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

University of Minnesota (UMN)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma; Lymphoma

Treatments: Biological: CMV-MVA Triplex Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03383055

2017LS091

MT2017-29 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

CMV positive cohort

Experimental group

Description:

CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT

Treatment:

Biological: CMV-MVA Triplex Vaccine

CMV negative cohort

Experimental group

Description:

CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT

Treatment:

Biological: CMV-MVA Triplex Vaccine