Stem Cell Transplant Complications
Conditions
Keywords
zinc
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.
Detailed description
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).
Interventions
DRUGZinc Sulfate Oral Product
once daily from day +10 until day +30 after stem cell transplantation
twice daily from day +10 until day +30 after stem cell transplantation
DRUGAcyclovir 400 MG
twice daily from day +10 until day +30 after stem cell transplantation
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Case-control study, open, without placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thymic output improvement by TRECs | 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 |
| Thymic output improvement by flow cytometry | 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
| Measure | Time frame | Description |
|---|---|---|
| Variations in circulating lymphocyte populations | days +30, +100 after transplant | Flow cytometry to determine the variations of t cell subpopulations after graft |
| Immune competence | days +30, +100 after transplant | quantitative polymerase chain reaction on peripheral blood aiming to quantify Torquetenovirus viral load |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | days +30, +100 after transplant | case report form to report side effects |
Countries
Italy
Outcome results
None listed