Phase 2 Trial of Leflunomide in African-American and European-American Patients With High-Risk Smoldering Multiple Myeloma
概览
- 阶段
- 2 期
- 干预措施
- Cholestyramine
- 疾病 / 适应症
- Smoldering Plasma Cell Myeloma
- 发起方
- City of Hope Medical Center
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Progression to multiple myeloma
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
This phase II trial studies the effects of leflunomide in treating African-American and European-American patients with high-risk smoldering multiple myeloma. Leflunomide is used to decrease the body's immune response and may delay the symptoms of multiple myeloma in patients of African-American and European decent.
详细描述
PRIMARY OBJECTIVES: I. To evaluate the anti-myeloma activity of leflunomide, when given as a single agent, as assessed by freedom from progression at 2-years. II. To evaluate the safety and tolerability of single agent leflunomide. SECONDARY OBJECTIVES: I. To summarize and assess toxicities by type, frequency, severity, attribution, time course and duration. II. To estimate overall and progression-free survival probabilities. III. To estimate response rate and duration of response. IV. To describe the impact of treatment on quality of life, as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score version (v)3.0. EXPLORATORY OBJECTIVES: I. To characterize the molecular evolution of the tumor cells. II. To evaluate whether specific genetic subtypes respond differently to leflunomide. III. To evaluate the role of immune cells in the progression of smoldering multiple myeloma (SMM). IV. To evaluate the role of leflunomide in modulating the immune system. V. To examine the relationship between immunological changes and disease progression. OUTLINE: Patients receive leflunomide orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up yearly.
研究者
入排标准
入选标准
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
- •Patients must be age \>= 18 years
- •Patients must have a life expectancy of \> 24 months
- •Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Patients must identify as African-American OR European-American
- •Patients must have a diagnosis of high risk smoldering multiple myeloma, as defined below:
- •The presence of \>= 2 of the following risk factors:
- •Bone marrow plasma cell percentage (BMPC%) \> 20%
- •Serum M-protein \> 2 g/dL
- •Free light chain ratio (FLCr) \> 20
排除标准
- •Prior treatment with leflunomide
- •Prior treatment for smoldering multiple myeloma
- •Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period. Current or planned growth factor or transfusion support until after initiation of treatment. If growth factor or transfusion support is provided between screening and start of treatment, the participant will no longer be eligible
- •Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
- •Hypercalcemia: serum calcium \> 0.25 mmol/L (\> 1 mg/dL) higher than the upper limit of normal or \> 2.75 mmol/L (\> 11 mg/dL)
- •Renal insufficiency: creatinine clearance \< 30 mL per min or serum creatinine \> 177 umol/L (\> 2 mg/dL)
- •Anemia: hemoglobin value of \> 20 g/L below the lower limit of normal, or a hemoglobin value \< 10 g/dL
- •Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT
- •Any one or more of the following biomarkers of malignancy:
- •Clonal bone marrow plasma cell percentage \>= 60%
研究组 & 干预措施
Treatment (leflunomide)
Patients receive leflunomide PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Cholestyramine
Treatment (leflunomide)
Patients receive leflunomide PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Leflunomide
结局指标
主要结局
Progression to multiple myeloma
时间窗: At 2 years
Incidence of adverse events
时间窗: Up to 30 days after last dose
Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, serum concentration of the active leflunomide metabolite, probable association with the study treatment and reversibility or outcome.
次要结局
- Overall survival(From start of treatment to death, or last follow-up, whichever comes first, assessed up to 2 years)
- Progression-free survival(From randomization to progression or death or loss to follow up, whichever comes first, assessed up to 2 years)
- Freedom-from progression(From start of treatment to the first assessment showing symptomatic disease, assessed up to 2 years)