The purpose of this study is to test whether daratumumab, a drug that eliminates antibody-producing plasma cells, can effectively lower the level of preformed antibodies in patients awaiting heart transplantation. These preformed antibodies limit the number of donor hearts that are compatible for the patients. If daratumumab can effectively remove preformed, donor-specific antibodies, then highly allosensitized patients will have more compatible hearts available to them, potentially decreasing transplant waitlist time and reducing mortality.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
\>Daratumumab 16 mg/kg intravenous weekly for 8 weeks and then every other week for 2 doses.
Change in the number of individual preformed HLA antibodies before and after daratumumab treatment.
Will compare the number of individual circulating preformed human leukocyte antigen (HLA) antibodies (i.e., those HLA antibodies that have a mean fluorescence intensity \[MFI\] \>3000) at baseline with the number of preformed antibodies after daratumumab treatment.
Time frame: Baseline and Week 12 (or the last measurement prior to heart transplantation, whichever is earlier).
Percent MFI change for each individual preformed HLA antibody after 4 weeks of daratumumab treatment.
Percent change in the MFI of each circulating preformed HLA antibody from baseline to 4 weeks or the time of heart transplantation (whichever is earlier).
Time frame: Baseline and Week 4 (or the last measurement prior to heart transplantation, whichever is earlier).
Percent MFI change for each individual preformed HLA antibody at 8 weeks of daratumumab treatment.
Percent change in the MFI of each circulating preformed HLA antibody from baseline to 8 weeks or the time of heart transplantation (whichever is earlier).
Time frame: Baseline and Week 8 (or the last measurement prior to heart transplantation, whichever is earlier).
Change in the number of individual preformed HLA antibodies after 6 weeks of daratumumab.
Will compare the number of individual circulating preformed HLA antibodies at baseline with the number of preformed antibodies after 6 weeks of daratumumab treatment.
Time frame: Baseline and Week 6 (or the last measurement prior to heart transplantation, whichever is earlier).
Change in the percentage of calculated panel of reactive antibodies before and after daratumumab treatment.
Will compare the serum panel of reactive antibodies (PRA) percentage at baseline with the PRA percentage after 12 weeks of treatment with daratumumab.
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Time frame: Baseline and Week 12 (or the last measurement prior to heart transplantation, whichever is earlier).