NCT03383055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

2.6 years

First QC Date

December 11, 2017

Last Update Submit

August 11, 2021

Conditions

LymphomaMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in absolute Number of CMV-induced adaptive NK Cells

    Day 28 and Day 100

  • Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients

    Day 28 and Day 100

  • Progression Free Survival (PFS)

    1 Year

  • Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients

    Day 28 and Day 100

Study Arms (2)

CMV positive cohort

EXPERIMENTAL

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

Biological: CMV-MVA Triplex Vaccine

CMV negative cohort

EXPERIMENTAL

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

Biological: CMV-MVA Triplex Vaccine

Interventions

CMV-MVA Triplex VaccineBIOLOGICAL

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

CMV negative cohortCMV positive cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

LymphomaMultiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Study Officials

  • Armin Rashidi, MD, PhD

    University of Minnesota Hematology, Oncology and Transplantation Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 26, 2017

Study Start

November 16, 2018

Primary Completion

July 10, 2021

Study Completion

July 10, 2021

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

US(1)