NCT00349115Unknown2 期
Induction Therapy With TCD Regimen (Thalidomide, Cyclophosphamide, Dexamethasone) Followed by Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
Korean Multiple Myeloma Working Party2 个研究点 分布在 2 个国家目标入组 43 人开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Response rate of TCD induction Therapy
研究概览
简要总结
Multiple Myeloma is a incurable disease. Thalidomide in combination with other agents are currently in trials for the newly diagnosed patients, we designed treatment of TCD, followed by high dose chemotherapy with autologous stem cell transplantation and TD maintenance therapy for the patients with newly diagnosed multiple myeloma.
详细描述
Phase II clinical trial for the patients with newly diagnosed. TCD (thalidomide, cyclophosphamide and dexamethasone) will be applied for the patients as an induction chemotherapy, followed by high dose chemotherpy and autologous stem cell transplantation. Afterthen, they will receive TD (thalidomide and dexamethasone) maintenance therapy for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed multiple myeloma in aged between 18 and 75 years old with following mesurable leisons: (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day) -
排除标准
- •Smoldering or indolent myeloma
- •ECOG performance status > 3 point
- •Known hypersensitivity to cyclphosphamide, thalidomide or dexamethasone
- •Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
- •Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction <0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg
- •Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal)
- •Creatinine cliearance < 20 ml/min
- •Corrected serum calcium ≥ 14 mg/dL
- •Sepsis or current active infection
- •Pregnancy or breast feeding
- •Uncontrolled Diabetes Mellitus
- •Previous history of Recurrent DVT or pulmonary embolism
- •Active ulcers detected by gastroscopy
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •15. Receipt of extensive radiation therapy within 4 weeks
结局指标
主要结局
Response rate of TCD induction Therapy
次要结局
- Progression free survival and Overall survival of TCD, followed by high dose chemotherapy and autoPBSCT and TD maintenance
- To evaluate toxicities of TCD, followed by high dose chemotherapy and autoPBSCT and TD maintenance.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant CandidatesMultiple MyelomaNCT00320476Korean Multiple Myeloma Working Party35
Unknown
3 期
Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple MyelomaMultiple MyelomaNCT02248428Jinling Hospital, China130
Unknown
3 期
VELCADE-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) Incorporated Into Double Autotransplantation for Untreated Multiple Myeloma (MM)Multiple MyelomaNCT01134484Michele Cavo480
已完成
3 期
Thalidomide for Multiple MyelomaMultiple MyelomaNCT00038233M.D. Anderson Cancer Center27
Unknown
2 期
Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular CancerLiver CancerNCT00006198National Center for Research Resources (NCRR)