This is a two-arm, open-label, randomized, single-site, pilot study testing the addition of CYT107 following autologous hematopoietic cell transplant (AHCT) in patients with multiple myeloma (MM). The hypothesis of this study is that recombinant human CYT107 can be safely administered after AHCT and will promote quantitative and qualitative T cell reconstitution, which will be associated with enhanced tumor cell clearance and reduced infectious complications. Patients will be randomized to either the intervention arm that will receive CYT107 + standard of care melphalan and AHCT or to the control arm that will receive standard of care melphalan and AHCT only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Provided by RevImmune
Standard of care
Standard of care
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGRate of non-hematologic grade ≥3 CYT107 treatment-related AEs (excluding expected transplant-related AEs or AEs attributed to melphalan and ASCT) according to CTCAE v5
Treatment-related AEs will be defined as AEs occurring that are at least possibly related to the CYT107 treatment, or the combination of melphalan, AHCT, and CYT107.
Time frame: Through day 365
Rate of minimal residual disease (MRD)
For the purposes of this study, a patient will be considered as having minimal residual diseases if a positive result (per 10-5 threshold) is obtained using the Adaptive Clonoseq MRD testing.
Time frame: At Day 100
Rate of response by IMWG of ≥ complete response (CR)
* Stringent complete response (sCR): * CR as defined below * Normal free light chain ratio (0.26-1.65) * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence * Complete response (CR): * Negative immunofixation on the serum and urine * \<5% plasma cells in the bone marrow aspirate * Disappearance of any soft tissue plasmacytomas
Time frame: At Day 100
Rate of ≥ grade 3 infections
Time frame: Through day 365
Days from transplant until absolute neutrophil count (ANC) engraftment
Neutrophil engraftment is defined as the first day of 3 consecutive days of ANC ≥ 500 following the post-transplant nadir.
Time frame: Through Day 30
Feasibility of treatment schedule
The study will be feasible if 20% of patients are able to receive all 5 doses of CYT107 within the first month post-transplant.
Time frame: 1 month post-transplant (transplant is on Day 0)
Absolute lymphocyte count (ALC) recovery from pre-AHCT
Time frame: Through Day 30
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