Xcellerated T CellsTM in Patients With Multiple Myeloma
2005年11月10日 更新者：Xcyte Therapies
A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma
This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy.
15 patients in each study arm will be followed for 6 months.
研究概览
详细说明
This randomized Phase II clinical study is designed to examine the safety and efficacy of Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple myeloma.
Subjects must have failed at least one, but no more than three, prior cytotoxic therapies prior to study registration and may not have relapsed or progressed within one year following hematopoietic stem cell transplantation.
Patients will be randomized to treatment with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine followed by Xcellerated T Cells.
Thirty subjects will be treated, with 15 patients in each arm.
Patients will be followed for six months following treatment.
研究类型
介入性
注册
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Los Angeles、California、美国、90067
- Oncotherapeutics
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San Diego、California、美国、92093
- University of California, San Diego
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San Francisco、California、美国、94143
- University of California, San Francisco
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Maryland
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Baltimore、Maryland、美国、21231
- Johns Hopkins Medical Institute
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Bethesda、Maryland、美国、20817
- Center for Cancer & Blood Disorders
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Missouri
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St. Louis、Missouri、美国、63110
- Washington University School of Medicine
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health Sciences University
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South Carolina
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Greenville、South Carolina、美国、29605
- Cancer Centers of the Carolinas
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
- Previous diagnosis of multiple myeloma (MM) based on standard criteria. Tests need not be performed within 30 days of registration.
- Failure of at least one, but no more than four, prior systemic therapies for MM prior to registration and may not have relapsed or progressed within 1 year following autologous hematopoietic stem cell transplantation. Repeat courses of the same therapeutic regimen separated in time by 6 or more months are considered separate therapies. Induction therapy followed by high dose chemotherapy and autologous hematopoietic stem cell transplantation counts as one therapy.
- Measurable serum and/or urine M-protein
- Disease progression or relapse, since most recent therapy for multiple myeloma
- Age > 18 years old and < 75 years old
- ECOG performance status of 0 or 1
- Females of child-bearing potential must have a negative serum bHCG test and be willing to use effective contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the trial
- Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B, and hepatitis C within 30 days of registration (Antibody, antigen, and nucleic acid tests acceptable, depending on institutional standards)
- Hemoglobin >= 10.0 g/dL. Transfusion with red blood cells or use of erythropoietin is permissible.
- White blood count (WBC) >= 3,000/mm3 and absolute neutrophil count (ANC) > 1000/mm3
- Platelet count > 75,000/mm3
- Corrected serum calcium < 11 mg/dL, and no evidence of symptomatic hypercalcemia. (Corrected serum calcium is calculated by adding 0.8 mg/dL to the measured serum calcium for every 1 g/dL that the serum albumin falls below 4.0 g/dL)
- Serum total bilirubin and alanine aminotransferase (ALT) < 2.0 times the upper limit of normal
- Serum creatinine < 2.5 mg/dL
- Serum human anti-mouse antibody (HAMA) titer undetectable or within the normal range, and no history of allergies to mice or murine (mouse) proteins
- The patient must be able to comprehend and have signed the informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Mark W Frohlich, MD、Xcyte Therapies
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年11月1日
研究完成
2004年6月1日
研究注册日期
首次提交
2004年2月18日
首先提交符合 QC 标准的
2004年2月19日
首次发布 (估计)
2004年2月20日
研究记录更新
最后更新发布 (估计)
2005年11月11日
上次提交的符合 QC 标准的更新
2005年11月10日
最后验证
2005年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Xcellerated T 细胞的临床试验
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Universidad de la SabanaFundación Neumologica Colombiana; Stem Medicina Regenerativa; Innocell SAS可用的
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The First Affiliated Hospital of Soochow UniversityFundamenta Therapeutics, Ltd.招聘中
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Yan JinXijing Hospital; Tang-Du Hospital未知
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Medical College of WisconsinChildren's Hospital and Health System Foundation, Wisconsin招聘中急性淋巴细胞白血病 | 急性淋巴细胞白血病，儿科 | 急性淋巴细胞白血病，复发 | 急性淋巴细胞白血病复发 | 缓解失败的急性淋巴细胞白血病 | 急性淋巴细胞白血病未达到缓解美国