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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Sulfate Oral Product | Drug |
| ||
| Levofloxacin 500Mg Oral Tablet |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology UO | Pisa | 56126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29747074 | Derived | 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. |
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Case-control study, open, without placebo
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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 |
|
| 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 |
| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| D013607 | Tablets |
| D015725 | Fluconazole |
| D000212 | Acyclovir |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
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