Status:
COMPLETED
CMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Lymphoma
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03383055
Start Date
November 16 2018
End Date
July 10 2021
Last Update
August 17 2021
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455