Lymphoma, Multiple Myeloma
Conditions
Brief summary
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.
Interventions
BIOLOGICALCMV-MVA Triplex Vaccine
* CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT * TDap administered on Day 56
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 28 and Day 100 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in absolute Number of CMV-induced adaptive NK Cells | Day 28 and Day 100 | 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). |
| Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients | Day 28 and Day 100 | Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100. |
| Progression Free Survival (PFS) | 1 Year | Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls |
| Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients | Day 28 and Day 100 | Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100. |
Countries
United States
Outcome results
None listed