CMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig

Study Overview
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Brief Summary
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This is a prospective, interventional study administering 2 doses of the experimental vaccine (CMV-MVA Triplex) to 20 evaluable patients (10 CMV-seropositive and 10 seronegative) undergoing autologous hematopoietic cell transplantation (HCT) for lymphoma or myeloma on days 28 and 56 post-HCT. The absolute number of adaptive NK cells (CD56dimCD57+NKG2C+) at various days will be compared.

Official Title
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CMV-MVA Triplex Vaccine to Enhance Adaptive NK Cell Reconstitution After Autologous Hematopoietic Cell Transplantation in Patients With Lymphoid Malignancies

Conditions
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Lymphoma, Multiple Myeloma

Intervention / Treatment
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* Biological: CMV-MVA Triplex Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Lymphoma or multiple myeloma Planned co-enrollment on current (at the time of this study version) or future (opening subsequent to this study) standard of care autologous stem cell transplant protocol. * Must meet all eligibility requirements of the co-enrolled parent study Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least day 100 post-HCT Voluntary written consent signed before performance of any study-related procedure not part of normal medical care Exclusion Criteria: CMV immunoglobulin, valganciclovir, ganciclovir, foscarnet, or other anti-CMV therapy within 3 months before the first vaccine is planned. Acyclovir and valacyclovir are allowed. Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy Planned immunotherapy post-HCT. Proteasome inhibitors and/or immunomodulators, such as but not limited to Lenalidomide or Pomalidomide, used for myeloma maintenance are allowed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMV positive cohort<br>CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT | Biological: CMV-MVA Triplex Vaccine<br>* CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT TDap administered on Day 56<br>|
| Experimental: CMV negative cohort<br>CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT | Biological: CMV-MVA Triplex Vaccine<br>* CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT TDap administered on Day 56<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the absolute number of CMV-induced adaptive NK cells (CD56dimCD57+NKG2C+) between days 28 and 100 post-auto-HCT in patients with lymphoid malignancies. | Change in the absolute number of CMV-induced adaptive NK cells (CD56dimCD57+NKG2C+) on day 28 (pre first vaccine) and day 100 ( 1 month after second vaccine) post-auto- HCT in patients with lymphoid malignancies. | Day 28 and Day 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in absolute Number of CMV-induced adaptive NK Cells | Change in absolute number of total NK and NK/T cells between days 28 (first vaccine) and day 100 ( 1 month after second vaccine) post-auto-HCT in patients with lymphoid malignancies (lymphoma and myeloma). | Day 28 and Day 100 | 
| Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients | Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100. | Day 28 and Day 100 | 
| Progression Free Survival (PFS) | Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls | 1 Year | 
| Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients | Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100. | Day 28 and Day 100 |