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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
once daily from day +10 until day +30 after stem cell transplantation
twice daily from day +10 until day +30 after stem cell transplantation
Hematology UO
Pisa, Italy
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
Time frame: 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
Time frame: days +30, +100 after transplant
Variations in circulating lymphocyte populations
Flow cytometry to determine the variations of t cell subpopulations after graft
Time frame: days +30, +100 after transplant
Immune competence
quantitative polymerase chain reaction on peripheral blood aiming to quantify Torquetenovirus viral load
Time frame: days +30, +100 after transplant
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
case report form to report side effects
Time frame: days +30, +100 after transplant
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twice daily from day +10 until day +30 after stem cell transplantation