The aim of this phase 2 study is to demonstrate that KIR-ligand mismatched haploBMT with post-transplant cyclophosphamide will improve progression free survival in poor risk multiple myeloma patients.
The goal of this study is to evaluate the effectiveness of a new treatment modality, the KIR-ligand mismatched haploidentical stem cell transplantation (haploBMT), for poor risk multiple myeloma (MM) patients. MM is a malignancy of plasma cells that usually resides in the bone marrow. Despite new treatment modalities that have been introduced in the last years, MM is still an incurable disease for most patients and median survival for the younger patients (\<65) is about 5 years. MM can be treated by several disease modifiers - classical chemotherapy, high dose chemotherapy and autologous stem cell transplantation (ASCT), immunomodulators like thalidomide and lenalidomide, and drugs like bortezomib that interact with relevant intracellular pathways of malignant plasma cells. Though these treatment modalities have improved overall survival and quality of life, patients are not cured.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
KIR-mismatched haploidentical Bone Marrow stem cell transplantation
Maastricht university Medical center
Maastricht, Netherlands
RECRUITINGProgression free survival (scale)
Time frame: 1 year
Response rate (scale)
Time frame: analyzed at -7, 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplatation
Incidence of graft failure, engraftment and time to neutrophil and platelet recovery (hematology)
Time frame: 30 days after transplantation
Incidence and Severity of Acute and Chronic GVHD (scale)
Time frame: analyzed during follow-up of 1,5 years
Non-Relapse Mortality (number)
Time frame: 1.5 years
Evaluation of infections after haploBMT and T cell reconstitution (scale)
Time frame: 1 year after transplantation
NK cell repertoire reconstitution and maturation rates including alloreactivity (facs)
Time frame: 1 year after transplantation
NK cell repertoire in the Bone Marrow before and after transplantation (facs)
Time frame: 6 weeks after transplantation
Cost calculation (euro)
Time frame: 1.5 years
Quality of Life (questionnaire)
Time frame: 1.5 years
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