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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Stem Cell Transplant Complications

Intervention / Treatment
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* Drug: Zinc Sulfate Oral Product
* Drug: Levofloxacin 500Mg Oral Tablet
* Drug: Fluconazole 200mg tab
* Drug: Acyclovir 400 MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Case-control study, open, without placebo
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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 Tablet<br>* once daily from day +10 until day +30 after stem cell transplantation<br>Drug: Fluconazole 200mg tab<br>* twice daily from day +10 until day +30 after stem cell transplantation<br>Drug: Acyclovir 400 MG<br>* twice daily from day +10 until day +30 after stem cell transplantation<br>|
| Experimental: Zinc<br>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 Product<br> <br> Drug: Levofloxacin 500Mg Oral Tablet<br>* once daily from day +10 until day +30 after stem cell transplantation<br>Drug: Fluconazole 200mg tab<br>* twice daily from day +10 until day +30 after stem cell transplantation<br>Drug: Acyclovir 400 MG<br>* twice daily from day +10 until day +30 after stem cell transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variations in circulating lymphocyte populations | Flow cytometry to determine the variations of t cell subpopulations after graft | days +30, +100 after transplant | 
| Immune competence | quantitative polymerase chain reaction on peripheral blood aiming to quantify Torquetenovirus viral load | days +30, +100 after transplant | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | case report form to report side effects | days +30, +100 after transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zinc