Interleukin-7 for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial requires that you stop taking high doses of corticosteroids and certain medications like azathioprine, methotrexate, and anti-tumor necrosis factor agents at least 2 weeks before starting the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
How does the treatment Interleukin-7 differ from other treatments for multiple myeloma?
Interleukin-7 (IL-7) is unique because it is a cytokine (a type of protein important for cell signaling) that can enhance the immune system's ability to fight cancer by promoting the growth and survival of T-cells, which are crucial for immune responses. This mechanism is different from other treatments that may focus on directly targeting cancer cells or inhibiting specific pathways involved in cancer cell proliferation.12345
Research Team
Dilan A Patel, M.D.
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for multiple myeloma patients who are undergoing autologous hematopoietic cell transplant. Participants must meet certain health standards, but specific inclusion and exclusion criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT). In the experimental arm, CYT107 is administered subcutaneously starting on Day 1, with two doses in the first week and weekly for 3 more weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments for minimal residual disease and response rates.
Long-term follow-up
Monitoring for non-hematologic grade ≥3 CYT107 treatment-related adverse events.
Treatment Details
Interventions
- Recombinant Human Interleukin-7 (CYT107)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Revimmune
Industry Sponsor