2024-516630-35-01招募中2 期
A MULTICENTER, RANDOMIZED, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (CCyd) as pre transplant INDUCTION and post transplant consolidation or CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (CRd) as pre transplant INDUCTION and post transplant consolidation or continuous treatment with CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (12 cycles) without transplant, all followed by MAINTENANCE with LENALIDOMIDE (R) versus LENALIDOMIDE AND CARFILZOMIB (CR) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 477
- 试验地点
- 40
- 主要终点
- All patients will be included in the Intent-to-Treat (ITT) analysis. Efficacy will be assessed by considering VGPR or better (VGPR, sCR and CR) at cycle 4 in the 3 arms. Assessment of VGPR rate will be performed according to the criteria of the International Myeloma Working Group (Appendix D). To determine the progression-free survival in the 2 maintenance arms.
研究概览
简要总结
To determine the efficacy, in term of at least very good partial response (VGPR), of the combination of Carfilzomib and dexamethasone with cyclophosphamide or lenalidomide after 4 cycles of induction treatment in newly diagnosed MM patients eligible for autologous transplantation (ASCT). To determine the progression-free survival in the 2 maintenance arms.
研究设计
- 分配方式
- Randomized
- 主要目的
- This protocol is a phase II randomized, multicenter study designed to assess safety and efficacy
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years Newly diagnosed MM based on standard CRAB criteria (see appendix B). Patient < 65 years* eligible for ASCT. Patient has measurable disease according to IMWG criteria. Patient has given voluntary written informed consent. Patient agrees to use acceptable methods for contraception. Patient has a Karnofsky performance status ≥ 60% (see appendix G). Pretreatment clinical laboratory values within 30 days of enrollment: Platelet count ≥75 x 109/L (≥50 x 109 /L if myeloma involvement in the bone marrow is > 50%) Absolute neutrophil count (ANC) ≥ 1 x 109/L without the use of growth factors Corrected serum calcium ≤14 mg/dL (3.5 mmol/L) Alanine transaminase (ALT): ≤ 3 x the ULN Aspartate transaminase (AST): ≤ 3 x the ULN Total bilirubin: ≤ 2 x the ULN Calculated or measured creatinine clearance: ≥ 30 mL/minute. LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available *until the day before the 66th birthday Life expectancy ≥ 3 months
排除标准
- •Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid < to the equivalent of dexamethasone 40 mg/day for 4 days) Patients with non-secretory MM unless serum free-light chains are present and the ratio is abnormal or a plasmocytoma with minimum largest diameters of > 2 cm Patients ineligible for autologous transplantation Pregnant or lactating females Presence of: Clinical active infectious hepatitis type A, B, C or HIV Acute active infection requiring antibiotics or infiltrative pulmonary disease Myocardial infarction or unstable angina ≤ 4 months or other clinically significant heart disease Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0 (Appendix A) Known history of allergy to Captisol ® (a cyclodextrin derivative used to solubilize carfilzomib) Contraindication to any of the required drugs or supportive treatments Invasive malignancy within the past 3 years Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the enrollment or place the subject at unacceptable risk.
结局指标
主要结局
All patients will be included in the Intent-to-Treat (ITT) analysis. Efficacy will be assessed by considering VGPR or better (VGPR, sCR and CR) at cycle 4 in the 3 arms. Assessment of VGPR rate will be performed according to the criteria of the International Myeloma Working Group (Appendix D). To determine the progression-free survival in the 2 maintenance arms.
All patients will be included in the Intent-to-Treat (ITT) analysis. Efficacy will be assessed by considering VGPR or better (VGPR, sCR and CR) at cycle 4 in the 3 arms. Assessment of VGPR rate will be performed according to the criteria of the International Myeloma Working Group (Appendix D). To determine the progression-free survival in the 2 maintenance arms.
次要结局
- To determine the stringent complete response (sCR) rate in the 3 arms after complete induction/consolidation therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm) To determine the progression-free survival in in the 3 induction/consolidation arms.
研究者
Clinical Trial Office
Scientific
Universita' Degli Studi Di Torino
研究点 (40)
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