ClinicalTrials.gg
CompletedNCT03383055Updated Aug 17, 2021

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

A Phase 1 interventional study of CMV-MVA Triplex Vaccine in Lymphoma and Multiple Myeloma, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-17.

Sponsored by Masonic Cancer Center, University of Minnesota · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2021, 5 years 4 months ago, and no results have been posted to the registry.

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Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 31 studies in Lymphoma by Masonic Cancer Center, University of Minnesota — 1 open to participants now, 2 under way, none of them phase 3. Lymphoma · Masonic Cancer Center, University of Minnesota.

Enrollment
15th of 30
28 · median 27
Started
2018
with 1 other
Phase 1
9 of 31
none open now
Registered
28th of 31
by date

Among the 31 studies in Lymphoma by Masonic Cancer Center, University of Minnesota, this one is the 15th largest by enrollment of the 30 interventional ones that give a count, is one of 2 that started in 2018, is one of 9 in phase 1, and was the 28th registered.

Lymphoma

3,018 studies on the registry are indexed under Lymphoma; 433 are open to participants now.

Browse Lymphoma studies →

Open to participants now

1 of the 31 studies in Lymphoma by Masonic Cancer Center, University of Minnesota is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 346 Lymphoma studies recruiting now, 227 (66%) set no upper age limit and 78 (23%) stop at 75 or younger; 77 take children under 18; 20 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Lymphoma
  • Multiple Myeloma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 stem cell transplant protocol.

    * Must meet all eligibility requirements of the co-enrolled parent study

  • Sexually active females of and males with partners of child-bearing potential must agree to use adequate 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

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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    CMV positive cohort

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

    Biological: CMV-MVA Triplex Vaccine

  • Experimental
    CMV negative cohort

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

    Biological: CMV-MVA Triplex Vaccine

Interventions

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

06

What researchers measure

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.

    Time frame: Day 28 and Day 100

Secondary outcomes

  1. 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).

    Time frame: Day 28 and Day 100

  2. 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.

    Time frame: Day 28 and Day 100

  3. Progression Free Survival (PFS)

    Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls

    Time frame: 1 Year

  4. 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.

    Time frame: Day 28 and Day 100

07

Study locations

1 site
  • Masonic Cancer Center at University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Jul 2021, 31 months.

Of 138 non-industry phase 1 interventional studies under Lymphoma, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 88. This study's 31 months is below that.

Counting every sponsor, half of 281 studies reached it within 53 months; a quarter within 34 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2017
First posted
Dec 26, 2017
StartActual
Nov 16, 2018
Primary completionActual
Jul 10, 2021
CompletionActual
Jul 10, 2021
Last update
Aug 17, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03383055
Responsible party
Sponsor
First posted
Dec 26, 2017
Start date
Nov 16, 2018
Primary completion
Jul 10, 2021
Completion
Jul 10, 2021
Last update
Aug 17, 2021

Study contacts

Armin Rashidi, MD, PhD
principal investigator · University of Minnesota Hematology, Oncology and Transplantation Department of Medicine

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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