跳至主要内容
临床试验/ISRCTN53810679
ISRCTN53810679已完成不适用

Bortezomib (Velcade®) therapy combined with Donor Lymphocyte Infusion in patients with relapsed multiple myeloma following allogeneic stem cell transplantatio

niversity Medical Centre Utrecht (UMCU) (The Netherlands)0 个研究点目标入组 20 人开始时间: 2007年5月30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
20

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. Male or female and at least 18 years-of-age;
  • 2. MM patients with any type of relapse or progressive disease following (non) myeloablative allo-SCT for which DLI is considered a treatment option (including patients previously participating in Hovon 54 or Hovon 65 studies);
  • 3. Informed consent;
  • 4. Haematological parameters; Hb > 4.0 mmol/L, leucocytes > 1.0¡Á109/L , thrombocytes > 25 ¡Á109/L, with or without transfusion

排除标准

  • 1. Use of the immunosuppressive drugs cyclosporin, MMF, or corticosteroids;
  • 2. Existing GvHD > grade A;
  • 3. Any non-hematological toxicity CTC grade ¡Ý 3;
  • 4. Neuropathy and/or neuropathic pain CTC grade ¡Ý 2;
  • 5. Pregnancy;
  • 6. History of allergic reaction to compounds containing boron or mannitol;
  • 7. Uncontrolled or severe cardiovascular disease, including myocardial infarctiin within 6 months, NYHA class III of IV heart failure (appendix E), uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis;
  • 8. Previous use of bortezomib is not an exclusion criterion, however patients refractory to bortezomib during previous treatments are excluded from this study.

研究者

发起方
niversity Medical Centre Utrecht (UMCU) (The Netherlands)

相似试验

进行中(未招募)
不适用
Bortezomib in combination with continuous low-dose oral cyclophosphamide and dexamethason followed by maintenance in primary refractory or relapsed bortezomib naïve multiple myeloma patients
EUCTR2008-004822-17-NLniversity Medical Center
已完成
2 期
Bortezomib in combination with continuous low-dose oral cyclophosphamide and dexamethason followed by maintenance in primary refractory or relapsed bortezomib naïve multiple myeloma patientsM. Kahler.10018849Multiple myeloma
NL-OMON38293niversitair Medisch Centrum Groningen73
进行中(未招募)
不适用
Phase II Study of Combination Bortezomib (VELCADE, PS-341), Dexamethasone, and Rituximab (MabThera) (BDR) in Patients with previously untreated Waldenstrom’s Macroglobulinemia (WM). - protocol BDRewly diagnosed Waldenstrom's macroglobulinemia (WM)MedDRA version: 8.1Level: LLTClassification code 10054695Term: Waldenstrom's macroglobulinemia
EUCTR2006-003563-31-NLEuropean Myeloma Network90
进行中(未招募)
不适用
Phase II Study of Combination Bortezomib (VELCADE, PS-341), Dexamethasone, and Rituximab (MabThera) (BDR) in Patients with previously untreated Waldenstrom’s Macroglobulinemia (WM). - protocol BDR
EUCTR2006-003563-31-DKEuropean Myeloma Network90
进行中(未招募)
不适用
Bortezomib re-induction therapy combined with donor lymphocyte infusion in patients with relapsed Multiple Myeloma following allogeneic stem cell transplantatiomultiple myeloma patients with relapse or progression of their disease after receiving an allogeneic stem cell transplantationMedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myeloma
EUCTR2006-005007-34-NLMC20