A Pilot Study of the Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant
Summary
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.
Arms & interventions
- DrugRecombinant glycosylated human interleukin-7
Provided by RevImmune
- DrugMelphalan
Standard of care
- ProcedureAutologous hematopoietic cell transplant
Standard of care
Outcome measures
Primary
Rate 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
Secondary
Rate of minimal residual disease (MRD)
Time frame: At Day 100
Rate of response by IMWG of ≥ complete response (CR)
Time frame: At Day 100
Rate of ≥ grade 3 infections
Time frame: Through day 365
Days from transplant until absolute neutrophil count (ANC) engraftment
Time frame: Through Day 30
Feasibility of treatment schedule
Time frame: 1 month post-transplant (transplant is on Day 0)
Absolute lymphocyte count (ALC) recovery from pre-AHCT
Time frame: Through Day 30
Eligibility criteria
Study locations (1)
Washington University School of Medicine
St Louis, Missouri, 63110