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CYT107 + Melphalan + AHCT for Multiple Myeloma

Phase 1
Waitlist Available
Led By Dilan A Patel, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Histologically confirmed diagnosis of multiple myeloma.
* Patient must be in first CR (including CR or sCR) or have PR or VGPR per IMWG criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 365
Awards & highlights

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of CYT107 may include reactions at the injection site, flu-like symptoms, bone pain, fatigue, headache, or rash. Melphalan can cause nausea, mouth sores, diarrhea, low blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of non-hematologic grade ≥3 treatment-related AEs (excluding expected transplant-related AEs) according to CTCAE v5
Secondary study objectives
Absolute lymphocyte count (ALC) recovery from pre-AHCT
Days from transplant until absolute neutrophil count (ANC) engraftment
Feasibility of treatment schedule
+3 more

Trial Design

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Autologous hematopoietic cell transplant
2017
N/A
~750

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,962 Previous Clinical Trials
2,312,632 Total Patients Enrolled
33 Trials studying Multiple Myeloma
2,237 Patients Enrolled for Multiple Myeloma
RevimmuneIndustry Sponsor
10 Previous Clinical Trials
181 Total Patients Enrolled
Dilan A Patel, M.D.Principal InvestigatorWashington University School of Medicine
~20 spots leftby Oct 2028
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