Daratumumab is a human first-in-class monoclonal antibody that targets a cluster of differentiation (CD) 38, a cell surface protein that is overexpressed on multiple myeloma (MM) cells, showing significant activity in relapsed/refractory disease. More recently, it was demonstrated that the addition of daratumumab to pre-autologous hematopoietic stem cell transplant (ASCT) induction regimens in newly diagnosed multiple myeloma increased the rate of complete responses and disease-free survival. However, in consideration of the expression of CD38 antigen also by stem cells, daratumumab could exert effects on their mobilization, collection, and engraftment. The primary objective of this retrospective/prospective observational study is to investigate the impact of adding daratumumab to standard induction regimens (VTD:bortezomib-thalidomide and dexamethasone, VD: bortezomib and dexamethasone) on stem cell mobilization in patients with newly diagnosed multiple myeloma (NDMM) who are candidates for ASCT.
Study Type
OBSERVATIONAL
Enrollment
188
NDMM (newly diagnosed multiple myeloma) who fulfill the inclusion criteria, candidate to stem cell mobilization, collection, and autologous stem cell transplant who receive a Daratumumab-containing induction regimen.
Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, Italy
To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.
To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.
Time frame: 12 months
Proportion (%) of patients achieving at least two minimum transplant doses (4x10^6 CD34+ cells/kg) at first day of apheresis in Daratumumab versus control group.
Proportion (%) of patients achieving at least two minimum transplant doses (4x10\^6 CD34+ cells/kg) at first day of apheresis in Daratumumab versus control group.
Time frame: 12 months
Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.
Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.
Time frame: 12 months
Graft composition in Daratumumab group in term of concentration of CD34+ cells x10^6/kg, TNC (total nucleated cells) x 10^8/kg, and MNC (mononuclear cells) x 10^8/kg.
Graft composition in Daratumumab group in term of concentration of CD34+ cells x10\^6/kg, TNC (total nucleated cells) x 10\^8/kg, and MNC (mononuclear cells) x 10\^8/kg.
Time frame: 12 months
Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.
Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.
Time frame: 12 months
To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.
To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.
Time frame: 12 months
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