2024-519353-11-00招募中2 期
Iceland Screens Treats or Prevents Multiple Myeloma (iStopMM): A nationwide phase 2 trial of patients with smoldering and active multiple myeloma (MM)
Landspitali1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary: Proportion of participants diagnosed with intermediate or high risk SMM that have MRD negativity three year from study enrollment
研究概览
简要总结
This is a phase II study to assess the efficacy of treating patients with intermediate-risk SMM with combinational therapy with dexamethasone and lenalidomide and treating patients with high risk SMM with combinational therapy with dexamethasone, lenalidomide, and carfilzomib. The primary objective is to determine MRD negativity rate at three years after study enrollment.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Active MM or SMM which is untreated
- •Willing to follow strict birth control measures as outlined in the protocol
- •Patients must be willing and able to adhere to the study schedule and other protocol requirement
- •At least 18 years of age, with at least 6 months of expected survival
- •Active MM or SMM (defined as measurable M spike OR pathological FLC ratio AND bone marrow PC% > 10%) which is untreated
- •Laboratory values, see protocol
- •Prior therapy for the treatment of solitary plasmacytoma is permitted, but >7 days should have elapsed from the last day of radiation.
- •Measurable disease as defined by at least ONE of the following: Serum monoclonal protein >1.0 g/L, >200 mg of monoclonal protein in the urine on 24 hour electrophoresis , Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- •ECOG performance status (PS) 0, 1 or 2
- •Provide informed written consent
- •Negative pregnancy test done ≤7 days prior to entry, for women of childbearing potential only
排除标准
- •MGUS or low risk smoldering myeloma
- •Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- •Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol
- •Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products
- •Inability to comply with protocol/procedures
- •Diagnosed or treated for another malignancy ≤ 2 years before trial enrollment or previously diagnosed with another malignancy and have any evidence of residual disease
- •Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception
- •Other co-morbidity which would interfere with subject's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
- •Other concurrent chemotherapy, or any ancillary therapy considered investigational
- •Peripheral neuropathy > Grade 3 on clinical examination or grade 2 with pain within 30 days prior to C1D1
- •Major surgery ≤14 days prior to C1D1
- •Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- •Known human immunodeficiency virus (HIV) positive
结局指标
主要结局
Primary: Proportion of participants diagnosed with intermediate or high risk SMM that have MRD negativity three year from study enrollment
Primary: Proportion of participants diagnosed with intermediate or high risk SMM that have MRD negativity three year from study enrollment
次要结局
- Clinical response by IMWG
- Clinical outcomes by IMWG
- Safety
- Correlation with correlative and clinical outcomes
研究者
Clinical Research Center
Scientific
Landspitali
研究点 (1)
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