A randomized, comparative, double-blind trial of pentaisomaltose and dimethyl sulphoxide for cryoprotection of hematopoietic stem cells in subjects with multiple myeloma or malignant lymphoma with a need for autologous transplantation
The trial is a randomized, comparative, double-blind trial comparing the efficacy and safety of pentaisomaltose (PentaHibe®, Pharmacosmos A/S, Holbæk; termed PIM in the following) and dimethyl sulphoxide (DMSO), when used for preservation of harvested hematopoietic stem cells. Approximately 150 subjects with a diagnosis of multiple myeloma or malignant lymphoma (a minimum of 30 % of each diagnosis and an equal distribution in each preservation group) and undergoing autologous stem cell transplantation (ASCT) will be included. The subjects will be randomized 1:1 to receive ASCT preserved in the following cryo-protective agent (CPA): * A: PIM 16 % * B: DMSO 10 %
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Each subject will receive 1 or 2 bags with cryopreserved cells according to randomization group.
Engraftment of hematopoietic stem cells
Incidence of subjects with engraftment of hematopoietic stem cells, defined as 2 consecutive measurements with a neutrophil concentration \>0.5×109/L within the first 19 days after ASCT
Time frame: 19 days
Incidence of subjects with AEs of special interest (limited)
Incidence of subjects with AEs of special interest (limited) occurring within 24 hours after ASCT: headache, nausea, vomiting, bradycardia, or unpleasant odor
Time frame: 24 hours after ASCT
Incidence of subjects with AEs of special interest (limited)
Incidence of subjects with AEs of special interest (limited): headache, nausea, vomiting, bradycardia, or unpleasant odor
Time frame: 19 days
Time to engraftment of neutrophil cells
• Time to engraftment of neutrophil cells, defined as 2 consecutive measurements with a neutrophil concentration \>0.5×109/L within the first 19 days after ASCT
Time frame: 19 days
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