EUCTR2017-001616-11-DE进行中（未招募）1 期
Elotuzumab (E) in Combination with Carfilzomib, Lenalidomide and Dexamethasone (E-KRd) versus KRd prior to and following Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma and Subsequent Maintenance with Elotuzumab and Lenalidomide versus Single-Agent LenalidomideA phase III study by DSMM (Deutsche Studiengruppe Multiples Myelom)
niversity Hospital Wuerzburg0 个研究点目标入组 576 人开始时间: 2017年12月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 576
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will be enrolled in this study only if they meet all of the following inclusion criteria and none of the exclusion criteria below:
- •1. Adult patients of age = 18 and = 70 years at the time of signing the informed consent form
- •2. Eligible for autologous stem cell transplantation (ASCT)
- •3. Patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma (only dexamethasone at a cumulative dose of 320 mg; plasmapheresis/dialysis without concomitant chemotherapy,
- •local irradiation of bone lesions; and surgical intervention permitted as pretreatment)
- •4. Newly diagnosed multiple myeloma according to the IMWG updated criteria:
- •Clonal bone marrow plasma cells = 10% or biopsy proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:
- •Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
- •- Hypercalcaemia: 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 < 40 mL per min or serum creatinine > 177 µmol/L (> 2 mg/dL)
- •- Anaemia: haemoglobin value of > 2 g/dL below the lower limit of normal, or a haemoglobin value < 10 g/dL
- •- Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or PET-CT
- •Any one or more of the following markers of malignancy:
- •- Clonal bone marrow plasma cell percentage = 60%
- •- Involved: uninvolved serum free light chain ratio = 100, provided the absolute level of the involved light chain is at least 100 mg/L
- •- One or more focal lesions of at least 5mm or greater in size on MRI studies
- •5. Measurable disease parameters as follows:
- •Serum monoclonal paraprotein (M-component) level = 1 g/dL and/or urine M-protein level >200 mg/24 hours or
- •In case of IgA myeloma: Serum monoclonal paraprotein level = 0.5 g/dL and/or urine M-protein level = 200 mg/24 hours
- •For patients with no detectable M-component: Serum FLC assay: Involved FLC level = 10 mg/dL (= 100 mg/L) provided serum FLC ratio is abnormal
- •6. ECOG Performance Status = 2
- •7. Echocardiography with left ventricular ejection fraction (LVEF) = 50%
- •8. Laboratory test results within these ranges:
- •White blood cell count = 2 x 109/L
- •Absolute neutrophil (ANC) count = 1.0 x 109/L
- •Platelet count = 75 x 109/L
- •Haemoglobin > 8 g/dL
- •Calculated creatinine clearance (estimation of the glomerular filtration rate [GFR]; according to MDRD) = 30 mL/minute
- •Total bilirubin = 1.5 x upper limit of normal (ULN)
- •AST and ALT = 2.5 x ULN
- •Corrected serum calcium level < 3.5 mmol/L (< 14 mg/dL)
- •9. Patient’s legal capacity to consent to study participation
- •10. Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study has been obtained.
- •11.All females
- •? Must acknowledge to have understood the hazards lenalidomide can cause to an unborn fetus and the necessary precautions associated with the use of lenalidomide.
- •The investigator must ensure that a FCBP:
- •- Complies with the conditions of the pregnancy prevention plan, including confirmation that she has an adequate level of understanding.
- •- Acknowledges the aforementioned requirements.
- •12. Male subjects must
- •? Understand the potential teratogenic risk if engaged in sexual activity with a pregna
排除标准
- •1. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •2. Waldenström’s macroglobulinemia or IgM myeloma
- •3. Plasma cell leukemia (> 2.0 x 109/L circulating plasma cells by standard differential blood count)
- •4. Pregnant, breast-feeding females, FCBPs and males who are unwilling to comply with the lenalidomide Pregnancy Prevention Risk Management Plan.
- •5. Patients with high cardiovascular risk, including but not limited to history of myocardial infarction or coronary stenting in the past 6 months; NYHA Class III or IV heart failure, uncontrolled angina, uncontrolled hypertension, severe uncontrolled arrhythmias
- •6. Prior cerebral vascular accident (CVA) with persistent neurological deficit
- •7. Active infection
- •8. Known HIV-seropositivity, active or chronic hepatitis A, B, C or Dinfection (including patients who are tested anti-HBC positive and/or HBsAg positive) –serological testing for hepatitis A; B; C, D required. However, testing for hepatitis D only required for patients who tested positive for active acute or chronic hepatitis B.
- •9. Any other severe concomitant disease or disorder, including the presence of laboratory abnormalities, which places the subject at unacceptable risk or which could influence patient’s ability to participate in the study and
- •his/her safety during the study or interfere with interpretation of study results
- •10. Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment
- •11. Major surgery within 4 weeks prior to randomization
- •12. Any systemic anti-myeloma therapy within 4 weeks of randomization except a max. cumulative dose of 320 mg auf dexamethasone.
- •13. Any prior or concurrent malignancy other than multiple myeloma. Exceptions include patients who have been disease-free for at least five years before study entry or patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer
- •14. Known hypersensitivity to carfilzomib, lenalidomide, and elotuzumab or to any of the excipients of carfilzomib, lenalidomide, and elotuzumab or to any other component of any study drug formulation
- •15. Participation in any other clinical trial or treatment with any experimental drug or other experimental therapy within 28 days before enrolment to the study or during study participation until the end of treatment visit
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