ISRCTN82155239已完成不适用
Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 452 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 452
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Previously untreated multiple myeloma, stage 2 or 3 according to Salmon and Durie
- •2. Aged less than 66 years
- •3. World Health Organization (WHO) performance status 0 - 3
- •4. Informed consent
- •For Interferon (IFN) maintenance and Peripheral Blood Stem Cell Transplant (PBSCT) or Allogeneic Bone Marrow Transplant (ABMT):
- •1. At least Partial Remission (PR) after induction therapy
- •2. WHO performance status 0 - 2
- •3. Suitable peripheral stem or bone marrow graft
- •4. No active infections
- •5. Absence of severe cardiac, pulmonary, neurologic, psychiatric disease
- •6. Serum creatinine, bilirubin and transaminases of less than 2.5 x upper limit of normal values
- •7. Platelet count greater than 50 x 10^9/l
- •8. Absolute neutrophil count greater than 1 x 10^9/l
- •9. Informed consent
排除标准
- •1. Received more than 2 courses of melphalan, prednisone or vincristine, melphalan (M), cyclophosphamide, prednisone (VMCP)
- •2. Severe cardiac disease (= severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45% with presence of normal hemoglobin), severe pulmonary, neurologic or metabolic disease- Inadequate liver function, i.e., bilirubin greater than or equal to 25 x upper normal value
- •3. Prior malignancies except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
- •4. Prior extensive radiotherapy involving the myelum (precluding total body irradiation)
研究者
相似试验
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Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma.Multiple myeloma.NL-OMON20547Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl452
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Autologous and Allogeneic Transplant for Relapsed LymphomaNon-Hodgkin's LymphomaHodgkins DiseaseNCT00802113Columbia University30
进行中（未招募）
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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）
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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