Multiple Myeloma Clinical Trial
Official title:
Impact of Different DMSO Concentrations in Cryopreservation Mixture on Hematopoietic Recovery After Autologous Transplantation of Hematopoietic Stem Cells.
The main aim of the study was to evaluate the clinical impact of different DMSO concentrations in cryopreservation mixture (5%, 7.5%, 10%) on reconstitution of hematopoiesis after autologous hematopoietic stem cell transplantation.
The procedure of autologous hematopoietic stem cell (HSC) transplantation requires
cryopreservation of HSCs. Addition of DMSO (dimethyl sulfoxide) is necessary to secure the
viability of such cells, but this cryoprotectant is potentially toxic to stem cell
recipient. The concentrations of DMSO in cryopreservation mixture vary strongly between
protocols in different transplant centers. Usually, the HSCs are stored in mixtures
containing 10% DMSO, but there is no sufficient evidence that this concentration of DMSO is
indeed optimal.
The main aim of the study is to evaluate the clinical impact of reduction of DMSO
concentration in cryopreservation mixture on engraftment after autologous hematopoietic stem
cell transplantation. 150 consecutive patients will be randomly assigned to one of three
study arms (50 patients each). HSCs obtained by leukapheresis will be cryopreserved in three
concentrations of DMSO: 5%, 7.5%, 10%, respectively. Evaluation of the mixtures will be
carried out by monitoring reconstitution of hematopoiesis and the frequency the side effects
in patients. The most important aspect of our evaluation will be the speed of neutrophil
recovery after transplantation (defined by the first day, when absolute neutrophil count in
peripheral blood will be higher than 0.5 G/L). The investigators will also evaluate the
toxicity of cell suspension by monitoring the frequency of infusion-related adverse events
(like nausea or vomiting) during infusion and 24 hours after transplantation.
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