Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Eligible for High Dose Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- rate of stringent complete response
研究概览
简要总结
Open-label study to evaluate the safety and efficacy of Ixazomib in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The patient population will consist of adult men and women up to 65 years, who have a confirmed diagnosis of MM who meet eligibility criteria.
详细描述
Patients will receive induction therapy, comprising three cycles with Ixazomib, plus Lenalidomide and Dexamethasone.
Peripheral Blood Stem Cells (PBSC) will be mobilized within 2 weeks (+/- 1 week) after the last dose of Lenalidomide, with Cyclophosphamide plus G-CSF or Granulocyte-CSF(Colony Stimulating Factor).
Intensification: High Dose Melphalan (HDM) will be performed within 3 weeks +/- 1 week following stem cell harvest.
After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase:
Early consolidation (consolidation part 1) will start 2 months after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple myeloma based on the new IMWG Diagnostic Criteria for plasma cells disorders
- •Symptomatic myeloma with CRAB criteria
- •Measurable disease requiring systemic therapy defined by serum M-component ≥ 5g/l or urine M-component ≥ 200 mg/24h or serum FLC ≥ 100 mg/l.
- •Subjects must not have been treated previously with any systemic therapy for multiple myeloma.
- •Eligibility for high dose therapy.
- •Life expectancy ≥ 3 months
- •ECOG performance status 0, 1 or 2
- •Patients must meet the following clinical laboratory criteria:
- •Adequate hepatic function,
- •Absolute neutrophil count (ANC) ≥ 1.0 × 109/L within 14 days prior to enrollment.
- •Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to enrollment
- •Platelet count ≥ 75 × 109/L eRenal eGFR ≥ 50 mL/minute within 7 days
排除标准
- •Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening
- •Evidence of mucosal or internal bleeding and/or platelet refractory.
- •Prior myeloma systemic therapy
- •Major surgery within 14 days before first dose of study drug.
- •Radiotherapy within 14 days before first dose of study drug.
- •Corticosteroids if exceed the equivalent of 160 mg of dexamethasone within 14 days before first dose of study drug
- •Central nervous system involvement
- •Growth factors within 7 days of screening
- •Transfusion within 7 days of screening
- •Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to first dose of study drug
- •Infection .
- •Evidence of current uncontrolled cardiovascular conditions,
- •Systemic treatment, within 14 days before first dose of study drug, with strong inhibitors of CYP1A2 , strong inhibitors of CYP3A or use of Ginkgo biloba or St. John's wort.
- •Ongoing or active systemic infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis and history of hepatitis B or C virus hepatitis.
- •Co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- •Psychiatric illness/social situation that would limit compliance with study requirements.
- •Known allergy to any of the study medications,
- •Contraindication to any of the required concomitant drugs
- •Diagnosed or treated for another malignancy within 5 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease.
- •Patient has significant neuropathy
研究组 & 干预措施
Study treatment
Ixazomib, Lenalidomide, Dexamethasone Induction and extended Consolidation followed by Lenalidomide Maintenance
干预措施: Ixazomib (Drug)
Study treatment
Ixazomib, Lenalidomide, Dexamethasone Induction and extended Consolidation followed by Lenalidomide Maintenance
干预措施: Lenalidomide (Drug)
Study treatment
Ixazomib, Lenalidomide, Dexamethasone Induction and extended Consolidation followed by Lenalidomide Maintenance
干预措施: Dexamethasone (Drug)
结局指标
主要结局
rate of stringent complete response
时间窗: 13 months
after consolidation and before maintenance therapy
次要结局
- overall survival(60 months)
- Correlation between presence of deletion 17p and response rate(60 months)
- Percentage of patients for whom more than 5X106 CD34 cells will be collected.(3 months)
- Correlation between presence of translocation4-14 and response rate(60 months)
- response rates(3 months, 5 months, 7 months, 13 months, 25 months)
- Progression free survival(60 months)
- Adverse events(up 60 Months)