Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma
RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.
研究概览
地位
详细说明
OBJECTIVES:
- Determine whether autologous peripheral blood stem cell transplantation (PBSCT) followed by non-myeloablative allogeneic PBSCT is associated with no more than 20% treatment-related mortality rates at 6 months in patients with multiple myeloma.
- Determine the response rate of patients treated with this regimen.
- Determine the percent donor chimerism in patients treated with this regimen.
- Determine the rate of graft-vs-host disease in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell (PBSC) collection is complete.
Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30 minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0. Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover.
Approximately 2-4 months after autologous PBSCT, patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3. Patients undergo allogeneic PBSCT on day 0. Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover.
Patients receive graft-vs-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1, 3, and 6.
After day 120, patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion (DLI) over 2 hours. Patients may receive up to 3 DLIs every 8 weeks.
Patients are followed every 3 months for 3 years, every 6 months for 5 years, and then annually for 15 years.
PROJECTED ACCRUAL: A maximum of 63 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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California
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San Francisco、California、美国、94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Delaware
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Lewes、Delaware、美国、19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark、Delaware、美国、19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington、District of Columbia、美国、20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Illinois
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Chicago、Illinois、美国、60637-1470
- University of Chicago Cancer Research Center
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Iowa
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Iowa City、Iowa、美国、52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Maryland
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Elkton MD、Maryland、美国、21921
- Union Hospital Cancer Program at Union Hospital
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Missouri
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St Louis、Missouri、美国、63110
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
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New Jersey
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Voorhees、New Jersey、美国、08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Buffalo、New York、美国、14263-0001
- Roswell Park Cancer Institute
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New York、New York、美国、10029
- Mount Sinai Medical Center
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North Carolina
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Chapel Hill、North Carolina、美国、27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Winston-Salem、North Carolina、美国、27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Columbus、Ohio、美国、43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Diagnosis of active multiple myeloma that requires treatment
- Durie-Salmon stage I, II, and III
- No more than 1 progression after initial therapy
Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR)
- No syngeneic donors
- Must also be enrolled on protocol CLB-8461 (Cytogenetic Studies in Acute Leukemia)
PATIENT CHARACTERISTICS:
Age:
- Under 65
Performance status:
- NCI CTC 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 500/mm^3
- Platelet count greater than 50,000/mm^3
Hepatic:
- Bilirubin less than 2 mg/dL
- AST less than 3 times upper limit of normal (ULN)
- Alkaline phosphatase less than 3 times ULN
Renal:
- Creatinine less than 2 mg/dL
- Creatinine clearance greater than 40 mL/min
Cardiovascular:
- LVEF at least 30% by MUGA scan
Pulmonary:
- DLCO greater than 40% of predicted
- No symptomatic pulmonary disease
Other:
- HIV negative
- No uncontrolled diabetes mellitus
- No active serious infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- Prior alkylating-agent therapy allowed if no more than 12 months duration
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- At least 4 weeks since prior surgery
Other:
- All prior therapy no more than 18 months duration
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
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PBSC collection: 10 ug/kg/d subQ inj D 5 until completion of collection Auto transpl: 5 ug/kg/d subQ inj D 5 until ANC >= 1500/uL for 2d or 5000/uL for 1 d Allo transpl: 5ug/kg/d subQ inj D 7 until ANC > 1000/uL for 3 days Donor pheresis: 10ug/kg/d subQ inj d -5 thru -2
其他名称：
2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant
4g/sq m IV infusion over 1-2 hrs D 1 for auto, and 1g/sq m/d IV infusion over 1 hr on D -4 thru -3 for allo, transplant prep
30mg/sq m/d IVPB over 30 min d -7 thru -3 allo transpl
200mg/sq m IV infusion over 15-30 min D 2 auto transpl
5mg/sq m/d IV infusion D 1,3,& 6: allo transpl
0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Treatment-related mortality
大体时间：6 months
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment Completion Rate
大体时间：post treatment
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post treatment
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Respone Rate
大体时间：2-4 wks prior, and 3,6 mon then q 3 mon for 3 yrs, post allo transpl, then q 6 mon for max 15 yrs from study entry
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2-4 wks prior, and 3,6 mon then q 3 mon for 3 yrs, post allo transpl, then q 6 mon for max 15 yrs from study entry
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Chimerism Rate
大体时间：1,2,3,4, & 6 mon post allo transpl, & 100 d post DLI
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1,2,3,4, & 6 mon post allo transpl, & 100 d post DLI
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GVHD Incidence
大体时间：post allo transpl, & pre & post DLI
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post allo transpl, & pre & post DLI
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Survival
大体时间：2 years
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Overall and disease free survival will be assessed
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2 years
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Correlation of cytogenetics and response
大体时间：6, 12 mon then q 1 yr for 3 yrs post allo transpl
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6, 12 mon then q 1 yr for 3 yrs post allo transpl
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合作者和调查者
调查人员
- 学习椅：Kenneth C. Anderson, MD、Dana-Farber Cancer Institute
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CALGB-100001
- U10CA031946 (美国 NIH 拨款/合同)
- CDR0000069109 (注册表标识符：NCI Physician Data Query)
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.
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