JPRN-jRCT2080221988已完成2 期
A PHASE 2, MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF LENALIDOMIDE (CC-5013) IN COMBINATION WITH LOW-DOSE DEXAMETHASONE IN JAPANESE PATIENTS WITH PREVIOUSLY UNTREATED MULTIPLE MYELOMA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
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
- •1) Age >- 20 years at the time of signing the ICD.
- •2) Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted.
- •3) Able to adhere to the study visit schedule and other protocol requirements.
- •4) Previously untreated, symptomatic multiple myeloma diagnostic criteria.
- •5) Have measurable disease by protein electrophoresis analyses.
- •6) At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation.
- •7) ECOG performance status of 0, 1, or 2.
排除标准
- •1) Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •2) Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •3) Any condition that confounds the ability to interpret data from the study.
- •4) Previous treatment with anti-myeloma therapy.
- •5) Pregnant or lactating females.
- •6) Any of the following laboratory abnormalities:
- •-Absolute neutrophil count (ANC) < 1,000/uL (1.0 X 109/L)
- •-Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) < 50,000 cells/uL (50 X 109/L)
- •-Serum SGOT/AST or SGPT/ALT > 3.0 X upper limit of normal
- •7) Renal failure requiring hemodialysis or peritoneal dialysis.
- •8) Prior history of malignancies, other than MM, unless the subject has been free of the disease for >= 5 years.
- •9) Subjects who are unable or unwilling to undergo antithrombotic therapy.
- •10) Peripheral neuropathy of >- grade 2 severity.
- •11) Uncontrolled systemic fungal, bacterial, or viral.
- •12) Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. Known human immunodeficiency virus (HIV) positivity.
- •13) Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
- •14) Ineligible for dexamethasone or dexamethasone is contraindicated.
研究者
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