EUCTR2014-003079-40-DE进行中（未招募）1 期
A randomized phase III trial on the effect of elotuzumab in VRD induction /consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma - GMMG-HD6
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by University Hospital Heidelberg0 个研究点目标入组 564 人开始时间: 2014年10月16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
- 564
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
- •- Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (updated IMWG criteria for diagnosis of MM, 2014)
- •- Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:
- •Serum M-protein = 10g/l (for IgA = 5g/l)
- •Urine light-chain (M-protein) of = 200 mg/24 hours
- •Serum FLC assay: involved FLC level = 10 mg/dl provided sFLC ratio is abnormal
- •- Age 18 - 70 years inclusive
- •- WHO performance status 0-3 (WHO=3 is allowed only if caused by MM and not by comorbid conditions)
- •- Negative pregnancy test at inclusion (women of childbearing potential)
- •- For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy. Patients must agree on the requirements regarding the lenalidomide pregnancy prevention programme described in
- •chapter 6.
- •- All patients must
- •agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy
- •agree not to share study drug lenalidomide with another person and to return all unused study drug to the investigator or pharmacist
- •- Ability of patient to understand character and individual consequences of the clinical trial
- •- Written informed consent (must be available before enrollment in the trial)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 424
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •- Patient has known hypersensitivity to any drugs given in the protocol, notably bortezomib, lenalidomide, dexamethasone and elotuzumab or to any of the constituent compounds.
- •- Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
- •- Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression.
- •- Severe cardiac dysfunction
- •- Significant hepatic dysfunction
- •- Patients with renal insufficiency requiring hemodialysis
- •- HIV-positivity
- •- Patients with active or history of Hepatitis B or C
- •- Patients with active, uncontrolled infections
- •- Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0)
- •- Patients with a history of active malignancy during the past 5 years with the exception of basal cell carcinoma of the skin or stage 0 cervical carcinoma treated with curative intent
- •- Platelet count < 75 x 10^9/l, or, dependent on bone marrow infiltration by plasma cells, platelet count < 30 x 10^9/l
- •- Haemoglobin < 8.0 g/dl, unless related to myeloma
- •- Absolute neutrophil count (ANC) < 1.0 x 10^9/l
研究者
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