcium <10.5 mg/dL.
- •R: Absence of renal failure, evidenced by a creatinine <2.0 mg/dL or calculated creatinine clearance (using the Modification of Diet in Renal Disease [MDRD] formula) >50 mL/min.
- •A: Absence of anemia, evidenced by a hemoglobin >10 g/dL.
- •B: Absence of lytic bone lesions on standard skeletal survey.
- •Patient is at higher than average risk of progression to active MM, defined as having 2 or more of the following features:
- •Serum monoclonal (M)-protein ≥3 g/dL.
- •BMPC greater than or equal to 10%.
- •Abnormal serum free light chain (FLC) ratio (0.26-1.65).
- •Patient has a life expectancy of greater than 6 months
- •Patient is human leukocyte antigen (HLA)-A2 positive.
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Patient has adequate bone marrow function, evidenced by a platelet count ≥75×109/L and an absolute neutrophil count (ANC) ≥1.0×109/L within 2 weeks before baseline.
- •Patient has adequate hepatic function, evidenced by a bilirubin ≤2.0 mg/dL and an alanine transaminase (ALT), and aspartate transaminase (AST) ≤2.5× the upper limit of normal (ULN) within 2 weeks before baseline.
- •If of child-bearing potential, patient agrees to use adequate birth control measures during study participation.
- •If a female of child-bearing potential, patient has negative urine pregnancy test results within 2 weeks before baseline and is not lactating.
- •Patient (or his or her legally accepted representative) has provided written informed consent to participate in the study.
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.
研究组 & 干预措施
PVX-410 plus lenalidomide
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of an .8 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will also receive 3 cycles of lenalidomide. Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
干预措施: PVX-410 (Biological)
PVX-410, .8 mg dose
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of an .8 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months.
干预措施: PVX-410 (Biological)
PVX-410, .4 mg dose
Approximately 3 patients will receive 6, bi-weekly, subcutaneous injections of a .4 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months.
干预措施: PVX-410 (Biological)
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))