NCT03159845

Brief Summary

Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are performed on peripheral blood samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_2

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

Study Start

First participant enrolled

January 1, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

5.7 years

First QC Date

May 15, 2017

Last Update Submit

January 6, 2020

Conditions

Stem Cell Transplant Complications

Keywords

zinc

Outcome Measures

Primary Outcomes (2)

  • Thymic output improvement by TRECs

    Measure of T cell receptor excision circles levels on peripheral lymphocytes (TRECs), calculated as number of copies of TRECs/mcLin droplet digital PCR

    increase of TRECs levels from day +30 until day +100 after transplant

  • Thymic output improvement by flow cytometry

    Measure of circulating T naive lymphocytes by 8-colour flow-cytometry. T naive are identified as CD4+/CD8+ lymphocytes with the coexpression of CD45RA, CD27, CD28. The value is estimated as number of T naive/mcL

    days +30, +100 after transplant

Secondary Outcomes (3)

  • Variations in circulating lymphocyte populations

    days +30, +100 after transplant

  • Immune competence

    days +30, +100 after transplant

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    days +30, +100 after transplant

Study Arms (2)

Control

ACTIVE COMPARATOR

patients undergone autologous stem cell transplantation. They take levofloxacin 500 mg/d, aciclovir 400 mg bid, fluconazole 200 mg bid from day +10 until day +30 after stem cell transplantation

Drug: Levofloxacin 500Mg Oral TabletDrug: Fluconazole 200mg tabDrug: Acyclovir 400 MG

Zinc

EXPERIMENTAL

patients undergone autologous stem cell transplantation. They take the same antimicrobial prophylaxis of patients of the Control group, and, in addition, a daily oral supplementation of Zinc Sulfate, 600 mg/die, uncoated tabs, from day +5 until day +100 after transplant

Drug: Zinc Sulfate Oral ProductDrug: Levofloxacin 500Mg Oral TabletDrug: Fluconazole 200mg tabDrug: Acyclovir 400 MG

Interventions

Zinc Sulfate Oral ProductDRUG
Zinc
Levofloxacin 500Mg Oral TabletDRUG

once daily from day +10 until day +30 after stem cell transplantation

ControlZinc
Fluconazole 200mg tabDRUG

twice daily from day +10 until day +30 after stem cell transplantation

ControlZinc
Acyclovir 400 MGDRUG

twice daily from day +10 until day +30 after stem cell transplantation

ControlZinc

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • eligibility to stem cell transplantation

You may not qualify if:

  • allergy to Zinc
  • copper deficiency or Wilson's syndrome
  • patients who admit zinc assumption in other drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology UO

Pisa, 56126, Italy

Location

Related Publications (1)

  • Iovino L, Mazziotta F, Carulli G, Guerrini F, Morganti R, Mazzotti V, Maggi F, Macera L, Orciuolo E, Buda G, Benedetti E, Caracciolo F, Galimberti S, Pistello M, Petrini M. High-dose zinc oral supplementation after stem cell transplantation causes an increase of TRECs and CD4+ naive lymphocytes and prevents TTV reactivation. Leuk Res. 2018 Jul;70:20-24. doi: 10.1016/j.leukres.2018.04.016. Epub 2018 May 2.

    PMID: 29747074DERIVED

MeSH Terms

Interventions

LevofloxacinTabletsFluconazoleAcyclovir

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDosage FormsPharmaceutical PreparationsTriazolesAzolesHeterocyclic Compounds, 1-RingGuanineHypoxanthinesPurinonesPurines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Case-control study, open, without placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 19, 2017

Study Start

January 1, 2014

Primary Completion

September 10, 2019

Study Completion

September 10, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)