Using Interleukin-7 to Improve Immune Recovery in Multiple Myeloma Patients After Transplant
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
This study is testing if a new treatment called interleukin-7 can help multiple myeloma patients recover their immune system better after a stem cell transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | methotrexate, prednisone |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06523699 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of recombinant human interleukin-7 (CYT107) on immune recovery and tumor clearance in patients with multiple myeloma following autologous hematopoietic cell transplant (AHCT). Participants will be randomly assigned to receive either CYT107 alongside standard treatment or standard treatment alone. The goal is to determine if CYT107 can enhance T cell reconstitution, leading to better tumor clearance and fewer infections. The study is conducted at a single site, focusing on safety and efficacy in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed multiple myeloma who are eligible for melphalan and AHCT.
Not a fit: Patients who are not candidates for melphalan and AHCT or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve immune recovery and reduce complications for multiple myeloma patients post-transplant.
How similar studies have performed: While the use of interleukin-7 in this context is novel, similar studies have shown promise in enhancing immune recovery in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 because many alkylating agents such as melphalan are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for one year post-transplant. Should a woman become pregnant or suspect she is pregnant, or a male suspect he has fathered a child during this time frame, s/he must inform the treating physician immediately. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * High doses of corticosteroids (greater than 5 mg prednisone equivalent daily) within 2 weeks of Day -2, with exception of premedication as needed for mobilization regimen. * A history of T-cell malignancy, plasma cell leukemia, or amyloidosis, or history of any other malignancy with the exceptions of in situ carcinomas, non-melanoma skin cancers, and malignancies for which all treatment was completed at least 2 years before Day -2 and the patient has no evidence of disease. * Currently receiving any other investigational agents. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CYT107, melphalan, or other agents used in the study. * Azathioprine, methotrexate, and anti-tumor necrosis factor agents within 2 weeks of Day -2. * A history of congenital immunodeficiency syndrome or autoimmune disease. Patients with autoimmune disorders adequately controlled with medication (5 mg prednisone equivalent or less) are allowed. * A history of clinically-significant pulmonary disorders, such as severe asthma, severe COPD, restrictive lung disease, pulmonary embolism within 3 months prior to study enrollment, or active or prior interstitial lung disease/pneumonitis. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day -2. * Patients without a backup autologous stem cell graft available.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Dilan A Patel, M.D. — Washington University School of Medicine
- Study coordinator: Dilan A Patel, M.D.
- Email: dpatel1@wustl.edu
- Phone: 314-747-8173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.