跳至主要内容
临床试验/NCT00349778
NCT00349778已完成2 期

High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

Stanford University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
102
试验地点
1
主要终点
Number of Participants With Pulmonary Toxicity

研究概览

简要总结

This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.

详细描述

Analysis of 196 previously treated patients demonstrated a median event-free survival (EFS) of 36 months with a median overall survival of more than 6 years. The main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of carmustine. Institutional experience in myeloma patients using this dose of carmustine indicates an incidence of IP of34%.

There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma. These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill, decreased tumor burden and an improvement in overall survival. Our results with high-dose sequential therapy including the dose-intense carmustine/melphalan transplant demonstrates similar median EFS and overall survival (OS) when compared with the results of tandem transplant approaches.The proposed trial will continue to use a high-dose sequential transplant approach, however, we will use a reduced dose of carmustine which we expect to be associated with a lower incidence of IP.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

High-Dose Sequential Therapy

Experimental

Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim

干预措施: Cyclophosphamide (Drug)

High-Dose Sequential Therapy

Experimental

Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim

干预措施: Etoposide (Drug)

High-Dose Sequential Therapy

Experimental

Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim

干预措施: Melphalan (Drug)

High-Dose Sequential Therapy

Experimental

Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim

干预措施: Carmustine (Drug)

High-Dose Sequential Therapy

Experimental

Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim

干预措施: Filgrastim (Drug)

结局指标

主要结局

Number of Participants With Pulmonary Toxicity

时间窗: 2 years

Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.

次要结局

  • Overall Participant Survival (OS)(5 years)
  • Number of Participants That Relapse After Autologous Transplantation(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sally Arai

Assistant Professor of Medicine

Stanford University

研究点 (1)

Loading locations...

相似试验

已完成
3 期
Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple MyelomaAuto Stem Cell TransplantMultiple Myeloma
NCT01241708Hackensack Meridian Health148
Unknown
2 期
Tandem High Dose Chemotherapy and Autologous Stem Cell Rescue for High Risk Pediatric Brain TumorsBrain Tumors
NCT01342237Seoul National University Hospital33
进行中(未招募)
1 期
High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma -randomized phase III trialPrimary CNS lymphoma (PCNSL) accounts for 1 to 2% of all Non-Hodgkin's lymphomas (NHL) and for 2 to 7% of all primary CNS tumors.It's incidence has increased over the past 30 years, particularly in immunocompetent individuals. Over 90% of PCNSL are lymphomas of Bcell origin, accounting to the subtype diffuse large B-cell lymphoma.(DLBCL). Prognosis without treatment resembles that of systemic highgrade NHL, and the median survival of untreated patients with PCNSL is approximately 3 months.MedDRA version: 21.0Level: PTClassification code 10007953Term: Central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2012-000620-17-ITCITY OF STUTTGART, REPRESENTED BY KLINIKUM STUTTGART250
进行中(未招募)
1 期
In the presently planned multicentre Phase III trial the two therapies will be compared: Patients will be randomized after intensified induction treatment with 4 cycles rituximab, methotrexate, cytarabine and thiotepa (MATRix) between first-line high-dose chemotherapy against conventional consolidating therapy with 2 cycles of conventional chemotherapy with R-DeVIC (Rituximab, Dexamthason, Etoposide, Ifosfamide, Carboplatin).Primary CNS lymphoma (PCNSL) accounts for 1 to 2% of all Non-Hodgkin's lymphomas (NHL) and for 2 to 7% of all primary CNS tumors. It's incidence has increased over the past 30 years, particularly in immunocompetent individuals. Over 90% of PCNSL are lymphomas of B-cell origin, accounting to the subtype diffuse large B-cell lymphoma. (DLBCL). Prognosis without treatment resembles that of systemic high-grade NHL, and the median survival of untreated patients with PCNSL is approximately 3 months.
EUCTR2012-000620-17-DEandeshauptstadt Stuttgart, represented by the Executive Medical Director Klinikum Stuttgart330
进行中(未招募)
1 期
In the presently planned multicentre Phase III trial the two therapies will be compared: Patients will be randomized after intensified induction treatment with 4 cycles rituximab, methotrexate, cytarabine and thiotepa (MATRix) between first-line high-dose chemotherapy against conventional consolidating therapy with 2 cycles of conventional chemotherapy with R-DeVIC (Rituximab, Dexamthason, Etoposide, Ifosfamide, Carboplatin).Primary CNS lymphoma (PCNSL) accounts for 1 to 2% of all Non-Hodgkin's lymphomas (NHL) and for 2 to 7% of all primary CNS tumors. It's incidence has increased over the past 30 years, particularly in immunocompetent individuals. Over 90% of PCNSL are lymphomas of B-cell origin, accounting to the subtype diffuse large B-cell lymphoma. (DLBCL). Prognosis without treatment resembles that of systemic high-grade NHL, and the median survival of untreated patients with PCNSL is approximately 3 months.MedDRA version: 19.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
EUCTR2012-000620-17-NOandeshauptstadt Stuttgart, represented by Prof. Dr. J. Graf, Leitender Aerztlicher Direktor Klinikum Stuttgart346