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| ID | Type | Description | Link |
|---|---|---|---|
| MT2017-29 | Other Identifier | University of Minnesota Masonic Cancer Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMV positive cohort | Experimental | CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT |
|
| CMV negative cohort | Experimental | CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMV-MVA Triplex Vaccine | Biological |
|
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| 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 |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Armin Rashidi, MD, PhD | University of Minnesota Hematology, Oncology and Transplantation Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2018 | Aug 5, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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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 |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |