30 Participants Needed

Interleukin-7 for Multiple Myeloma

DA
Overseen ByDilan A Patel, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

DA

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

I can understand and am willing to sign a consent form.
My doctor thinks I am a good candidate for melphalan and stem cell transplant.
My cancer is responding well to treatment.
See 4 more

Exclusion Criteria

I haven't taken high doses of steroids in the last 2 weeks.
I am allergic to medications similar to CYT107, melphalan, or others in the study.
Currently receiving any other investigational agents
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

4 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for minimal residual disease and response rates.

100 days

Long-term follow-up

Monitoring for non-hematologic grade ≥3 CYT107 treatment-related adverse events.

365 days

Treatment Details

Interventions

  • Recombinant Human Interleukin-7 (CYT107)
Trial Overview The study compares two groups: one receiving standard care with melphalan and a stem cell transplant, and the other adding CYT107 to this regimen. The goal is to see if CYT107 improves immune system recovery and helps clear cancer cells more effectively.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: CYT107 + Melphalan + AHCTExperimental Treatment3 Interventions
All patients on this protocol will be treated with standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT). After AHCT, if patients are randomized to the experimental arm, CYT107 will be initiated and will continue for 4 weeks. CYT107 will be administered subcutaneously starting on D+1. Two doses will be given during the first week, and then CYT107 will be administered weekly for 3 more weeks for a total of 5 doses.
Group II: Melphalan + AHCTActive Control2 Interventions
All patients on this protocol will be treated with standard of care melphalan conditioning followed by autologous hematopoietic stem cell transplant (AHCT).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Revimmune

Industry Sponsor

Trials
11
Recruited
210+

References

Interleukin-6 leads to interleukin-10 production in several human multiple myeloma cell lines. Does interleukin-10 enhance the proliferation of these cells? [2013]
High level of interleukin-10 in serum predicts poor prognosis in multiple myeloma. [2022]
Circulating IL-6-type cytokines and sIL-6R in patients with multiple myeloma. [2006]
4.Czech Republicpubmed.ncbi.nlm.nih.gov
[The cytokine network in multiple myeloma]. [2006]
Eliciting protective immune responses against murine myeloma challenge in lymphopenia mice through adoptive transfer of tumor antigen-specific lymphocytes and immunization of tumor vaccine secreting mIL-21. [2018]
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