JPRN-jRCTs071180011进行中（未招募）2 期
Evaluation of efficacy and safety of a response adapted therapy adding bortezomib in newly diagnosed, transplant ineligible multiple myeloma patients with insufficient efficacy by lenalidomide - dexamethasone (Rd) therapy. - W-JHS MM01
Shibayama Hirohiko0 个研究点目标入组 80 人开始时间: 2019年1月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Primary enrollment inclusion criteria
- •1) Patients are >= 20 years of age
- •2) Patients who understand the informed consent and can sign the informed consent form by his/her free will.
- •3) Patients who obey the protocol visit and other rules.
- •4) Newly diagnosed multiple myeloma.
- •5) Patients with following measurable M protein by protein electrophoresis analysis
- •6) Patients who cannot carry out hematopoietic stem cells transplantation.
- •7) ECOG PS 0,1 or 2
- •However,PS3 according to bone lesions are eligible.
- •8) Female childbearing patients who meet the following requirements
- •Patients who can agree to receive two times of pregnancy test before study drug administration
- •Patients who can agree to refrain completely from the sex with her partner or be effective contraception measures 28 days before study drug administration, during treatment period and 28 days after discontinuation of study drug administration.
- •9) Male patients who meet the following requirements:
- •Patients who can agree to completely refrains from the sex with his partner. 28days after discontinuation of study drug administration.
- •Patients who agree to not provide a seminal fluid and a sperm during treatment period and 28 days after the discontinuation of study drug administration.
- •10) Patients who meet the following requirements:
- •Understand the risk of teratogenicity of lenalidomide.
- •Can agree to not donate blood during the study drug administration and 28 days after study drug administration.
- •Secondary enrollment inclusion criteria
- •1) MM patients meeting all of the following three definitions.
- •Monoclonal bone marrow plasma cells >=10% or biopsy-proven plasmacytoma
- •Monoclonal protein (M protein) in serum or urine
- •any one or more of the following (1) and (2):
- •(1) Myeloma-related evidence of end organ damage
- •Hypercalcemia,Renal insufficiency,Anemia,Osteolytic lesion or osteoporosis
- •(2) Any one or more of the following definition.
- •60% or greater monoclonal plasma cells on bone marrow examination
- •Serum Free Light Chain >= 100
- •More than 2 focal lesions on MR
排除标准
- •Primary enrollment exclusion criteria
- •1) Patients with severe disorder, laboratory test abnormality, mental disease.
- •2) Patient having a severe disease thought to be exposed to unacceptable risks if he/she participates in the study.
- •3) Patients who are in a state with the possibility to have an influence on the interpretation of the study data.
- •4) Patients with treatment history of myeloma.
- •5) Female patients with pregnancy or nursing.
- •6) Patients with following laboratory test abnormality.
- •Neutrophil < 1000/mm3
- •Platelet before transfusion < 50,000/mm3 (7 days passed after platelet transfusion)
- •AST or ALT > 3 X ULN
- •7) Patients with renal failure needed for hemodialysis or peritoneal dialysis.
- •8) Patients with anamnesis of malignant tumor other than MM
- •9) Patients who are or will not received antithrombotic therapy.
- •10) Patients with grade 2 or more peripheral neuropathy.
- •11) Patients with incontrollable systemic fungal/bacterial/viral infection
- •12) Patients with primary amyloidosis (AL) (immunoglobulin light chain) or myeloma with amyloidosis.
- •13) Patients not receiving dexamethasone or with contraindication of dexamethasone. 14) Patients not receiving bortezomib or with contraindication of bortezomib.
- •Secondary enrollment exclusion criteria
- •1) Patients met exclusion criteria after primary enrollment.
- •2) Patient who are confirmed for human immunodeficiency virus (HIV)-positive or treated.
- •3) Patients with hepatitis B virus (HBs antigen) positive or hepatitis C virus (HCV) antibody positive (if HBc antibody or HBs antibody is positive even if HBs antigen is negative, hepatitis B virus (HBV) DNA test is carried out. If HBV DNA is detected, The patients are excluded)
- •4) Any other patients who are regarded as unsuitable for this study by the investigators
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