A Phase II Trial of Vaccination With Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Patients Who Develop Immunologic Response to Nivolumab and the DC/MM Fusion Vaccine
研究概览
简要总结
This research study is studying a cancer vaccine called Dendritic Cell/MM Fusion vaccine (DC/MM vaccine) in combination with nivolumab, as a possible treatment for multiple myeloma (MM).
The drugs involved in this study are:
- Dendritic Cell/MM Fusion vaccine (DC/MM vaccine)
- Nivolumab, an immunotherapy drug
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved the DC/MM vaccine as a treatment for any disease.
The FDA has not approved nivolumab for multiple myeloma. A similar immunotherapy drug used in combination with IMiDs (drugs that regulate or modify the immune system) was associated with higher risk of death in another research trial in patients with multiple myeloma; however, nivolumab has been approved for use in several other types of cancers.
The FDA has not approved the combination of nivolumab with the DC/MM vaccine as a treatment for any disease.
In this research study, the investigators wish to determine whether nivolumab administered in combination with the DC/MM vaccine will help promote an immune response against multiple myeloma cells.
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 Patients with relapsed multiple myeloma with prior treatment of an IMID and proteasome inhibitor.
- •Age ≥18 years.
- •ECOG performance status ≤2
- •Patients must have > 20% plasma cells in the bone marrow aspirate differential <30 days prior to enrollment.
- •ANC > 1000; Platelets > 75K without transfusional support
- •Participants must have normal organ function as defined below:
- •total bilirubin ≤1.5 × institutional upper limit of normal
- •AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal
- •creatinine clearance ≥40 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- •The effects of DC/MM fusion and nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 5 months after completion of treatment.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Participants who are receiving any other investigational agents.
- •3.2.2 Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain >100 mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
- •Patients with Plasma Cell Leukemia
- •Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).
- •Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
- •Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:
- •GI Disorders: (including inflammatory bowel disease [e.g. ulcerative colitis, Crohn's disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea.
- •Systemic lupus erythematosus
- •Wegener's syndrome [granulomatosis with polyangiitis]
- •Myasthenia gravis
- •Graves' disease
- •Rheumatoid arthritis
- •Hypophysitis
- •The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.
- •Individuals with a history of a different malignancy are ineligible except for the following circumstances. Note: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.
- •Female patients who are pregnant (positive β-HCG) or breastfeeding
- •Prior organ transplant requiring immunosuppressive therapy.
- •Patients who previously received PD-1 antibody and have experienced toxicities resulting in treatment discontinuation.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Nivolumab+DC/myeloma fusions/GM-CSF
- Nivolumab will be given every two weeks
- The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
干预措施: Nivolumab (Drug)
Nivolumab+DC/myeloma fusions/GM-CSF
- Nivolumab will be given every two weeks
- The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle
干预措施: DC/myeloma fusions/GM-CSF (Biological)
结局指标
主要结局
Number of Patients Who Develop Immunologic Response to Nivolumab and the DC/MM Fusion Vaccine
时间窗: 2 years
We planned to evaluate the immunologic response to treatment in blood and bone marrow. Two patients were treated on protocol and both came off due to disease progression early in the course of therapy (one patient during cycle 1 and one patient during cycle 3.) As such, there is insufficient data to perform what had been planned in correlative science studies so no samples were analyzed. This study has been stopped and no further patients are being enrolled and no further samples are being collected. No data has been obtained for any immune analysis; therefore no immune or clinical data will be reported on this trial.
次要结局
- Number of Patients Who Achieve a Clinical Response (SD, PR, VGPR, CR)(2 years)
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0(2 years)
- Number of Patients Who Are Alive Without Progression at 2 Years(2 years)
研究者
Jacalyn Rosenblatt
Principal Investigator
Beth Israel Deaconess Medical Center