NCT00366106终止2 期
A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma
Accelerated Community Oncology Research Network30 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2006年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 30
- 主要终点
- Incidence of Treatment-emergent Peripheral Neuropathy
研究概览
简要总结
The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years of age.
- •Patient has confirmed diagnosis of relapsed/refractory multiple myeloma with measurable disease by serum or urine. Measurable disease defined as monoclonal protein of ≥ 1g/dl on serum protein electrophoresis (SPEP) or > 200 mg urine M protein/ 24 hours
- •Patient has received at least 1 prior treatment regimen. (Prior treatment with bortezomib is allowed.)
- •Patient has ECOG ≤ 2
- •Patient provides voluntary written informed consent before performance of any study-relates procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- •Patients who have received prior high dose chemotherapy with stem cell support are eligible for this study.
- •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- •Male subject agrees to use an acceptable method for contraception for the duration of the study.
排除标准
- •Patient has a platelet count of < 50, 000 cells/mm³, within 14 days before enrollment.
- •Patient has an absolute neutrophil count (ANC) ≤ 750/mm³ within 14 days before enrollment.
- •Patient has a calculated or measured creatinine clearance of < 20 mL/min within 14 days before enrollment and/or serum creatinine ≥ 2.5 mg/dl.
- •Patient has hemoglobin < 7.5 g/dl.
- •Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- •Myocardial infarction within 6 months prior to enrollment or has (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant.
- •Patient has received a total cumulative dosage of anthracyclines exceeding 550 mg/m
- •Patient has hypersensitivity to boron or mannitol.
- •Patient has history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL.
- •Patient has clinically significant coexisting illness unrelated to myeloma.
- •Patient has uncontrolled diabetes.
- •Patient has plasma cell leukemia.
- •Patient has serum bilirubin > 1.5 x upper normal limit, alanine aminotransaminase (ALT), aspartate aminotransferase (AST) > 2.5 x upper normal limit (ULN), or alkaline phosphatase > 2.5 x ULN.
- •Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG)pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- •Patient has received other investigational drugs within 14 days before enrollment.
- •Patient has serious medical or psychiatric illness likely to interfere with participation in this clinical study.
结局指标
主要结局
Incidence of Treatment-emergent Peripheral Neuropathy
时间窗: Every 4 weeks from start of treatment until end of treatment
次要结局
- Time to Progression (TTP)(TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months)
- Number of Participants With Treatment Response(Every 8 weeks from start of treatment until end of treatment)
- Relative Dose Intensity of Bortezomib(Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days))
研究者
研究点 (30)
Loading locations...
相似试验
进行中（未招募）
2 期
PMT for MDRO DecolonizationMultidrug Resistant Bacterial InfectionEnterobacteriaceae InfectionsPseudomonas AeruginosaVRE InfectionMethicillin-resistant Staphylococcus AureusNCT05632315University of Pennsylvania32
已完成
1 期
Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse EventsSubmental FatNCT05476679Raziel Therapeutics Ltd.48
招募中
2 期
A Study of AT-02 in Subjects With Systemic Amyloidosis.Systemic AmyloidosisNCT05951049Attralus, Inc.120
已完成
2 期
Efficacy and Tolerability of ZD6474 in Patients With Thyroid CancerThyroid CancerNCT00098345Genzyme, a Sanofi Company40
进行中（未招募）
不适用
Estudio abierto de fase II para evaluar los posibles marcadores tumorales predictivos en pacientes con cáncer colorrectal metastásico y tumor con KRAS no mutado tratados con FOLFOX6m y panitumumab como tratamiento de primera línea.Pacientes con cáncer colorrectal metastásico y tumor con KRAS no mutado tratados con FOLFOX6m y Panitumumab como tratamiento de primera líneaEUCTR2009-017331-18-ESGrupo Español Multidisciplinar en Cáncer Digestivo-GEMCAD