Multiple Myeloma/ Multiple Myeloom/ Morbus Kahler Allogeneic stem cell transplantation/allogene stamceltransplantatie Donor lymphocyte infusion/Donor lymfocyten infusie Bortezomib
Conditions
Interventions
The intervention consists of a sequential approach over bortezomib cycli (2) with DLI. The bortezemib cycli are given before and 2 weeks after the DLI infusion. If the patient reaches a CR the treatme
Sponsors
UMC Utrecht, afdeling hematologie
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is response rate. The included patients will be analysed with analysis of the m-protein at entry, after bortezomib cycle 2, 4, 6, 8 and before administration of DLI or before cycle 4,6,8 if no more DLI is given. After each DLI before administration of bortezomib cycle 3, 5, 7 and in follow up every 2 months. Bone marrow examination will be done on indication, for example confirmation of CR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are evaluated at the same time points as the primary outcome. Blood samples for experimental mmunology are taken before first gift bortezomib in cycle 1, before first DLI, before first gift bortezomib cycle 3, before DLI nr 2, before first gift bortezomib cycle 5, before DLI nr 3, before first gift bortezomib cycle 7 and by stopping treatment and/or by occurring GvHD. | — |
Contacts
Public ContactM.C. Minnema
University Medical Center Utrecht Department of Hematology/B02.226 P.O. Box 85500
Outcome results
None listed