NCT00327314Unknown2 期
Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
Azienda Ospedaliera San Giovanni Battista2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
研究概览
简要总结
The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.
详细描述
Primary end points are engraftment and non-relapse mortality. Secondary end points are disease response, overall survival, progression and event free survivals. Patient eligibility criteria.
Inclusion criteria included:
- Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
- Age > 18 and ≤ 65 years at the start of the donor search
- Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
- Capacity to give informed consent
Exclusion criteria included:
- Age > 65 years
- Karnofsky performance status score < 60%
- Progressive disease or stable disease for less than three months
- Central nervous system (CNS) involvement
- Left ventricular ejection fraction < 35% or symptomatic heart failure
- Poorly controlled hypertension
- Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
- Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
- HIV positive patients
- Pregnancy
- Refusal to use contraceptive techniques during and for 12 months following treatment
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
- •Age > 18 and ≤ 65 years at the start of the donor search
- •Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
- •Capacity to give informed consent
排除标准
- •Age > 65 years
- •Karnofsky performance status score < 60%
- •Progressive disease or stable disease for less than three months
- •Central nervous system involvement
- •Left ventricular ejection fraction < 35% or symptomatic heart failure
- •Poorly controlled hypertension
- •Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
- •Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
- •HIV positive patients
- •Pregnancy
- •Refusal to use contraceptive techniques during and for 12 months following treatment
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple MyelomaBlood CancerMultiple MyelomaNCT00185614Wen-Kai Weng63
终止
2 期
Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior TreatmentMultiple MyelomaNCT01548573University of Iowa19
已完成
1 期
Combined Bone Marrow Transplantation (BMT) and Renal Transplant for Multiple Myeloma (MM) With End Stage Renal Disease (ESRD)End Stage Renal DiseaseMultiple MyelomaNCT00854139Massachusetts General Hospital10
已完成
1 期
Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell TransplantationAcute Myelogenous LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeNCT00374933Abramson Cancer Center at Penn Medicine18
终止
1 期
Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's DiseaseCrohn's DiseaseNCT01288053Northwestern University9