Bortezomib therapy combined with donor lymphocyte infusion in patients with relapsed Multiple Myeloma following allogeneic stem cell transplantation

MC Utrecht, afdeling hematologie0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

Lokhorst HM, Wu K, Verdonck LF et al. The occurrence of graft-versus-host disease is the major predictive factor for response to donor lymphocyte infusions in multiple myeloma. Blood 2004;103:4362-4364. 2. van de Donk NW, Kroger N, Hegenbart U et al. Remarkable activity of novel agents bortezomib and thalidomide in patients not responding to donor lymphocyte infusions following nonmyeloablative allogeneic stem cell transplantation in multiple myeloma. Blood 2006;107:3415-3416. 3. Kroger N, Shimoni A, Zagrivnaja M et al. Low-dose thalidomide and donor lymphocyte infusion as adoptive immunotherapy after allogeneic stem cell transplantation in patients with multiple myeloma. Blood 2004;104:3361-3363. 4.Sun K, Welniak LA, Panoskaltsis-Mortari A et al. Inhibition of acute graft-versus-host disease with retention of graft-versus-tumor effects by the proteasome inhibitor bortezomib. Proc.Natl.Acad.Sci.U.S.A 2004;101:8120-8125

•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

•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.

发起方

MC Utrecht, afdeling hematologie