NCT01094548已完成2 期
A Randomized, Open-label, Phase II Study With Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Subjects With Either Chemotherapy-naïve, Slowly Progressive, Asymptomatic Multiple Myeloma or With Stage II/III Multiple Myeloma in Stable Response/Plateau Phase Following Anti-tumor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response
研究概览
简要总结
Tecemotide (L-BLP25) is believed to induce a Mucinous glycoprotein 1 (MUC1)-specific T-cell response after vaccination. The primary purpose of this study is to ascertain whether vaccination with tecemotide (L-BLP25) induces a MUC1-specific T-cell response in slowly progressive or chemotherapy naive multiple myeloma subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Documented previously untreated, Mucinous glycoprotein 1 (MUC1)-expressing, slowly progressive asymptomatic multiple myeloma with an increasing M-protein concentration displayed on two occasions separated by an interval of at least 4 weeks within the last 18 months, or
- •Documented MUC1-expressing stage II or III multiple myeloma with a treatment-free interval of at least 3 months following prior anti-tumor therapy, and fulfilling criteria for having a stable response/plateau phase
- •Signed written informed consent
- •MUC1-expressing myeloma cells in the bone marrow
- •Greater than or equal to (>=) 18 years of age
- •Life expectancy of at least 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1 at study entry
- •Effective contraception for both male and female subjects, if the possibility of conception exists
- •A platelet count >=100 x 10^9/Liter, white blood cells >=2.5 x 10^9/Liter, and hemoglobin >=90 gram per liter (g/L)
- •Total bilirubin <= 1.5 x upper reference range
- •Aspartate aminotransferase (AST) <= 2.5 x upper reference range
- •Serum creatinine <= 2 x upper reference
排除标准
- •Pre-Therapies:
- •Previous exposure to MUC1 targeting therapy
- •Radiotherapy or any investigational drug in the 30 days before the start of treatment in this study
- •Receipt of immunotherapy (Example: interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization
- •Any preexisting medical condition requiring chronic oral or intravenous steroid or immunosuppressive therapy except for maintenance doses of prednisone of <=10 milligram per day (mg/day)
- •Medical Conditions:
- •Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study
- •Hereditary or congenital immunodeficiencies
- •Known hypersensitivity reaction to any of the components of study treatments
- •Clinically significant cardiac disease, Example: New York Heart Association (NYHA) classes III-IV; unstable angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months
- •Other previous malignancies within 5 years, with exception of a history of a previous basal cell carcinoma of the skin, carcinoma in situ of uterine cervix, gastrointestinal intramucosal carcinoma
- •Known Hepatitis B and/or C
- •Splenectomy
- •Standard Safety:
- •Known alcohol or drug abuse
- •Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
- •Significant disease which, in the investigator's opinion, would exclude the subject from the study
- •Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator. Subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard
- •Participation in another clinical study within the past 30 days
- •Legal incapacity or limited legal capacity
- •Concurrent treatment with a non-permitted drug
- •Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study
研究组 & 干预措施
Tecemotide (L-BLP25) plus single low dose cyclophosphamide
Experimental
干预措施: Tecemotide (L-BLP25) (Biological)
Tecemotide (L-BLP25) plus single low dose cyclophosphamide
Experimental
干预措施: Single low dose cyclophosphamide (Drug)
Tecemotide (L-BLP25) plus multiple low dose cyclophosphamide
Experimental
干预措施: Tecemotide (L-BLP25) (Biological)
Tecemotide (L-BLP25) plus multiple low dose cyclophosphamide
Experimental
干预措施: Multiple low dose cyclophosphamide (Drug)
结局指标
主要结局
Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response
时间窗: From the date of randomization up to Week 104
The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon \[IFN\] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell \[PBMC\]) with ratio to background \>=2, and ratio of background-corrected value to baseline \>=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS\[t\]=1), upon fulfilling the following criteria: Yt =\>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t \> AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).
次要结局
- Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response(Baseline and Week 9)
- Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type(From the date of randomization up to Week 104)
- Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR](From the date of randomization up to Month 48)
- Time to Progression (TTP)(From the date of randomization up to Month 48)
- Time to Anti-tumor Therapy(From the date of randomization up to Month 48)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)(From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012))
研究者
研究点 (1)
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