JPRN-UMIN000030974招募中4 期
An Open-label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Ixazomib in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma Initially Treated with an Injection of Proteasome Inhibitor-Based Therapy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- •Treatment Period I
- •1. Men and women of age 20 years or older at the time of enrollment
- •2. Patients with RRMM
- •3. Patients who are planned to start combination therapy with bortezomib, lenalidomide, and dexamethasone (VRd), or combination therapy with carfilzomib, lenalidomide, and dexamethasone (KRd) as second, third or fourth line of treatment
- •4. Patients with measurable disease defined by one or more of the following three measurements
- •-Serum M-protein: >= 1g/dL (>= 10g/L)
- •-Urine M-protein: >= 200mg/24 hours
- •-Serum free light chain assay: involved free light chain concentration >= 10mg/dL (>= 100mg/L) provided that the serum free light chain ratio is abnormal
- •5. Patients with ECOG performance status (PS) 0-2; however, patients with ECOG PS 3 are eligible if they only have symptoms associated with bone lesions.
- •6. Patients who are considered by the principal investigator or investigator not to be eligible for transplant; or, if considered eligible for transplant, patients who are planned not to undergo transplant for at least 12 months after the start of the study treatment
- •7. Patients must be registered with, and comply with, the guidelines of the lenalidomide management program
- •8. Patients who, before implementing procedures related to clinical research (excluding standard medical practices), understand that they can withdraw consent at any time without suffering from disadvantages to future treatments, and can provide written informed consent
- •Treatment Period II
- •9. Patients must have received an injectable proteasome inhibitor (bortezomib or carfilzomib) in each treatment cycle of Treatment Period I
排除标准
- •Treatment Period I
- •1. Patients with another active malignancy
- •2. Patients with poorly controlled active thrombosis
- •3. Patients who have participated in a clinical trial of ixazomib or have been treated with ixazomib
- •4. Patients who were refractory to either treatment regimen based on lenalidomide and/or proteasome inhibitor(s)
- •5. Patients with ongoing or active systemic infection, known hepatitis B virus infection, known hepatitis C virus infection, or known positivity to human immunodeficiency virus (HIV)
- •6. Patients who underwent major surgery within 14 days prior to enrollment to Treatment Period I
- •7. Patients who received radiation therapy within 14 days prior to enrollment to Treatment Period I
- •8. Patients who experience Grade 1 peripheral neuropathy accompanied by pain, or Grade >=2 peripheral neuropathy
- •9. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmia, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months before enrollment to Treatment Period I
- •10. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before enrollment into Treatment Period I
- •11. Patients with central nervous system involvement
- •Treatment Period II
- •12. Patients who do not achieve at least a minimal response (MR) to VRd or KRd in Treatment Period I per the International Myeloma Working Group (IMWG) response criteria, 2014 revision
- •13. Patients who experience Grade 1 peripheral neuropathy accompanied by pain, or Grade >=2 peripheral neuropathy during Treatment Period I
- •14. Patients with evidence of uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmia, symptomatic congestive heart failure, unstable angina, or myocardial infarction during Treatment Period I
- •15. Patients using potent CYP3A4 inducing agents, or gingko biloba or St. John's wort
研究者
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