NCT01617213终止2 期
Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Event Free Survival
研究概览
简要总结
This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 to 75 years of age.
- •ECOG performance status of 0, 1 or
- •Patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. Patients with basal cell and squamous cell skin cancers are eligible.
- •Patients who are pregnant are ineligible.
- •Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
- •Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.
- •Patients must be HIV and HTLV-I,-II antibody sero-negative.
- •Patients must have adequate visceral organ function
排除标准
- •Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
- •Patients are ineligible if they are receiving any other investigational agents.
研究组 & 干预措施
Maintenance Lenalidomide After Melphalan
Experimental
干预措施: Melphalan (Drug)
Maintenance Lenalidomide After Melphalan
Experimental
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Event Free Survival
时间窗: 3 years
Duration of time until patient experiences an event (recurrence, relapse or death)
次要结局
- Disease Response(2 years)
- Overall survival(4 years)
- Grade > 2 toxicities(4 years)
- Incidence of infections(4 years)
- Treatment related Mortality(4 years)
研究者
Mary Laughlin, MD
Professor, Director of Stem Cell Transplant Program
University of Virginia
研究点 (1)
Loading locations...
相似试验
终止
2 期
Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic LeukemiaNCT00899431M.D. Anderson Cancer Center39
撤回
不适用
Genetically Modified Peripheral Blood Stem Cell Transplant in Treating Patients With HIV-Associated Non-Hodgkin or Hodgkin LymphomaPeripheral T-cell LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaAdult Nasal Type Extranodal NK/T-cell LymphomaAIDS-related Diffuse Large Cell LymphomaAIDS-related Diffuse Mixed Cell LymphomaAIDS-related Diffuse Small Cleaved Cell LymphomaAIDS-related Immunoblastic Large Cell LymphomaAIDS-related Lymphoblastic LymphomaAIDS-related Peripheral/Systemic LymphomaAIDS-related Small Noncleaved Cell LymphomaAngioimmunoblastic T-cell LymphomaCutaneous B-cell Non-Hodgkin LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaHIV-associated Hodgkin LymphomaIntraocular LymphomaNodal Marginal Zone B-cell LymphomaNoncutaneous Extranodal LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRefractory Hairy Cell LeukemiaSmall Intestine LymphomaSplenic Marginal Zone LymphomaStage I AIDS-related LymphomaStage II AIDS-related LymphomaStage III AIDS-related LymphomaStage IV AIDS-related LymphomaT-cell Large Granular Lymphocyte LeukemiaTesticular LymphomaWaldenström MacroglobulinemiaAnaplastic Large Cell LymphomaNCT01769911Fred Hutchinson Cancer Center
已完成
2 期
Modified Bone Marrow Stem Cell Transplantation for Chronic Myelogenous LeukemiaChronic Myeloid LeukemiaGraft vs Host DiseaseNCT00001144National Heart, Lung, and Blood Institute (NHLBI)50
已完成
2 期
Modified Stem Cell Transplantation Procedure for Treating Chronic Granulomatous DiseaseChronic Granulomatous DiseaseNCT00006417National Institute of Allergy and Infectious Diseases (NIAID)10
招募中
不适用
Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCLPeripheral T Cell LymphomaNCT06509945Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine50