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
Washington University School of Medicine
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma per IMWG criteria. * Patient must be in first CR (including CR or sCR) or have PR or VGPR per IMWG criteria. * Patient must be candidate for melphalan and AHCT in the opinion of the treating physician. * At least 18 years of age. * ECOG performance status ≤ 2 * Adequate bone marrow and organ function as defined below: * Total bilirubin ≤ 2 x IULN * AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN * Creatinine clearance ≥ 30 mL/min by Cockcroft-Gault * The effects of CYT107 on the developing human fetus are unknown. For this reason and also…
Interventions
- DrugRecombinant glycosylated human interleukin-7
Provided by RevImmune
- DrugMelphalan
Standard of care
- ProcedureAutologous hematopoietic cell transplant
Standard of care
Location
- Washington University School of MedicineSt Louis, Missouri