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Completed

NCT Number: NCT03159845

Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies

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.

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Key information

Conditions

Stem Cell Transplant Complications

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hematology UO

Pisa, 56126, Italy

About this study

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. The aim of the study is to investigate the immune reconstitution in presence of Zinc, focused on thymic reconstitution. Laboratory tests are performed on peripheral blood samples, collected at 4 time-points: two before transplant (at the moment of the enrollment and the day before conditioning) and two after transplant (day +30 and +100).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • eligibility to stem cell transplantation

Exclusion criteria

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

Treatment and study plan

Zinc Sulfate Oral Product

Drug

Levofloxacin 500Mg Oral Tablet

Drug

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

Fluconazole 200mg tab

Drug

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

Acyclovir 400 MG

Drug

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

Primary outcomes

  1. Thymic output improvement by TRECs

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

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

  2. Thymic output improvement by flow cytometry

    Time frame: days +30, +100 after transplant

    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

Secondary outcomes

  1. Variations in circulating lymphocyte populations

    Time frame: days +30, +100 after transplant

    Flow cytometry to determine the variations of t cell subpopulations after graft

  2. Immune competence

    Time frame: days +30, +100 after transplant

    quantitative polymerase chain reaction on peripheral blood aiming to quantify Torquetenovirus viral load

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

    Time frame: days +30, +100 after transplant

    case report form to report side effects

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

A Mono-centric, No-profit, Case-control Study With Daily Oral Supplementation of Zinc Sulphate After Autologous Stem Cell Transplantation in Patients Affected by Multiple Myeloma

Acronym: ZENITH

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 19, 2017
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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