Actively Recruiting
Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant
Led by Washington University School of Medicine · Updated on 2025-08-28
30
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
R
Revimmune
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of multiple myeloma per IMWG criteria
- Patient must be in first complete response (CR or sCR), partial response (PR), or very good partial response (VGPR) per IMWG criteria
- Candidate for melphalan chemotherapy and autologous hematopoietic cell transplant as determined by treating physician
- At least 18 years of age
- ECOG performance status of 2 or less
- Adequate organ and bone marrow function: total bilirubin ≤ 2 times upper limit of normal, AST/ALT ≤ 2.5 times upper limit of normal, creatinine clearance ≥ 30 mL/min by Cockcroft-Gault
- Willingness to use effective contraception before study and for one year after transplant if of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Use of high-dose corticosteroids (>5 mg prednisone equivalent daily) within 2 weeks before Day -2, except for premedication during mobilization
- History of T-cell malignancy, plasma cell leukemia, amyloidosis, or other malignancies except certain skin cancers or those treated with no disease for 2 years before Day -2
- Currently receiving other investigational drugs
- History of allergic reactions to CYT107, melphalan, or similar compounds
- Use of azathioprine, methotrexate, or anti-TNF agents within 2 weeks before Day -2
- History of congenital immunodeficiency or autoimmune disease, except controlled autoimmune disorders with ≤5 mg prednisone equivalent
- History of serious lung diseases such as severe asthma, COPD, pulmonary embolism within 3 months, or interstitial lung disease
- Uncontrolled illnesses including active infections, heart failure, unstable angina, or arrhythmias
- Pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test within 7 days before Day -2
- No backup autologous stem cell graft available
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
D
Dilan A Patel, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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