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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383055
• Other study ID #: 2017LS091
• Secondary ID: MT2017-29
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2018
• Est. completion date: July 10, 2021

Study information

• Verified date: August 2021
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 10, 2021
• Est. primary completion date: July 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma

Intervention

Biological:
• CMV-MVA Triplex Vaccine
CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT TDap administered on Day 56

Locations

Country	Name	City	State
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Progression Free Survival (PFS)	Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls	1 Year
Secondary	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