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Trial Title:
Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant
NCT ID:
NCT06523699
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Melphalan
Conditions: Keywords:
Myeloma
Immune reconstitution
IL-7
Cytokine
Autologous
Transplant
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized 2:1 to receive CYT107 + standard of care melphalan and AHCT or standard of
care melphalan and AHCT alone.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Recombinant glycosylated human interleukin-7
Description:
Provided by RevImmune
Arm group label:
CYT107 + Melphalan + AHCT
Other name:
CYT107
Other name:
r-hIL-7
Intervention type:
Drug
Intervention name:
Melphalan
Description:
Standard of care
Arm group label:
CYT107 + Melphalan + AHCT
Arm group label:
Melphalan + AHCT
Intervention type:
Procedure
Intervention name:
Autologous hematopoietic cell transplant
Description:
Standard of care
Arm group label:
CYT107 + Melphalan + AHCT
Arm group label:
Melphalan + AHCT
Other name:
AHCT
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of multiple myeloma.
- 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.
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Contact:
Last name:
Dilan A Patel, M.D.
Phone:
314-747-8173
Email:
dpatel1@wustl.edu
Investigator:
Last name:
Dilan Patel, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Michael Bern, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
John F Dipersio, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Richard Hotchkiss, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Erik Dubberke, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Chris Farnsworth, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Feng Gao, Ph.D.
Email:
Sub-Investigator
Start date:
October 31, 2024
Completion date:
October 31, 2028
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Revimmune
Agency class:
Industry
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06523699
http://www.siteman.wustl.edu
